TREATMENT OF OSTEOARTHRITIS OF THE KNEE (NON-ARTHROPLASTY) FULL GUIDELINE

Adopted by the American Academy of Orthopaedic Surgeons Board of Directors December 6, 2008
This Clinical Practice Guideline was developed by an American Academy of Orthopaedic Surgeons (AAOS) multi-disciplinary volunteer workgroup that included Orthopaedic surgeons, a family physician, and two physical therapists. It is based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances. This guideline and the systematic review upon which it is based were funded by the AAOS, with additional funding received from the Arthroscopy Association of North America (AANA) and the American Orthopedic Society of Sports Medicine (AOSSM). All panel members gave full disclosure of conflicts of interest prior to participating in the development of this guideline. The AAOS received no financial support from industry or other commercial sponsors to develop this guideline or the underlying systematic review.

AAOS Clinical Practice Guideline Copyright Disclaimer This Clinical Practice Guideline was developed by an AAOS physician volunteer Work Group based on a systematic review of the current scientific and clinical information and accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not intended to be a fixed protocol, as some patients may require more or less treatment or different means of diagnosis. Clinical patients may not necessarily be the same as those found in a clinical trial. Patient care and treatment should always be based on a clinician’s independent medical judgment, given the individual patient’s clinical circumstances. Disclosure Requirement In accordance with AAOS policy, all individuals whose names appear as authors or contributors to Clinical Practice Guideline filed a disclosure statement as part of the submission process. All panel members provided full disclosure of potential conflicts of interest prior to voting on the recommendations contained within this Clinical Practice Guidelines. Funding Source This Clinical Practice Guideline was funded exclusively by the American Academy of Orthopaedic Surgeons who received no funding from outside commercial sources to support the development of this statement. FDA Clearance Some drugs or medical devices referenced or described in this Clinical Practice Guideline may not have been cleared by the Food and Drug Administration (FDA) or may have been cleared for a specific use only. The FDA has stated that it is the responsibility of the physician to determine the FDA clearance status of each drug or device he or she wishes to use in clinical practice. Copyright All rights reserved. No part of this Clinical Practice Guideline may be reproduced, stored in a retrieval system, or transmitted, in any form, or by any means, electronic, mechanical, photocopying, recording, or otherwise, without prior written permission from the AAOS.

Published 2008 by the American Academy of Orthopaedic Surgeons 6300 North River Road Rosemont, IL 60018 First Edition Copyright 2008 by the American Academy of Orthopaedic Surgeons

Summary of Recommendations
The following is a summary of the recommendations in the AAOS’ clinical practice guideline, The Treatment of Osteoarthritis (OA) of the Knee. This guideline was explicitly developed to include only treatments less invasive than knee replacement (arthroplasty). This summary does not contain rationales that explain how and why these recommendations were developed nor does it contain the evidence supporting these recommendations. All readers of this summary are strongly urged to consult the full guideline and evidence report for this information. We are confident that those who read the full guideline and evidence report will also see that the recommendations were developed using systematic evidence-based processes designed to combat bias, enhance transparency, and promote reproducibility. This summary of recommendations is not intended to stand alone. Treatment decisions should be made in light of all circumstances presented by the patient. Treatments and procedures applicable to the individual patient rely on mutual communication between patient, physician and other healthcare practitioners. Patient Education and Lifestyle Modification Recommendation 1 We suggest patients with symptomatic OA of the knee be encouraged to participate in self-management educational programs such as those conducted by the Arthritis Foundation, and incorporate activity modifications (e.g. walking instead of running; alternative activities) into their lifestyle. Level of Evidence: II Grade of Recommendation: B Recommendation 2 Regular contact to promote self-care is an option for patients with symptomatic OA of the knee. Level of Evidence: IV Grade of Recommendation: C Recommendation 3 We recommend patients with symptomatic OA of the knee, who are overweight (as defined by a BMI>25), should be encouraged to lose weight (a minimum of five percent (5%) of body weight) and maintain their weight at a lower level with an appropriate program of dietary modification and exercise. Level of Evidence: I Grade of Recommendation: A (continued on next page)

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Rehabilitation Recommendation 4 We recommend patients with symptomatic OA of the knee be encouraged to participate in low-impact aerobic fitness exercises. Level of Evidence: I Grade of Recommendation: A Recommendation 5 Range of motion/flexibility exercises are an option for patients with symptomatic OA of the knee. Level of Evidence: V Grade of Recommendation: C Recommendation 6 We suggest quadriceps strengthening for patients with symptomatic OA of the knee. Level of Evidence: II Grade of Recommendation: B Mechanical Interventions Recommendation 7 We suggest patients with symptomatic OA of the knee use patellar taping for short term relief of pain and improvement in function. Level of Evidence: II Grade of Recommendation: B Recommendation 8 We suggest lateral heel wedges not be prescribed for patients with symptomatic medial compartmental OA of the knee. Level of Evidence: II Grade of Recommendation: B Recommendation 9 We are unable to recommend for or against the use of a brace with a valgus directing force for patients with medial uni-compartmental OA of the knee. Level of Evidence: II Grade of Recommendation: Inconclusive Recommendation 10 We are unable to recommend for or against the use of a brace with a varus directing force for patients with lateral uni-compartmental OA of the knee. Level of Evidence: V Grade of Recommendation: Inconclusive (continued on next page)

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Complementary and Alternative Therapy Recommendation 11 We are unable to recommend for or against the use of acupuncture as an adjunctive therapy for pain relief in patients with symptomatic OA of the knee. Level of Evidence: I Grade of Recommendation: Inconclusive Recommendation 12 We recommend glucosamine and/or chondroitin sulfate or hydrochloride not be prescribed for patients with symptomatic OA of the knee. Level of Evidence: I Grade of Recommendation: A Pain Relievers Recommendation 13 We suggest patients with symptomatic OA of the knee receive one of the following analgesics for pain unless there are contraindications to this treatment: • Acetaminophen [not to exceed 4 grams per day] • Non-steroidal anti inflammatory drugs (NSAIDs) Level of Evidence: II Grade of Recommendation: B Recommendation 14 We suggest patients with symptomatic OA of the knee and increased GI risk (Age >= 60 years, comorbid medical conditions, history of peptic ulcer disease, history of GI bleeding, concurrent corticosteroids and/or concomitant use of anticoagulants) receive one of the following analgesics for pain: • Acetaminophen [not to exceed 4 grams per day] • Topical NSAIDs • Nonselective oral NSAIDs plus gastro-protective agent • Cyclooxygenase-2 inhibitors Level of Evidence: II Grade of Recommendation: B (continued on next page)

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Level of Evidence: II Grade of Recommendation: B Recommendation 16 We cannot recommend for or against the use of intra-articular hyaluronic acid for patients with mild to moderate symptomatic OA of the knee. Level of Evidence: V Grade of Recommendation: Inconclusive (continued on next page) v . Level of Evidence: I and II Grade of Recommendation: B Surgical Intervention Recommendation 18 We recommend against performing arthroscopy with debridement or lavage in patients with a primary diagnosis of symptomatic OA of the knee. Level of Evidence: I and II Grade of Recommendation: Inconclusive Needle Lavage Recommendation 17 We suggest that needle lavage not be used for patients with symptomatic OA of the knee. Level of Evidence: I and II Grade of Recommendation: A Recommendation 19 Arthroscopic partial meniscectomy or loose body removal is an option in patients with symptomatic OA of the knee who also have primary signs and symptoms of a torn meniscus and/or a loose body.Intra-Articular Injections Recommendation 15 We suggest intra-articular corticosteroids for short-term pain relief for patients with symptomatic OA of the knee. Level of Evidence: V Grade of Recommendation: C Recommendation 20 We cannot recommend for or against an osteotomy of the tibial tubercle for patients with isolated symptomatic patello-femoral osteoarthritis.

2008 vi . Level of Evidence: IV Grade of Recommendation: B Suggested Citation for referencing this document: American Academy of Orthopaedic Surgeons Clinical Practice Guideline on the Treatment of Osteoarthritis of the Knee (Non-Arthroplasty). Level of Evidence: IV and V Grade of Recommendation: C Recommendation 22 We suggest against using a free-floating interpositional device for patients with symptomatic unicompartmental OA of the knee. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS).Recommendation 21 Realignment osteotomy is an option in active patients with symptomatic unicompartmental OA of the knee with malalignment.

Goldberg. Turkelson. Wies MPH Clinical Practice Guidelines Manager 6300 N River Road Rosemont. MA 02120 Guidelines and Technology Oversight Vice-Chair: Michael J. IL 60018 Elizabeth G. TX 77030 David Hunter MBBS. MBA Medical Director 6300 N River Road Rosemont. Ph. A41 Cleveland. Suite 3200 1115 W. MA 02111 Research Analysts Sara Anderson MPH Kevin Boyer Patrick Sluka MPH Justin St. MD Hospital for Special Surgery 535 E 70th St New York. DE 19716 AAOS Staff: Robert H. MD 2500 Metro Health Drive Cleveland. ScD Department of Physical Therapy University of Delaware 309 McKinly Lab Newark. NY 10021 Bruce A Levy. Florida 32306-4300 Charles M. Haralson III. Watters III MD 6624 Fannin #2600 Houston.Workgroup Conflict of Interest information for workgroup members is available in the appendixes. MD. IL 60018 Daniel Van Durme MD Dept. WA 98105 James Irrgang PT. PhD New England Baptist Hospital 125 Parker Hill Avenue Boston. PA 15213 Evidence Based Practice Committee Chair: Michael Keith. Dept of Orthopaedic Surgery University of Pittsburgh School of Medicine Kaufmann Medical Building. #2 Airmont. PhD Director of Research and Scientific Affairs 6300 N River Road Rosemont. Chair New England Baptist Hospital 125 Parker Hill Avenue Boston. IL 60018 Cheryl Rubin. Matzkin. MD Tufts – New England Medical Center Department of Orthopaedics 750 Washington Street Boston. OH 44195 Lynn Snyder-Mackler PT. Pittsburgh. OH 44109-1900 Morgan H. MD Rockland Orthopedics & Sports Medicine 327 Route 59. Call Street Tallahassee. MD Department of Orthopaedics Seattle Children’s Hospital 4800 Sand Point Way NE Seattle. John Richmond MD. Jones MD 9500 Euclid Ave. of Family Medicine and Rural Health Florida State University. Suite 911 3471 Fifth Ave. SCS. ATC Associate Professor and Director of Clinical Research. MN 55905 vii . MLS 2007 -2008 Intern Michelle Scott. NY 10952 Janet L. ATC. Andre MS Medical Librarian Richard McGowan. MA Robert G Marx.D. MSc. MD Mayo Clinic 200 First St SW Rochester. MA 02120 Guidelines and Technology Oversight Chair: William C.

five outside peer review organizations were invited to review the draft guideline and all supporting documentation. For this guideline. All five societies participated in the review of the Treatment of Osteoarthritis (non-arthroplasty) guideline draft and three consented to be listed as a peer review organization in this appendix. These experts represent professional societies other than AAOS and are nominated by the guideline workgroup prior to beginning work on the guideline.Peer Review Participation in the AAOS guideline peer review process does not constitute an endorsement of this guideline by the participating organization. viii . Peer review of the draft guideline is completed by an outside Peer Review Advisory Panel. Two organizations did not give explicit consent that the organization name could be listed in this publication. Outside Advisory Panels are convened for each AAOS guideline and consist of experts in the guideline’s topic area. The organizations that reviewed the document and consented to publication are listed below: The Arthroscopy Association of North America (AANA) The American Orthopeadic Association (AOA) The American Physical Therapy Association (APTA) Participation in the AAOS guideline peer review process does not constitute an endorsement of the guideline by the participating organizations listed above.

....................................................................................................viii Table of Contents........................... 10 Revision Plans ........................................Table of Contents Summary of Recommendations ...................................... 9 Statistical Methods ................................................................... 2 Incidence ........ 6 Literature Searches .............................................. 9 Consensus Development........................................................................................................................................................................................4 Simulated Recommendations ................................. 10 The AAOS Guideline Approval Process........................................................................................................................................................................................................................................ 2 Burden of Disease ................................................................................................................................................................................................................................................................................................................................................................................................... 2 Risk Factors ........................................................................................................................ 11 ix ........ 10 Peer Review.......................................................................................................... 3 II................................................................................................................................................................................................................................................................................................. 8 Data Extraction.......................................................... 2 Prevalence .......................................................................................................................................................................................................................................................................................................................................................................................................................................................................... 7 Judging the Quality of Evidence ....................................................................ix List of Tables............................ 1 Patient Population ..................... INTRODUCTION ...................................................................................... Harms....................................... 8 Grading the Recommendations..................................................................................... 2 Emotional and Physical Impact of Osteoarthritis of the Knee ....ii Workgroup.................................................................................................................................................................................................................................................................................................. 1 Intended Users ..............vii Peer Review................................................................. 2 Etiology................................................ 10 Public Commentary.................................................................................................................................................1 Overview ..................................................................................................................... 1 Goals and Rationale .................................................................................................................... METHODS............. and Contraindications .........................................xii I....xii List of Figures ......................... 3 Potential Benefits........................................................................................... 4 Minimal Clinically Important Improvement ..... 4 Study Selection Criteria ...........................................................................................................................................................................................................................................................................................................................................

.............................................................................................................................................. 183 Recommendation 22: Free-Floating Interpositional Device ............................................................ RECOMMENDATIONS AND SUPPORTING DATA ........................................................................................................................................................................................................................... 42 Recommendation 11: Acupuncture........................ 135 Recommendation 18: Arthroscopy for Primary Osteoarthritis of the Knee.......................................................... 181 Recommendation 20: Tibial Tubercle Osteotomy ............................................................................. 203 Future Research ......................................... 15 Recommendation 4: Low-Impact Aerobic Fitness Exercises......... 13 Recommendation 2: Regular Contact to Promote Self-Care ........................................................................................................................ 208 x ...... 102 Recommendation 13: Analgesics for Pain ............................................................................................................................................................................................................................................ 30 Recommendation 9: Braces (Valgus Directing Force) ........ 108 Recommendation 16: Intra-articular Hyaluronic Acids .............. 43 Recommendation 12: Glucosamine and Chondroitin ..................................................... 133 Recommendation 17: Needle Lavage .......................................................................................................................................................................................................12 Recommendation 1: Self-Management.............. 26 Recommendation 8: Lateral Heel Wedges ............................................. 104 Recommendation 14: Analgesics for Pain with Increased Gastrointestinal Risk ............................. 18 Recommendation 6: Quadriceps Strengthening ................................................ 37 Recommendation 10: Braces (Varus Directing Force)..... 17 Recommendation 5: Range of Motion/Flexibilty Exercises ................................................... 160 Recommendation 19: Arthroscopic Meniscectomy/Loose Body Removal .................... 182 Recommendation 21: Realignment Osteotomy...................................................................................................................... 106 Recommendation 15: Intra-articular Corticosteroids........................................................................................... 14 Recommendation 3: Weight Loss................................ 19 Recommendation 7: Patellar Taping ....................................................................................III................................................................................

................................................................ 218 Literature Searches for Systematic Reviews.............. 228 Appendix XI......................................................... 223 Rating the Quality of Systematic Reviews with AMSTAR...................................................................... 211 Documentation of Approval ............................... 228 Structured Peer Review Form...........................................................................................................................................................................................................................................IV................................................................................................................................................................................................................................................................................................................................ 235 References .............. 227 Appendix X ............................................................................................................................ 222 Appendix VI..................................................... 245 Excluded Articles............................................................................................................................................................................................................................................................................................................................................................................................ 218 Literature Searches for Primary Studies . APPENDIXES ........................................................................... 222 Level of Evidence ........ 231 Appendix XII .......................................................................................... 219 Appendix V ........................................209 Appendix I................................................................................................... 225 Form for Assigning Grade of Recommendation (Interventions) ................................................. 210 Appendix II ................ 235 Included Articles.................................................................................................................... 233 Appendix XIII................ 225 Appendix IX.................................................................................................................. 253 xi ......................................... 224 Data Extraction Elements ........ 224 Appendix VIII...... 227 Voting by the Nominal Group Technique ............................................................................................................................. 223 Appendix VII .................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................................... 213 Study Attrition Flowcharts ............................................................ 233 Evidence Tables...................................................................................................................................................................................... 213 Appendix IV....................................................................................................................................................................................................................................................................... 231 Conflict of Interest............................. 211 AAOS Bodies That Approved This Clinical Practice Guideline .............................................................................................................................. 212 Appendix III........... 210 Workgroup........................................................................

....WOMAC Pain (52 weeks)......... Pain ...................................................................... 29 Figure 10........ Control ...................................GAIT Results ..................... Subtalar Strapped Insoles ................................ Summary of Evidence from OARSI for NSAIDs ..... 105 Table 12. AAOS Analysis: WOMAC Pain Excluding Petrella RCT............ Medial vs................................ Acupuncture vs.... Sock-type Inserted vs..... Acupuncture vs................................................. VAS Pain..................................... Conclusions of Previously Published Systematic Reviews on Acupuncture in Patients with OA of the Knee ............................................WOMAC Pain (4-5 weeks)................ Lateral vs.............. Acupuncture vs... 35 Figure 15........... Subtalar Strapped Insoles .............. Control ...... Summary of Evidence from OARSI for Acetaminophen ... Summary of Evidence from OARSI for Topical NSAIDs .......................... Medial vs...... 51 Figure 28.....................................................Pain ........... Complications and Adverse Events exceeding 10% of Enrolled Patients .......................... 202 List of Figures Figure 1............. 52 Figure 30.VAS Pain (12 weeks) ............... 103 Table 10........... 46 Figure 23....................... 35 Figure 16.................................................................................... 17 Table 5......................................................WOMAC Pain (6-8 weeks)................................. AAOS Analysis: WOMAC Function Using Change Scores........... Subtalar Strapped Insoles – Pain: VAS .............. 28 Figure 9.......................WOMAC Pain (26 weeks)..................................................................................................................... 44 Table 6................................... Results of Meta-Regression of Effect of Level of Patient Blinding on Effect Size............................................ 31 Figure 11........................................................................................................................................................................................................................ AAOS Analysis: WOMAC Pain ....WOMAC Pain (26 weeks) .................................................... 24 Figure 5... Neutral Heel Wedge ............................................... 53 Figure 33..... Control .................................................................................................................................................... No Taping – Pain: VAS.................................. Summary of Evidence from OARSI for Acupuncture.WOMAC Pain (12-14 weeks) ........... 56 xii ............ 33 Figure 13................................................................................ Summary of Evidence from OARSI for Weight Loss ......................................................... Placebo ......... 53 Figure 32... 48 Figure 25.............. Acupuncture vs......................................... 36 Figure 17... Acupuncture vs...................................................................... Subtalar Strapped Insole ........................................ Quality of Life (EQ-5D)................ 54 Figure 34..................................... 47 Figure 24. Walking Distance ............................... Control ..................... Lateral vs......VAS Pain (4-5 weeks)................................................... 32 Figure 12............................ Acupuncture vs............ Inserted vs...................... Control .................. Traditional Inserted vs................................ Lateral vs................................................................................................................ Summary of Evidence from AHRQ Report ............ AAOS Analysis: WOMAC Function............ 105 Table 11.............. Lateral vs. Placebo .... 52 Figure 31................. Summary of Evidence from OARSI for Aerobic Exercise................. Sham Taping – Pain: VAS ..... 55 Figure 35............................ Function ... Walking Distance Change from Baseline ............... Acupuncture vs.Review Conclusions......................................................................................... 16 Table 4................... Acupuncture vs. Control .............. Neutral Heel Wedge .................WOMAC Pain (6-8 weeks) ............................................................... 103 Table 9.......... 14 Table 3...WOMAC Pain (4 weeks) ............Adverse Effects... Acupuncture vs........................................................... 40 Figure 21.................. 38 Figure 18...................... Acupuncture vs................................... 40 Figure 20.................................................................................. Control .............................WOMAC Pain (12-14 weeks)....................................................... 34 Figure 14...............................Function .... Placebo .............................................. 49 Figure 26. Traditional Inserted vs... Placebo . Placebo .................................... 50 Figure 27..... 41 Figure 22................................................... Acupuncture vs................................................................. 25 Figure 7...... 39 Figure 19........... 47 Table 8.................................................................. Summary of Evidence from OARSI for Self-Management....................................................................................... Acupuncture vs..... HSS ........................................ 22 Figure 4... 13 Table 2...... 21 Figure 2................... 51 Figure 29.......... 22 Figure 3....WOMAC Pain (52 weeks) ........... Placebo .... Acupuncture vs..............Patient Global Assessment .. Sham Taping – Pain:VAS .......................... Neutral Heel Wedge – WOMAC.. 107 Table 13.......Medication Intake............................... 27 Figure 8............... Placebo ...................List of Tables Table 1...Lequesne Index......... 44 Table 7. Summary of Evidence from OARSI for Regular Telephone Contact ......................................Lequesne Index..... 24 Figure 6.......................... Summary of Evidence from AHRQ Report ................... Acupuncture vs............

68 Figure 56.. Control ...................... Acupuncture vs...................... Placebo -Present Pain Intensity ..................... Control ....... Acupuncture vs.......................... Placebo ........WOMAC Function (12-14 weeks)........... Control ................NRS Pain Unpleasantness.........WOMAC Function (52 weeks) ....................................... Acupuncture vs. Control ..... Acupuncture vs.... 59 Figure 41....................................WOMAC Total.....................SF-12 Physical Scale ..................... Acupuncture vs............... Acupuncture vs... Control .................................................................. Acupuncture vs. 92 Figure 91................... 58 Figure 39................................ Placebo ............................................ Acupuncture vs............ Control ........ Acupuncture vs..NRS Severity of Main Functional Problem .............. 64 Figure 49.. Control – NRS Pain.... Control .... Control ............................................ Control -Patient Global Assessment.... Control ............ Acupuncture vs.................. 89 Figure 86.......................................................................................... Placebo – SES Affective Pain ....... Placebo ... Acupuncture vs. 90 Figure 88........................................ 70 Figure 60.............. 77 Figure 70..........6-Minute Walk Distance..WOMAC Stiffness (4 weeks)................................WOMAC Total (4-8 weeks) ...... Control ... Placebo – NRS Pain Intensity ................................... Acupuncture vs........... 91 Figure 90. 84 Figure 78.Pain Disability Index................................. 64 Figure 50................ Placebo ...... Control ................... Acupuncture vs.... Control .. Acupuncture vs..........SES Affective Pain ..................................................................Pain Disability Index ....... Acupuncture vs............Timed Up and Go .Figure 36........ Control .... Acupuncture vs...... Placebo ... 89 Figure 87...............SF-12 Physical Scale. 86 Figure 82.....................................................Patient Global Assessment..................................... Placebo ..... 69 Figure 58................... Acupuncture vs.................Patient Global Assessment ........................ Acupuncture vs....Pain Rating Index ... 66 Figure 53. Acupuncture vs.............. Acupuncture vs............6-Minute Walk Distance .........Lequesne Index ................... Acupuncture vs.................. Acupuncture vs............. Placebo – NRS Severity of Main Functional Problem ..................................WOMAC Stiffness (all durations) ................................. Placebo ............................................... Acupuncture vs......................... Acupuncture vs.. Acupuncture vs................... 69 Figure 57... Acupuncture vs... Acupuncture vs............... 75 Figure 67......... 79 Figure 72.... Acupuncture vs................... Control .......................................................................WOMAC Total (26 weeks)...................50-m Walk Time........ Placebo – SES Sensoric Pain ................................................. 79 Figure 73................ Acupuncture vs......... Acupuncture vs....... Acupuncture vs......... 56 Figure 37.......... 86 Figure 83.................. 85 Figure 80......................................... 72 Figure 64. 87 Figure 84......... Acupuncture vs.... 65 Figure 52.......... Placebo ......... Placebo . Placebo ............. Placebo ..... Acupuncture vs....... Acupuncture vs................................................................. Placebo -Patient Global Assessment .... 73 Figure 65..SF-36 Physical Health Score.......................... Acupuncture vs...................... 76 Figure 68................................. Acupuncture vs.. Placebo ...................................... Placebo ................ 74 Figure 66................................WOMAC Function (6-8 weeks) .............................................WOMAC Stiffness (8-52 weeks) ................... 88 Figure 85.... Acupuncture vs.................................................................................................. 85 Figure 81......SF-36 Mental Health Score....... 61 Figure 46..................WOMAC Function (52 weeks).......... 91 Figure 89............................... Acupuncture vs...................50-ft Walk Time ................... Placebo – NRS Pain Unpleasantness..... Control ................................ 63 Figure 48......... 80 Figure 74............. 60 Figure 43....... Control – SES Sensoric Pain...........................WOMAC Function (4 weeks)..................... 57 Figure 38. Acupuncture vs... Acupuncture vs.................................. Control .......... Control .................................. Acupuncture vs.......... Acupuncture vs............................. Control ......................................................... 65 Figure 51.......WOMAC Total (12-13 weeks) ....SF-12 Mental Scale.......................Climb 20 Stairs Time.......WOMAC Function (6-8 weeks) ....... 61 Figure 45. Control ... Acupuncture vs................WOMAC Function (26 weeks)....................... 71 Figure 62.......... Placebo ...Depression.............................. 67 Figure 55................ 92 xiii .............. Acupuncture vs......... 78 Figure 71............................... Acupuncture vs.................SF-36 Mental Health Score ....................................................... 59 Figure 42.................. Acupuncture vs........... Control . 70 Figure 59.... 71 Figure 61.................. 83 Figure 77................. 62 Figure 47............................ Acupuncture vs............ Acupuncture vs.............. Acupuncture vs........................................................................................................ Acupuncture vs. 76 Figure 69.....SF-12 Mental Scale ......... 60 Figure 44.........................WOMAC Function (26 weeks) ............................... Acupuncture vs......................................... Control – NRS Pain Intensity..... 67 Figure 54............Lequesne Index...... Control ............................. Placebo . Control ......................................................................................................................................... Acupuncture vs....................................... Placebo .......SF-36 Physical Health Score ......... Placebo ..............................VAS Pain ............... 81 Figure 75................................... Placebo ..................Depression -ADS ....... Control . 82 Figure 76..WOMAC Function (4 weeks) ...................................... Acupuncture vs.............................. 58 Figure 40.................. Placebo – PLQC........... Control ............WOMAC Function (12-14 weeks) ......................................................... Acupuncture vs....................... Control ... Placebo .......................... Acupuncture vs... 84 Figure 79........................................................... Acupuncture vs... 72 Figure 63.........................................

............................................................. 146 Figure 139....Responders (26 weeks) ............................. 138 Figure 131........ 140 Figure 133.............................................................. Function as measured by WOMAC ................................................................... Control ....... 93 Figure 93...................... 153 Figure 147........................................ 50-foot walk measured in seconds ............................................................. Pain after walking 50 feet measured by VAS ........................... Days with stiffness last week ....... Function measured by Lequesne Index ................................................ Patient global assessment measured by 10-cm VAS................ 126 Figure 122........... 149 Figure 143............................ Total number of withdrawals ........................................ Patients with greater than fifteen percent reduction in pain ......................... Acupuncture vs.............. 94 Figure 95....................................................... Control – Responders (6-13 weeks) ............................ 129 Figure 125..................... Placebo ..................... Walking pain measured by VAS ........................................ 123 Figure 119................. Acupuncture vs.............................................. Placebo .................................................................. 117 Figure 113................ 142 Figure 135.......Serious Adverse Events .......Responders (52 weeks).......... Patients reporting local discomfort.................................................................................................................... Knees with improvement at all durations (weighted mean difference) ............ 141 Figure 134....... Acupuncture vs....... 149 Figure 142......................................................................... 96 Figure 98............................................................................ 115 Figure 111..... Function measured by AIMS ................. Control ................. Acupuncture vs............. Stiffness as measured by WOMAC................. Pain at rest measured by VAS............................................................................... Acupuncture vs......... 111 Figure 107................ 113 Figure 109. 136 Figure 129..... 95 Figure 96................................................................................... Total number of withdrawals due to lack of efficacy.. 122 Figure 118............ Acupuncture vs. 144 Figure 137...................... 148 Figure 141........................................................................ Knees with improvement after two weeks ...................................... Control ................................................................................................................................ 147 Figure 140. 50............... Physical activity measured by AIMS .................. Function measured by HAQ................................... WOMAC stiffness measured by 100 mm VAS ............... 98 Figure 100.................................... Acupuncture vs.... 110 Figure 106.......................................................................... Control ..........................................................Medication Intake.Serious Adverse Events.................................................................................. 114 Figure 110.......................................... Acupuncture vs...................................... Global assessment measured by 100 mm VAS...................................................... 132 Figure 128..... 101 Figure 104........................................................... 99 Figure 102......................foot walk measured in seconds ............................ Patients with greater than thirty percent reduction in pain...... Placebo ... 50-foot walk time measured in seconds ....................Adverse Events ....................... Pain after climbing four stairs measured by VAS ... 112 Figure 108................................................................................ 120 Figure 116........................................................................................................................ 152 Figure 146....................................................... 143 Figure 136................................. 99 Figure 101.. Acupuncture vs..... WOMAC physical function measured by 100 mm VAS ....................... 127 Figure 123......................Adverse Events.................................................................................................. 116 Figure 112............ Pain at night measured by 100 mm VAS ....Responders (52 weeks) ........................................................... Pain measured by 100 mm VAS .... Patients with improved global assessment ........... Placebo – Responders (4-13 weeks)............................................. Acupuncture vs......................................................................... 131 Figure 127............................................ WOMAC pain assessment measured by 100 mm VAS .......................................Responders (26 weeks)......... 151 Figure 145.............. 130 Figure 126...................................................... WMD in pain measured by VAS .. Placebo ...................................................................................................................................................................................... Control ...................... Pain measured by AIMS ..................... Distance walked over one minute measured in meters................ 50-foot walk measured in seconds ............... Acupuncture vs.............................................. Patients with post injection flare ....... Number of Patients preferring treatment..........Range of Motion ................. Placebo ................................... Total WOMAC score measured by 100 mm VAS .............................................. 100 Figure 103................................................ Time needed to climb four stairs measured in seconds ................................ Knees with improvement at two week duration (odds ratio). 121 Figure 117....................... 118 Figure 114. 128 Figure 124..................................... Quality of well-being ............................. 137 Figure 130............................. 150 Figure 144..... 109 Figure 105................................. 94 Figure 94............... Most intense pain yesterday measured by VAS ...................................... Pain at night measured by VAS .............................Figure 92...................................... 145 Figure 138........ 125 Figure 121................................................................................................. Patients reporting pain reduction....... 139 Figure 132.............................. Social activity measured by AIMS..... Patient pain measured by WOMAC...... 119 Figure 115................................................................................................................... Acupuncture vs................................... 154 xiv ....................................................................................... 97 Figure 99.......................................................... 95 Figure 97............ 124 Figure 120...............

................................................ Pain measured by KSPS – Lavage .......................................... Walking-bending measured by AIMS – Lavage .. 157 Figure 151...................................................................................Figure 148............. 165 Figure 158......................................................................................................................... Physical function measured by AIMS – Debridement ......................... Acetaminophen use measured by count ........................... Knees with swelling ..................................................................... Pain measured by SF-36 – Lavage .... 201 Figure 197: Mean Pain Scores (VAS) ........................................................ 190 Figure 183: Mean WOMAC Stiffness Score Ilizarov HTO .................................................................................................. 192 Figure 187: Mean Symptoms KOOS... Patients with pain free knees – Lavage & Debridement ..................... 187 Figure 180: Percent of Patients with Pain While Walking .......................................................... 205 Figure 199: Mean Knee Society Function Score ....................................................... 206 Figure 201: Cumulative Percent of Revisions ............................ 198 Figure 194: Mean Lysholm Score ......................................................... 188 Figure 181: Percent of Patients with Improvement in Pain ........................ Pain measured by AIMS – Lavage....................................... 198 Figure 193: Mean Lysholm Scores.................................................. Pain measured by KSPS – Debridement & Lavage ............................................................. 184 Figure 176: Mean KOOS Pain Score............................ 200 Figure 196: Percent Survival ................................. Physical function measured by AIMS** – Debridement ..................................................................................................................................... 192 Figure 186: WOMAC Function Score Coventry HTO............ Function measured by WOMAC – Lavage ............ 167 Figure 160......................................................................................................................... 179 Figure 173................................................................................................................. Knee stiffness measured by WOMAC – Lavage ........................................... 172 Figure 166........... 171 Figure 165.... 185 Figure 177: WOMAC Pain Score Ilizarov HTO ..................... 161 Figure 154............................................................................................................... 197 Figure 192: Mean Lysholm Score ............................................. Pain measured by KSPS – Debridement .............................................................................................................................. 184 Figure 175: Mean VAS Pain Score opening wedge HTO ................................................................................. 195 Figure 190: Knee Related Quality of Life KOOS .............. 191 Figure 185: Mean WOMAC Function Score Ilizarov HTO ........................ 207 xv ............................................................................................................. 186 Figure 178: Mean WOMAC Pain Score Coventry HTO......................................................................... Pain measured by WOMAC – Lavage .............................................................................. Physical function measured by AIMS** – Debridement & Lavage ............ 155 Figure 149.................... 186 Figure 179: Percent of Patients with Pain at Rest............................................... 176 Figure 170...................... Patient function measured by SF-36 – Lavage............................................................. 194 Figure 189: Mean Sports and Recreational Function Score KOOS................................................................................................................................................................................................................................................. 164 Figure 157.................................. 159 Figure 153......................................................... 175 Figure 169.................................................. 196 Figure 191: Mean Walking Distance...................................................................................................... 206 Figure 200: Mean Knee Society Objective Scores ......................................................... 174 Figure 168.... 189 Figure 182: Percent of Patients with Reduction in Pain using VAS Scale ................................................................... 178 Figure 172.................................... 163 Figure 156................................. 204 Figure 198: 26 Months Post-Operative Presence of Pain While Walking.................................... 193 Figure 188: Mean Activities of Daily Life KOOS ................................................................................ 191 Figure 184: Mean WOMAC Stiffness Score Coventry HTO..................................................................................... 166 Figure 159.................................................................................................................. Anxiety measured by AIMS........................................................... 207 Figure 202: Percent Revised to TKA .............................................. Pain measured by AIMS – Debridement............ 177 Figure 171........................................................................ 180 Figure 174: Mean VAS Pain Score in closing wedge HTO ................................................................................................... 173 Figure 167...... 169 Figure 163.......... Knees with tenderness............................................................................................................................................................................................. 158 Figure 152............................................. Depression measured by AIMS........................................... 156 Figure 150......................................................................................... 170 Figure 164...................................................................... 168 Figure 162.................................................. 168 Figure 161............................................... Pain measured by 10 cm VAS – Lavage.......... Aggregate WOMAC – Lavage................................................................................ Physical Functioning Scale – Lavage.................................................... Function measured by Lequesne Index – Lavage ................. 199 Figure 195: Patient Opinion of Results ........................... Pain measured by 100 mm VAS – Lavage........................................................................... Global assessment measured by VAS – Lavage ...... 162 Figure 155................................................................................................................................................

Current evidence-based practice (EBP) standards demand that physicians use the best available evidence in their clinical decision making. and what topics future research must target in order to improve the treatment of patients with OA of the knee. We created this guideline as an educational tool to guide qualified physicians through a series of treatment decisions in an effort to improve the quality and efficiency of care. To assist in this. The systematic review detailed herein was conducted between October 2007 and February 2008 and demonstrates where there is good evidence. INTENDED USERS This guideline is intended to be used by orthopaedic surgeons and all qualified physicians managing patients with OA of the knee. standardized process. where evidence is lacking. However. this clinical practice guideline consists of a systematic review of the available literature regarding the treatment of osteoarthritis of the knee. knee replacement. but not including. This guideline is intended to be used by all appropriately trained surgeons and all qualified physicians considering treatment of OA of the knee. Insurance payers. governmental bodies. AAOS staff and the OA of the Knee physician workgroup systematically reviewed the available literature and subsequently wrote the following recommendations based on a rigorous. this guideline also highlights gaps in the literature and areas that require future research. Typically. treatment for OA of 1 . INTRODUCTION OVERVIEW This clinical practice guideline is based on a systematic review of published studies on the treatment of osteoarthritis (OA) of the knee in adults.1 but rather can be used for confirmation if necessary by excluding other diagnoses including rare conditions such as osteochondritis dissecans. and some may have completed additional sub-specialty training. and health-policy decision-makers may also find this guideline useful as an evolving standard of evidence regarding treatment of OA of the knee. tumors. and other conditions. It covers treatment up to. orthopaedic surgeons will have completed medical training. GOALS AND RATIONALE The purpose of this clinical practice guideline is to help improve treatment based on the current best evidence. In addition to providing practice recommendations. a qualified residency in orthopaedic surgery. Diagnosis of OA of the knee is commonly made on the basis of signs and symptoms. The ultimate judgment regarding any specific procedure or treatment must be made in light of all circumstances presented by the patient and the needs and resources particular to the locality or institution. Radiographic evidence is not necessary for the diagnosis of OA. It is also intended to serve as an information resource for decision makers and developers of practice guidelines and recommendations.I. Musculoskeletal care is provided in many different settings by many different providers. This guideline should not be construed as including all proper methods of care or excluding methods of care reasonably directed to obtaining the same results.

This guideline does not address patients diagnosed with rheumatoid arthritis or other inflammatory arthropathies. and twelve percent for adults 60 years and older. over 45 years of age are afflicted. especially for women.2 Further.000 person years. The guideline provides information on patient management postdiagnosis up to. PATIENT POPULATION This document addresses the treatment of OA of the knee in adults (defined as patients 19 years of age and older).1%. INCIDENCE OA of the knee incidence in the United States is estimated at 240 per 100. 3 PREVALENCE It is difficult to estimate the prevalence of osteoarthritis disease because there are no universally applicable criteria for its diagnosis.1 million ambulatory care visits in 2004 and “an estimated 9.4 17%. an informed decision can be made.”2 ETIOLOGY Osteoarthritis results from an imbalance between breakdown and repair of the tissues of the synovial joint organ that occurs as a result of multiple risk factors including trauma and genetic predisposition.2 The prevalence of symptomatic OA of the knee is estimated at 5%.3 Additional factors that increase the risk of developing OA of the knee include genetics.6 Estimates vary by age group. RISK FACTORS Occurrences of OA of the knee increase with age. specific occupations. Clinician input based on experience with both conservative management and surgical skills increases the probability of identifying patients who will benefit from specific treatment options.3 million adults had symptomatic OA of the knee in 2005.2. According to a number of studies. but not including. Once the patient has been informed of available therapies and has discussed these options with his/her physician. seventeen percent for adults 45 years and older. but between 7% and 19% of women. repetitive knee bending or heavy lifting. and strong family history. anywhere from 6% to over 13% of men.5 and 12. there is often no correlation between symptoms and clinical signs of OA of the knee. BURDEN OF DISEASE Osteoarthritis (of any joint) was the primary diagnosis in 11. knee replacement (arthroplasty).2 resulting in a 45% less risk of incidence for men.7 2 . excess body mass. five percent referring to adults who are 26 years and older.the knee is based on the assumption that decisions are predicated on patient and physician mutual communication with discussion of available treatments and procedures applicable to the individual patient.

Current demographic trends. Therefore. discussion of available treatments and procedures applicable to the individual patient rely on mutual communication between the patient and physician. The aim of treatment is pain relief and improvement or maintenance of the patient’s functional status. and the higher recreational activity levels of our elderly population suggest that the emotional and physical impact of OA will continue to increase in the future. Most treatments are associated with some known risks. and functional deficits.9 report that elderly persons with self-reported OA visit their physicians more often and experience more functional limitations than others in their age group. HARMS. 3 . especially invasive and operative treatments. In addition. and knee increases with age. the rise in rates of morbid obesity.2 POTENTIAL BENEFITS.EMOTIONAL AND PHYSICAL IMPACT OF OSTEOARTHRITIS OF THE KNEE Olivera et al. weighing the potential risks and benefits for that patient. Felson et al. AND CONTRAINDICATIONS Individuals with OA of the knee often complain of joint pain. 8 report that the incidence of OA of hand. contraindications vary widely based on the treatment administered. stiffness. hip. including the aging of the baby boomer population. Long term results were often not available and adverse events varied by study (frequently they were not reported) in the literature available for this guideline. and women have higher rates of OA than men especially after age 50.

This guideline and systematic review were prepared by the AAOS Treatment of Osteoarthritis of the Knee guideline workgroup with the assistance of the AAOS Guidelines Unit (Appendix I). This section describes the methods used to prepare this guideline and systematic review. it was supplemented by the consensus opinion of the workgroup. not as final recommendations or conclusions. [when]. The methods used to perform this systematic review were employed to minimize bias in the selection and summary of the available evidence. These recommendations specify [what] should be done in [whom]. once specified. and then sequentially approved by the AAOS Evidence Based Practice Committee.II. and the AAOS Board of Directors (see Appendix II for a description of the AAOS bodies involved in the approval process) SIMULATED RECOMMENDATIONS The workgroup began work on this guideline by constructing a set of simulated recommendations. the workgroup held multiple teleconferences and participated in a two-day recommendation meeting at which the final recommendations were written and voted on. transparent. Simulated recommendations are almost always modified on the basis of the results of the systematic review. the workgroup unanimously agreed to refer to the AHRQ evidence report 12 to address recommendations 12 and 16. These recommendations also form the guideline’s scope and guide the searches for literature. [where]. The a priori and inviolate nature of the simulated recommendations combats bias.10. and to refer to the OARSI guidelines 13. subsequently sent for public commentary. and the review and approval of the guideline. they must all be addressed by the systematic review. When information from the literature was sparse or lacking. criteria for selecting eligible articles. grading the evidence. 14 to address 4 . they cannot be modified. AAOS Council on Research. These a priori simulated recommendations are inviolate in that. They function as questions for the systematic review. Accordingly. Quality Assessment. METHODS This clinical practice guideline and the systematic review upon which it is based evaluates the effectiveness of treatments for OA of the knee up to. data extraction. and accurate clinical recommendations for treating OA of the knee. to address certain recommendations and a previously published clinical practice guideline to address certain other questions. and the relevant review results must be presented in the final guideline. “Treatment of Primary and Secondary Osteoarthritis of the Knee”. AAOS Guidelines and Technology Oversight Committee. knee replacement surgery. To develop this guideline. and Technology. STUDY SELECTION CRITERIA TYPES OF STUDIES The physician workgroup also decided to exclusively use an Agency for Healthcare Research and Quality (AHRQ) evidence report. and [how often or how long]. The resulting draft guidelines were then peer-reviewed. including search strategies used to identify literature. methods of statistical analysis. 11 These processes are vital to the development of reliable. but not including.

9. Was not a letter. but the original studies did. we use them to address recommendations 6. we sequentially searched for prospective controlled trials. Except for one recommendation (recommendation 18). We addressed the remaining recommendations (recommendations 5.16. editorial. When examining primary studies we analyzed the best available evidence regardless of study design. and 18. We first searched for published systematic reviews that examined the clinical effectiveness of treatments for OA of the knee. not a meeting abstract Was published in the peer-reviewed literature Was not a cadaveric. In the absence of two or more RCTs. 10. retrospective comparative studies. 7. Reported quantified results Was a full article. we included only these reviews when they were available. For recommendation 18. 15. 8. we included these original studies in our analysis. to be included in our systematic reviews an article had to be a report of a study that: • • • • • • • • • • Evaluated a treatment for OA of the knee Enrolled a patient population of at least 80% of patients with OA of the knee. Therefore. We first considered the randomized controlled trials identified by the search strategy. published studies. 13. We developed a priori article selection criteria for our review. 4. 16. case report. 18. prospective comparative studies. up to but not including knee replacement surgery. 19. ARTICLE INCLUSION CRITERIA FOR DE NOVO SYSTEMATIC REVIEWS We developed a priori inclusion criteria that articles had to meet to be included in our de novo systematic reviews. or commentary Enrolled ≥ 10 patients in each of its study arms Enrolled a patient population of ≥ 80% or more of patients 19 years of age or older Was an English language article 5 . Specifically. animal or in vitro study. We addressed the remaining recommendations by conducting our own systematic reviews of the literature. 11. 17 As a result of our searches for published systematic reviews. 2. 3.recommendations 1. 21. one of the two relevant systematic reviews15 did not compare the treatment of interest to placebo. and 14. historical article. and 22) with our own de novo systematic reviews of primary. 20. and case-series studies.

18 At the request of the AAOS physician workgroup we included two surrogate outcomes.47). some studies reported short-term outcomes data on nearly all enrolled patients.18 For a surrogate outcome be valid.19 We calculated the effect size for the MCIIs for stiffness (0. functions. MINIMAL CLINICALLY IMPORTANT IMPROVEMENT Wherever possible.23) and global assessment (1.39) and function (0. we included only patient-oriented outcomes and did not include surrogate/intermediate outcomes. we did not include the longer-term data). physical function (0.21 For all calculated MCIIs. and free-floating interpositional devices) We also excluded some outcomes from consideration. and a physical component summary score (0. the visual analogue scale.. range of motion and quadriceps strength. However.20 We used data reported by Tubach et al. it must be in the causal pathway between the intervention and the outcome and it must demonstrate a large. we considered the effects of treatments in terms of the minimal clinically important improvement (MCII) in addition to whether their effects were statistically significant.• • • Was published in or after 1980 (older studies may not reflect current medical practice in OA Knee or pharmacology) Was not a retrospective chart review. arthroscopy.39) and the overall value (0. We used the effect sizes reported by Angst et al. In such cases. for the MCII for pain (0.37) for the WOMAC instrument.40) for the WOMAC instrument from the data reported by Angst et al.g. we standardized the effect size for an instrument by dividing the reported minimal clinically important difference between baseline and follow-up scores by the standard deviation of the mean baseline score.26). to calculate the effect size for the MCIIs of the Visual Analog Scale (VAS) for pain (1. and reported longer-term data on only a few patients. 6 .19 We also used data from the same group to calculate the effect size for the MCIIs of the Short Form-36 (SF-36) for bodily pain (0. we considered these two outcomes only if all other study inclusion criteria were met and only if the study reported these surrogate outcome measures in conjunction with a patient-oriented outcome. and recognizes the fact that there are some treatment-induced statistically significant improvements that are too small to matter to patients.0). For outcomes measured using “paper and pencil” instruments (e. The MCII is the smallest clinical change that is important to patients. The values we used for MCIIs are derived from the published literature. osteotomy. or survives. Surrogate outcome measures are laboratory measurements or another physical sign used as substitutes for a clinically meaningful end point that measures directly how a patient feels. With two exceptions. the Western Ontario and McMaster Osteoarthritis Index or WOMAC) we considered only results obtained using validated instruments. We only considered an outcome if ≥80% of the patients were followed for that outcome (for example. Was prospective (for all recommendations except those pertaining to needle lavage.17). consistently measurable association with the outcome.

(See Evidence Tables 1-5 in the separate Evidence Table document that accompanies this guideline and evidence report. Where possible. 14 considered the MCII in data that addressed AAOS recommendation 14. the search strategies we used are provided in Appendix IV. 2008. and did not consider MCII in data that addressed AAOS recommendations 1. The OARSI guidelines 13. 3. A list of potentially relevant studies was also provided by the workgroup members.) 7 . We also searched the bibliographies of recent review articles for potentially relevant citations. we added the MCII to the data reported in the OARSI guidelines and included it for consideration by the workgroup. 2. We searched the following databases for these reviews: • • The Cochrane Database of Systematic Reviews (through February 22.22 The associated descriptive terms we use in this guideline and the conditions for using each of these terms. but did not provide a quantitative definition of the MCII in data that addressed AAOS recommendations 11 and 13. All literature searches were supplemented with manual screening of bibliographies of all publications retrieved. We included seven systematic reviews that considered thirty-four unique randomized controlled trials. 2008) PubMed (through February 22.The AHRQ report 12 that we used to address some recommendations also considered the MCII. and 4. SEARCH FOR EXISTING SYSTEMATIC REVIEWS The workgroup chose to use systematic reviews (rather than primary studies) to provide evidence and support when such reviews were available. and a list of included systematic reviews can be found in the evidence tables. No such articles were included inasmuch as none met our inclusion criteria. Search strategies were reviewed by the workgroup prior to conducting the searches. are outlined in the following table: Descriptive Term Condition for Use Clinically Important Possibly Clinically Important Not Clinically Important Negative Inconclusive Statistically significant and lower confidence limit > MCII Statistically significant and confidence intervals contain the MCII Statistically significant and upper confidence limit < MCII Not statistically significant and upper confidence limit < MCII Not statistically significant but confidence intervals contain the MCII LITERATURE SEARCHES We searched for articles published up to February 22. 2008) The study attrition diagram in Appendix III provides details about the inclusion and exclusion of these reviews. We describe the results of studies and systematic reviews using terminology based on that of Armitage et al.

These were searches for literature on acupuncture. In the absence of relevant RCTs. The downgrading of the formal level of evidence of a study indicates the discrepancy between claims of the study authors and the results of the critical appraisal process. The study attrition diagram in Appendix III provides details about the inclusion and exclusion of these studies. caregivers. did all patients have an equal probability of being assigned to any given group) Was there concealment of the allocation to groups? Were the patients. but the level of evidence was reduced by one level if there was a “No” or “Not Reported by Authors” to any of the following checklist items: • • • Was randomization stochastic? (i. we did not search for or include lower level evidence unless there was only one higher level study. and a list of included studies can be found in the evidence tables. We conducted five recommendation-specific searches for primary articles. arthroscopy.24 DATA EXTRACTION Data elements extracted from studies were defined in consultation with the physician workgroup. If a study had more than one of the methodological flaws listed above it would only decrease by a single level. we modified the search strategy to identify studies of other designs. Retrospective comparative studies and case-control studies were initially categorized as Level III studies and case-series studies/reports were categorized as Level IV studies. and freefloating interpositional devices. needle lavage.SEARCH FOR RCTS AND OTHER STUDY DESIGNS To identify primary studies for this guideline. We used the AMSTAR tool with additional criteria (Appendix VI) to rate the quality of systematic reviews. randomized controlled trials were initially categorized as Level I studies. at the time of assignment to groups. 8 . Typically. the search strategies we used are provided in Appendix IV. and CINAHL.e. JUDGING THE QUALITY OF EVIDENCE The quality of evidence was rated using an evidence hierarchy and an accompanying checklist for RCTs. we searched three electronic databases. This evidence hierarchy is shown in Appendix V. Thirty-seven primary studies were included and ninety-two studies were excluded. Six reviewers completed data extraction independently for all studies. If higher level evidence was available. EMBASE. non-randomized controlled trials and other prospective comparative studies were initially categorized as Level II studies. According to the AAOS Levels of Evidence. PubMed. osteotomy. We used a previously published search strategy 23 to identify relevant randomized controlled trials. We sequentially searched for studies of other designs according to their level of evidence. or evaluators blinded? Downgrading of Level I studies was not cumulative.

Guideline Language Grade of Recommendation Level of Evidence We recommend We suggest option We are unable to recommend for or against A B C I Level I Level II or III Level IV or V None or Conflicting 9 . each guideline recommendation was assigned a grade that was based on the total body of evidence available using the following system: A: Good evidence (Level I Studies with consistent finding) for or against recommending intervention. The elements extracted are shown in Appendix VII . who took into account only the quality of the available evidence. GRADING THE RECOMMENDATIONS Following data extraction and analyses.25 We present details of this technique in Appendix IX. Each recommendation was constructed using the following language which takes into account the final grade of recommendation. B: Fair evidence (Level II or III Studies with consistent findings) for or against recommending intervention. Evidence tables were constructed to summarize the best evidence pertaining to each simulated recommendation.Disagreements were resolved by consensus and by consulting the workgroup. I: There is insufficient or conflicting evidence not allowing a recommendation for or against intervention. Workgroup members then modified the grade using the ‘Form for Assigning Grade of Recommendation (Interventions)’ shown in Appendix VIII CONSENSUS DEVELOPMENT The recommendations and their grades of recommendation were voted on using a structured voting technique known as the nominal group technique. Final grades were based upon preliminary grades assigned by AAOS staff. C: Poor quality evidence (Level IV or V) for or against recommending intervention.

the physician members of the AAOS Guidelines and Technology Oversight Committee and the Evidence Based Practice Committee also provided peer review of the draft document. we used the baseline standard deviations and estimated the means from the mean change from baseline scores. PUBLIC COMMENTARY After modifying the draft in response to peer review.000 iterations. Jones. the guideline was subjected to a twenty-one day period of “Public Commentary. Based on these bodies. and the AAOS Board of 10 . Texas) and the “metan” command. In addition. the final guideline draft was approved by the AAOS Guidelines Oversight Committee. We used STATA 10. Mundelein.31. Texas) and the “metareg” command to perform these computations. range. members of the Board of Councilors (BOC). THE AAOS GUIDELINE APPROVAL PROCESS Following peer review.29 we imputed the standard deviation according to a published method. College Station. For one study concerning acupuncture. and Technology. and size of the trial. The disposition of all noneditorial peer review comments was documented and accompanied this guideline through the public commentary and the following approval process. Meta-regression was used in the analysis of studies concerning acupuncture. and Technology (CORQAT). Of these.27 Heterogeneity was assessed with the I-squared statistic.28 All meta-analyses and effect size calculations were performed using STATA 10. Peer review was accomplished using a structured peer review form.26 We performed meta-analyses using the random effects method of DerSimonian and Laird. College Station. 33 requested to review the document and 4 returned public comments.30 For two additional studies concerning acupuncture. Quality Assessment. Regression analyses were performed using the permutation method of Higgins and Thompson 28 with 10. 32 PEER REVIEW The draft of the guideline and evidence report were peer reviewed for content by an expert outside advisory panel that was nominated by the physician work group a priori to the development of the guideline.0 (StataCorp LP. we estimated their means and variances according to a published method.0 (StataCorp LP. (Appendix X) The draft guideline was sent to a total of 31 reviewers and 10 returned reviews. We used the program TechDig 2.0 (Ronald B. the AAOS Evidence Based Practice Committee. up to 187 commentators had the opportunity to provide input into this guideline development process. and members of the Board of Specialty Societies (BOS).” Commentators consist of members of the AAOS Board of Directors (BOD). members of the Council on Research. the AAOS Council on Research.STATISTICAL METHODS When published studies only reported the median. Illinois) to estimate means and variances from studies presenting data only in graphical form. Quality Assessment.

genetic diagnosis. rapidly emerging treatment options. changing medical reimbursement practices by all payors and the high level of interest in this topic. Linkage to other disorders.Directors. 11 . and new evidence. the guideline will be revised in accordance with changing practice. new technology. and occupational and human factors literature will contribute to our understanding of the early stages of OA of the knee and the means of differential treatment. more objective assessments. REVISION PLANS This guideline represents a cross-sectional view of current treatment and will become outdated when more sophisticated tests. It is anticipated that this guideline will be revised in 2012. Because of the aging population. Descriptions of these bodies and dates of approval are provided in Appendix II. and more rigorous differential diagnoses are possible.

III. RECOMMENDATIONS AND SUPPORTING DATA 12 .

such as those conducted by the Arthritis Foundation. it is possible that when distributed throughout a population.02. OARSI also reports that it was not possible to assess which specific aspects of selfmanagement programs were the most effective. Although the effect is not large.RECOMMENDATION 1 We suggest patients with symptomatic OA of the knee be encouraged to participate in self-management educational programs. 14 We evaluated this evidence as Level II. 13 . AAOS Level of Evidence: Level II AAOS Grade of Recommendation: B Rationale: The OARSI guidelines. Supporting Evidence Table 1. exercise. and incorporate activity modifications (e. walking instead of running. The clinical importance of this effect cannot be determined.13. control d = standard mean difference ES = effect size MCII = minimal clinically important improvement ? = cannot be determined/unknown ? * Outcome measure is not defined by OARSI guidelines.10) vs. Summary of Evidence from OARSI for Self-Management Outcomes Pain relief* Comparison ES (95% CI) MCII Self-management d = 0.14 making it difficult to recommend a specific program. 0. on which this recommendation is based. and lifestyle modification) on patients with symptomatic OA of the knee. provide evidence from a single meta-analysis in regards to providing patient education and the impact of various self-management techniques (including changes in activity. many patients might benefit from self-management. This evidence shows that self management results in a statistically significant improvement in pain. Enhancing this recommendation is that self-management is low cost and has few associated harms.06 (0. alternative activities) into their lifestyle.g.

The AAOS workgroup initially considered the RCT evidence as a higher level but downgraded the evidence to Level IV because the results that are relevant to this recommendation are from a post-hoc subgroup analysis. AAOS Level of Evidence: Level IV AAOS Grade of Recommendation: C Rationale: The OARSI guidelines. Summary of Evidence from OARSI for Regular Telephone Contact Outcomes Pain (AIMS) Comparison ES MCII Telephone contact vs. on which this recommendation is based. provide evidence from a single RCT about the regular contact of patients with symptomatic OA of the knee. Supporting Evidence Table 2.13. Self-care is not defined in the OARSI document. 14 The evidence from OARSI suggests this contact could be from lay personnel. The clinical significance of this finding cannot be determined because the MCII for the AIMS instrument (Arthritis Impact Measurement Scale) is unknown. The results of this subgroup analysis suggest that regular telephone contact significantly reduces the amount of pain experienced by patients.65 (p<0.01) control d = standard mean difference ES = effect size NR = Not reported MCII = minimal clinically important improvement ? = cannot be determined/unknown ? * Outcome measure is not defined by OARSI.RECOMMENDATION 2 Regular contact to promote self-care is an option for patients with symptomatic OA of the knee.13. The fact that telephone contact is of relatively low cost and has minimal (if any) associated harms supports this recommendation. d = 0. 14 The evidence was evaluated as Level IV. 14 .

80. MCII = 0. Supporting this recommendation is that weight loss results in a possibly clinically important and statistically significant effect for functional improvement measured by the WOMAC function subscale (0. although the effect is statistically significant (0. 95% CI -0.13. 14 The effects of weight loss on other. 14 However. relevant outcomes are less clear. 95% CI 0. 1. the effect of weight loss on knee stiffness as measured by the WOMAC stiffness subscale is inconclusive because the effect is not statistically significant and its confidence intervals contain the MCII (0. well designed RCTs.13.12.13. 0.39). on which this recommendation is based. AAOS Level of Evidence: I AAOS Grade of Recommendation: A Rationale: The OARSI guidelines. the results of studies that used the WOMAC to measure pain relief are negative because the MCII lies above the confidence intervals and the effect is not statistically significant (0. 14 we cannot conclude that the effect is not clinically important Similarly. 14 This evidence was evaluated as Level I because of the relevant studies were considered high quality.38.08. although weight loss has a statistically significant effect on physical disability (0.13. 95% CI 0. 0.23.69. 95% CI -0.42).13. MCII = 0.20. The effects of weight loss on pain cannot be determined because of uncertainties in the way pain was measured in the unique. provide evidence from two RCTs and a recent systematic review regarding the role of weight loss in patients with symptomatic OA of the knee. should be encouraged to lose weight (a minimum of five percent (5%) of body weight) and maintain their weight at a lower level with an appropriate program of dietary modification and exercise.39).13. who are overweight (as defined by a BMI>25). other studies reported in the OARSI guideline used an indeterminate method of measuring pain (making it impossible to know the MCII) and. 0.14. Finally. the effect of weight loss on functional improvement combined with the fact that weight loss is likely to have health benefits that extend beyond OA of the knee argue for this recommendation.13.24.39). 14 However.04.RECOMMENDATION 3 We recommend patients with symptomatic OA of the knee. Accordingly. MCII = 0.37).36. 14 the clinical importance of this effect cannot be determined because the MCII is unknown. Supporting Evidence Table 3 (see next page) 15 . 95% CI 0. 0. relevant primary studies considered in the OARSI guideline.

08. ? ? 16 . 0.23 (0.36 (-0.37 Weight loss diet d = 0. control Functional improvement Weight loss diet d = 0.42) vs.Table 3.69 (0.24.14) (WOMAC) vs.39 0.20 (0. control Weight loss diet Pain* d = 0.39 0. Summary of Evidence from OARSI for Weight Loss Outcomes Pain relief (WOMAC) Comparison ES (95% CI) MCII 0. control Weight loss diet Stiffness (WOMAC) d = 0. 1. 0. control d = standard mean difference ES = effect size MCII = minimal clinically important improvement ? = cannot be determined/unknown * Outcome measure is not defined by OARSI.12.38) vs.39) vs. control Weight loss diet Physical disability* d = 0. 0.13 (-0.80) vs.04. 0.

the relatively low cost and likely additional health benefits of exercise support this recommendation.34.13.25. control Aerobic exercises vs.52. Summary of Evidence from OARSI for Aerobic Exercise Outcomes Pain relief* Disability* Comparison Aerobic exercises vs. control ES (95% CI) d = 0.46. 17 . 95% CI 0.67)13. 95% CI 0.67) MCII ? ? d = standard mean difference ES = effect size MCII = minimal clinically important improvement ? = cannot be determined/unknown * Outcome measure is not defined by OARSI. Although the clinical importance of these effects cannot be determined. provide evidence from a systematic review that included 13 randomized controlled trials on aerobic exercises (such as walking or cycling) in patients with OA of the knee. AAOS Level of Evidence: I AAOS Grade of Recommendation: A Rationale: The OARSI guidelines on which this recommendation is based. 14 This recommendation was addressed by a systematic review of well-designed RCTs.34. 0. Supporting Evidence Table 4.70) d = 0. 14 are statistically significant. 0. making the evidence Level I.70) and disability (0.46 (0.25.RECOMMENDATION 4 We recommend patients with symptomatic OA of the knee be encouraged to participate in low-impact aerobic fitness exercises. The effects of aerobic exercises on pain relief (0. 0. 0.52 (0.

RECOMMENDATION 5 Range of motion/flexibility exercises are an option for patients with symptomatic OA of the knee. and their potential benefits warrant this recommendation. AAOS Level of Evidence: V AAOS Grade of Recommendation: C Rationale: Individuals with OA of the knee often suffer from joint stiffness and may have loss of joint motion and limited muscle flexibility. We were unable to find any published studies that addressed the effects of motion/flexibility exercises in patients with OA of the knee. The consensus of the AAOS workgroup is that range of motion and flexibility exercises are an option to address these impairments. which is Level V evidence. The low cost of these exercises. this recommendation is based on expert opinion. 18 . the limited harms associated with them. Supporting Evidence We used expert opinion to support this recommendation. Therefore. No studies investigating the use of range of motion or flexibility exercises were identified by our systematic literature searches.

the results of this meta-analysis are difficult to interpret because of the presence of significant heterogeneity. like that of our analysis on pain. there was no heterogeneity and the effect. The systematic review concludes that quadriceps strengthening is effective. due to the presence of heterogeneity. therefore. Therefore. found a statistically significant effect. the results of this meta-analysis are difficult to interpret. We therefore conducted a subsequent meta-analysis of change scores and. However. but it is difficult to also conclude that they are not clinically important. When we omitted a single outlying trial (which found an unusually large effect) from the meta-analysis. The same systematic review33 that reported a statistically significant effect on pain also reports that quadriceps strengthening improves function by a statistically significant degree. although statistically significant. Again. we conducted a de novo meta-analysis of only those studies that measured function using the WOMAC function subscale and included one RCT44 not in the systematic review. The major shortcoming of this analysis was that it combined studies that measured pain in different ways. This is because removal of a study from a meta-analysis simply because it is a statistical outlier is an ad hoc procedure. 19 . again. The evidence is Level II because not all of the included RCTs were high quality. However. This latter analysis strongly suggests that the effects of quadriceps strengthening on pain are statistically significant. suggest a statistically significant and possibly clinically important effect. AAOS Level of Evidence: II AAOS Grade of Recommendation: B Rationale: This recommendation was addressed by one Level II systematic review33 that included nine RCTs that examined the effects of quadriceps strengthening on pain34-42 and 10 RCTs34-43 examined the effect of quadriceps strengthening on function. The results of this meta-analysis. do not cause us to conclude that quadriceps strengthening is ineffective. it was not possible to determine whether this effect was clinically important. the evidence is sufficient to suggest the use of quadriceps strengthening. and in light of the lack of harms associated with quadriceps strengthening. Therefore. was not clinically important. These analysis included an RCT44 not included in the systematic review. we performed our own meta-analysis of just those studies that used the WOMAC pain subscale. However. In light of this. The systematic review33 that addressed this recommendation contained a meta-analysis that found that the effects of quadriceps strengthening on pain were statistically significant. We supplemented the systematic review by performing our own meta-analyses. we were unable to confirm the clinical importance of quadriceps strengthening. these results do no obviate the effects of quadriceps strengthening on pain and. Nevertheless. well designed trials.RECOMMENDATION 6 We suggest quadriceps strengthening for patients with symptomatic OA of the knee. making it impossible to determine whether the effects were clinically important. The results of this analysis suggest that quadriceps strengthening reduces pain by a statistically significant degree and is possibly clinically important. due to the fact that the meta-analysis combined studies that used different scales.

42 For the raw data addressing this recommendation. seven studies used the WOMAC Function subscale. 43 two used the Dutch version of AIMS.34-38. To measure pain. Figures relevant to this recommendation are Figure 1 .34-38 three used the Visual Analogue Scale (VAS).Supporting Evidence The studies that addressed this recommendation ranged in duration from 8 weeks to 24 months. 20 . varied in their control group (no intervention or education). Relevant study attrition diagram shown in Appendix III. 41.42 To measure function. whether the programs were home-based or supervised.39. five studies in the systematic review used the WOMAC Pain subscale. 40 and one used a physical disability questionnaire developed for the Fitness Arthritis and Seniors Trial (FAST). and used a variety of outcome measures.39-41 and one used the Knee Pain Scale.Figure 6. please see evidence tables: 6-7.

equivocal because we were unable to discover why the study was an outlier.4%). 95% CI 0. and the control group received a sham exercise program 21 . we conducted a second meta-analysis (Figure 3) that omitted this trial. The first of these analyses (Figure 2) revealed a statistically significant and possibly clinically important effect (0.32 (0.23. 0. 0. This analysis includes one RCT 44 not included in the systematic review. and its results suggest that the effect of quadriceps strengthening is statistically significant but not clinically important (0. this analysis was heterogeneous (I2 = 65. we conducted our own meta-analyses (using a random effects model) of just those studies that reported pain on the WOMAC pain subscale.37).16. The results of this meta-analysis are. the clinical importance of this effect cannot be determined.15. making the summary results difficult to interpret. 0. Consequently. 0. all participants in this study were prescribed an NSAID. 95% CI 0.42) Favors Control N=2004 from 9 RCT 0 . Figure 1. Pain (systematic review Roddy et al. nevertheless.2 years 0. Therefore.37.8 Favors Strengthening * 10th study 43 excluded from pain meta-analysis to reduce heterogeneity. The heterogeneity was due to the results of one trial 43 that found an unusually large effect and was a statistical outlier. 2005) Outcome Duration SMD (95% CI) Pain 8 weeks .42) of quadriceps strengthening on pain (Figure 1) but.26.2 .5 . However. 95% CI 0.32.0%).23. The analysis was not heterogeneous (I2 = 0. Omitting a study simply because it is an outlier is ad hoc.59).PAIN Level of Evidence: One Level II Systematic Review and one additional Level II RCT A meta-analysis conducted in the systematic review found a statistically significant effect (0. because it combined different pain scales.

0.59) Overall (I-squared = 65.35 (-0.09.38) 0.02 (-0.56 (-0.27 (-0.67) 0.56 (-0. 0.12.12. 0.38) 0.72) 0.03. AAOS Analysis: WOMAC Pain Excluding Petrella RCT Study Duration SMD (95% CI) Maurer 1999 Fransen 2001 8 weeks 8 weeks 0.97 (0. 0.02 (-0.37) Topp 2002 (iso) 16 weeks Topp 2002 (dyn) 16 weeks Baker 2001 O'Reilly 1999 Thomas 2002 4 months 6 months 24 months Overall (I-squared = 0. 0.46.66. 1.04. 0. 0. AAOS Analysis: WOMAC Pain Study Duration SMD (95% CI) Petrella 2000 Maurer 1999 Fransen 2001 Topp 2002 (iso) Topp 2002 (dyn) Baker 2001 O'Reilly 1999 Thomas 2002 8 weeks 8 weeks 8 weeks 16 weeks 16 weeks 4 months 6 months 24 months 0.5 .61) 0.67) 0.37 (0.27 (-0. 0.55.35 (-0.881) Favors Control 0 .5 .23 (0. 1.59) 0.15.09.8 Favors Strengthening *Longer Dashed line indicates MCII for WOMAC Pain **Diamond represents summary statistic and associated 95% confidence interval ***SMD: standardized mean difference Figure 3.32 (0.39. 0.03. 1.55.17) 0.39. 0.03.0%.04.12 (-0.03. 0.46.59) 0.28) 0. p = 0.2 .4%.23 (0.2 .70) 0.16.17) 0.Figure 2.70) 0.32 (0. 0. 0.005) NOTE: Weights are from random effects analysis Favors Control 0 .72) 0. p = 0.8 Favors Strengthening *Longer dashed line indicates MCII for WOMAC Pain 22 . 0.61) 0.26 (0.12 (-0.

although statistically significant.32.39. This heterogeneity was due to one study. we conducted a random effects meta-analysis of all quadriceps strengthening RCTs that utilized the WOMAC function subscale. This is a conservative assumption that will artificially widen the confidence intervals around the summary statistic. there was a statistically significant difference between the treatment and control groups in function at baseline.0. The analysis exhibited no meaningful heterogeneity (I2 = 3.29. Because of this. 95% CI 0. Our analysis includes one RCT 44 not included in the systematic review. Neither quantity was published in the available studies. Figure 5 displays the results of this analysis. and shows that the effect was statistically significant and possibly clinically important (0.1%).and post-test scores is known. In an attempt to account for this difference.43 In this study.23. To determine the clinical importance of quadriceps strengthening. we performed a metaanalysis of change scores. 0.41) effect of quadriceps strengthening on function but combined multiple scales to measure the effect of quadriceps strengthening on disability.7%) and suggests that. we can conclude that the effect of quadriceps strengthening on function in patients with OA of the knee is not clinically important. 23 . 95% CI 0. the results are not clinically important. Of note is that one can only accurately estimate the confidence intervals around change scores when the raw data are presented in all relevant articles or when the correlation between pre. Because the MCII lies above these conservative confidence intervals. the clinical importance of this effect again cannot be determined (Figure 4).FUNCTION Level of Evidence: One Level II Systematic Review and one Level II RCT The systematic review that addressed this recommendation found a statistically significant (0. but it is difficult to interpret this summary statistic because of the presence of heterogeneity ( I2 = 91. so we used the baseline standard deviation as a measure of the change score dispersion.50). Figure 6 depicts the results of this analysis.

83) 0.11.07.5 .8 Favors Control Favors Strengthening *Petrella RCT: baseline difference in the outcome measure between the treatment and control groups ** Dashed line indicates MCII for WOMAC Function 24 .09) 0. 0.8 Favors Strengthening Figure 5.58) 0.000) 0 .50) Overall (I-squared = 91.21.39) 0.2 years 0.34 (-0.29 (0. 0. 0.80) 0. 1. 0.2 .55.18 (-0. 2005) Outcome Duration SMD (95% CI) Function 8 weeks .1%.58) -0. 0.32 (0.5 .38) 0. 0.10.37 . p = 0. 0.00.30) 0.24 (0.Figure 4.39 (0.41) Favors Control N=2004 from 10 RCT 0 .66.05. 0.42 (0. Function (systematic review Roddy et al.2.14. 2.23.88) 0.29. 0.41 (-0.12 (-0.49 (-0.02 (1. AAOS Analysis: WOMAC Function Study Duration SMD (95% CI) Petrella 2000 Maurer 1999 Fransen 2001 Topp 2002 (iso) Topp 2002 (dyn) Baker 2001 O'Reilly 1999 Quilty 2003 Thomas 2002 8 weeks 8 weeks 8 weeks 16 weeks 16 weeks 4 months 6 months 12 months 24 months 2.

0.50 (-0.37.80) 0. 0. 1.39 (0.59) -0.07 (-0. 0.5 Favors Strengthening *Longer dashed line indicates MCII for WOMAC Function 25 .47.39) 0. p = 0. 0.10) 0. 0.29 (-0.Figure 6.8 0 .14. AAOS Analysis: WOMAC Function Using Change Scores Study Duration SMD (95% CI) Petrella Maurer Fransen Topp(iso) 8 weeks 8 weeks 8 weeks 16 weeks 0.00.27) 0.33) 0. 0. 1.24 (0.7%.15 (-0.29 (-0.12) 0.34) Topp(dyn) 16 weeks Baker O'Reilly Quilty Thomas 4 months 6 months 12 months 24 months Overall (I-squared = 3. 0.02.24 (0.01.38.59) -0.54 (-0.76) 0.03. 0.404) Favors Control .2 .10.57.21 (-0.10.

One study47 also investigated taping to apply a laterally directed force. Supporting Evidence For the raw data addressing this recommendation. Analysis of evidence in the systematic review does not suggest that lateral taping is effective. but this effect is only observed when taping is compared to no taping. All three studies investigated taping to apply a medially directed force compared to sham taping and no taping. The systematic review concludes that medially directed taping produces a clinically meaningful change in chronic anterior knee pain or pain due to OA of the knee. The RCTs in the systematic review report statistically significant and possibly clinically important effects of medial taping on pain (as measured by the visual analogue scale) immediately and four days after the start of taping. 26 .RECOMMENDATION 7 We suggest patients with symptomatic OA of the knee use patellar taping for short term relief of pain and improvement in function. and that there is insufficient evidence to determine the effectiveness of lateral taping. 48 The Level II RCTs did not conceal the allocation to groups. There is some evidence that medial taping reduces pain on movement by an amount that is possibly clinically important. and not when medial taping is compared to a sham.Figure 9. please see evidence tables: 8-9. AAOS Level of Evidence: II AAOS Grade of Recommendation: B Rationale: One Level II Systematic Review45 examined the use of patellar taping among patients with symptomatic OA of the knee. Figures relevant to this recommendation are Figure 7 . The review included one Level I RCT46 and two Level II RCTs. Relevant study attrition diagram shown in Appendix III.47.

LATERALLY-DIRECTED TAPING Level of Evidence: One Level II Systematic Review Figure 7 presents the effects of laterally-directed taping on pain measured by VAS.23 Favors Lateral *Dashed line indicates MCII for VAS Pain 27 .8 1. 2008) Study Outcome Duration SMD (95% CI) Cushnaghan 1994 VAS Pain 4 days -0.5 .2 . Sham Taping – Pain: VAS (systematic review Warden et al. The results are negative inasmuch as the effect is neither statistically significant nor clinically important Figure 7. Lateral vs.57.PAIN: VISUAL ANALOG SCALE (VAS) . 0.05 (-0.48) Favors Sham 0 .

PAIN: VAS . Medial vs. the effect of medially-directed taping is statistically significant and possibly clinically important immediately. When the comparison group is sham taping.47) Cushnaghan 1994 VAS Pain 4 days 0.94 (0.47) Hinman 2003b VAS Pain on Movement 3 weeks 0. and three weeks after taping.23. Sham Taping – Pain:VAS (systematic review Warden et al. sham and no taping. The effect is neither statistically significant nor clinically important three weeks after taping.42. 1.21 which corresponds to a SMD of 1.35 (-0.8 1.MEDIALLY-DIRECTED TAPING Level of Evidence: One Level II Systematic Review Figure 8 and Figure 9 present the effects of medially-directed taping on pain measured by VAS vs. 1. 2008) Study Outcome Duration SMD (95% CI) Hinman 2003a VAS Pain while Walking Immediate 0.73) Favors Sham 0 .91 (0.03.9 mm. Figure 8.2 . 0. When the comparison group is no taping (which is not as satisfactory of a control group as sham taping). The MCII for VAS Pain is 19.23 Favors Medial *Dashed line indicates MCII for VAS Pain 28 .34.5 . the effect of medially-directed taping is statistically significant and possibly clinically important immediately and four days after taping. respectively.

08 (0.64) Favors No Tape 0 .23 Favors Medial *Dashed line indicates MCII for VAS Pain 29 .Figure 9.22 (0. 1. No Taping – Pain: VAS (systematic review Warden et al.51.64) Hinman 2003b VAS Pain on Movement 3 weeks 1. Medial vs. 2008) Study Outcome Duration SMD (95% CI) Hinman 2003a VAS Pain while Walking Immediate 1. 1.8 1.2 .5 .80.

RECOMMENDATION 8
We suggest lateral heel wedges not be prescribed for patients with symptomatic medial compartmental OA of the knee. AAOS Level of Evidence: II AAOS Grade of Recommendation: B Rationale: This recommendation is addressed by one Level II Systematic Review49 of three Level II RCTs that examined the use of lateral heel wedges among patients with symptomatic medial compartmental OA of the knee The three Level II RCTs were published in six separate articles.50-55 Comparisons between lateral heel wedges and neutral heel wedges are investigated as well as comparisons between lateral wedged insoles and lateral wedged insoles with subtalar strapping. The systematic review concludes that there is only limited evidence for the effectiveness of lateral heel wedges and related orthoses. The systematic review provides no evidence that lateral heel wedges are more effective than neutral heel wedges, when assessed with the WOMAC instrument for up to 24 months. The effects of lateral heel wedges on WOMAC function and stiffness are all statistically non-significant and trend in favor of the control group, and the all but one of the effects on WOMAC pain are statistically non-significant and similarly trend in favor of the control. The only statistically significant effect on WOMAC pain (at 6 months) again favors the control group (although the effect was not clinically important; Figure 10). No statistically significant effects of lateral heel wedges on patient global assessment (Figure 11) or analgesic intake (Figure 12) were found. The systematic review provides no evidence that lateral heel wedges are more effective than subtalar strapped insoles when assessed by patient oriented outcome measures. Indeed, at 8 and 24 months, there were statistically significant effects on pain (as measured by the visual analogue scale) in favor of subtalar strapped insoles (the effect was not significant at 24 months; Figure 13). Statistically significant effects favoring strapped insoles were also found for the Lequesne index at 8 weeks and 12 months (but not at 24 months; Figure 14). The effects on pain were not clinically important, and the MCII is not known for the other outcomes. These data suggest that there is no benefit to using lateral heel wedges, and there is the possibility that those who do not use them may experience fewer OA of the knee symptoms. Supporting Evidence For the raw data addressing this recommendation, please see evidence tables: 10-11. Figures relevant to this recommendation are Figure 10 - Figure 16. Relevant study attrition diagram shown in Appendix III.

30

Figure 10 - Figure 12 display the results comparing lateral heel wedges to neutral heel wedges. WESTERN ONTARIO MCMASTER QUESTIONNAIRE (WOMAC) Level of Evidence: One Level II Systematic Review Figure 10. Lateral vs. Neutral Heel Wedge – WOMAC (systematic review Brouwer et al. 2008)
N, mean Outcome Duration Maillefert et al. 2001 WOMAC pain 1 month 3 months 6 months 12 months 24 months WOMAC function 1 month 3 months 6 months 12 months 24 months WOMAC stiffness 1 month 3 months 6 months 12 months 24 months -0.24 (-0.55, 0.08) 74, 48.5 (23) -0.20 (-0.51, 0.12) 74, 48.8 (18) -0.19 (-0.50, 0.13) 74, 47.1 (22) 0.05 (-0.27, 0.36) 74, 50 (18.9) -0.08 (-0.39, 0.24) 74, 50 (19.7) 82, 54 (23) 82, 53 (24) 82, 51.4 (24) 82, 48.9 (27.5) 82, 51.8 (27.3) -0.14 (-0.46, 0.17) 74, 49 (19) -0.27 (-0.59, 0.04) 74, 47.2 (18) -0.30 (-0.62, 0.02) 74, 47.3 (20) 0.02 (-0.30, 0.33) 82, 51.6 (18) 82, 52.4 (20) 82, 53.3 (20) -0.28 (-0.60, 0.04) 74, 48.9 (18) -0.24 (-0.55, 0.08) 74, 48.5 (23) -0.32 (-0.63, -0.00) 74, 46.4 (18) 82, 54.1 (19) 82, 54 (23) 82, 52.8 (22) SMD (95% CI) (SD); Neutral N, mean (SD); Lateral

-0.10 (-0.41, 0.22) 74, 47.9 (19.4) 82, 50.1 (24.8) -0.12 (-0.43, 0.20) 74, 48.2 (19.9) 82, 51 (26.7)

-0.03 (-0.34, 0.29) 74, 48.4 (19.2) 82, 49 (24.7) 74, 50.4 (21.1) 82, 50 (26.4)

-.8

-.5 -.2 Favors Neutral

0

.2 .37 .5 Favors Lateral

.8

*Dashed line indicates MCII for WOMAC Function (0.37); MCII for Pain/Stiffness = 0.39

31

PATIENT GLOBAL ASSESSMENT Level of Evidence: One Level II Systematic Review Figure 11. Lateral vs. Neutral Heel Wedge - Patient Global Assessment (systematic review Brouwer et al. 2008)
N, mean N, mean

Outcome

Duration

SMD (95% CI)

(SD); Neutral

(SD); Lateral

Patient Global Assessment

24 months

-0.07 (-0.38, 0.25)

74, 55.1 (21.1)

82, 56.7 (26.1)

0 .2 .5 .8 Favors Neutral Favors Lateral

32

MEDICATION INTAKE Level of Evidence: One Level II Systematic Review Figure 12. Lateral vs. Neutral Heel Wedge - Medication Intake (systematic review Brouwer et al. 2008)
N, mean N, mean

Outcome

Duration

SMD (95% CI)

(SD); Neutral

(SD); Lateral

Analgesic intake

3 months

0.19 (-0.13, 0.50)

74, 15 (28)

82, 9.9 (27)

NSAID intake

3 months

0.06 (-0.26, 0.37)

74, 22.4 (32)

82, 20.5 (33)

0 Favors Neutral

.2 .5 .8 Favors Lateral

33

Figure 13 - Figure 16 display the results comparing inserted lateral wedged insoles to lateral wedged insoles with subtalar strapping. PAIN: VAS Level of Evidence: One Level II Systematic Review Figure 13. Traditional Inserted vs. Subtalar Strapped Insoles – Pain: VAS (systematic review Brouwer et al. 2008)
N, mean Outcome Duration SMD (95% CI) (SD); Strapped N, mean (SD); Inserted

VAS pain 8 weeks 6 months 24 months -0.42 (-0.84, -0.00) -0.58 (-1.00, -0.16) -0.11 (-0.52, 0.31) 46, 34.6 (21.3) 46, 32.7 (20.7) 46, 39.6 (18.7) 44, 43.8 (22.6) 44, 44.5 (20) 44, 41.6 (18.8)

-1.23 -.8 -.5 -.2 0 .2 .5 .8 Favors Strapped Favors Inserted

*Dashed line indicates MCII for VAS Pain

34

8) -. Strapped (SD).33 (-0.1 (5. .3) 44.44 (-0.8 -.2 0 .14) -0. Subtalar Strapped Insole .8 (5.2 (5. 9.09) 42.8 Favors Strapped Favors Inserted Figure 15.6) 44. 9.75.Lequesne Index (systematic review Brouwer et al.4) -. 2008) SMD (95% N.5 . 0.2 .6 (4.LEQUESNE INDEX Level of Evidence: One Level II Systematic Review Figure 14. Subtalar Strapped Insoles .86. Sock-type Inserted vs. 2008) N. 7.30) -0..02) 46.5 (5.5 . mean (SD). Strapped N.11 (-0.53.5 -. mean Outcome Duration CI) . (. 7.4) 46. Inserted Lequesne Index 8 weeks -0.3 (5.8 Favors Strapped Favors Inserted 35 . -0.3 (5. mean Outcome Duration SMD (95% CI) (SD). mean N.28 (-0.4) 46. 9 (5) 44.69. Inserted Lequesne index 8 weeks 6 months 24 months -0.5 -. Traditional Inserted vs.8 -. 8. 0. 8.2 .) (SD).Lequesne Index (systematic review Brouwer et al. 7. 0.2 0 .8) 46.

) Strapped Inserted Adverse effects 8 weeks 5. (..74 (0. low back pain.77) 6/46 1/44 .ADVERSE EFFECTS Level of Evidence: One Level II Systematic Review Figure 16.Adverse Effects (systematic review Brouwer et al. Outcome Duration CI) . 2008) RR (95% Events. Events. Inserted vs. and foot sole pain 36 .72. . 45.1 10 1 Favors Strapped Favors Inserted *Adverse effects included popliteal pain. Subtalar Strapped Insoles .

RECOMMENDATION 9 We are unable to recommend for or against the use of a brace with a valgus directing force for patients with medial uni-compartmental OA of the knee. please see evidence tables: 12-14. The systematic review provides no evidence for improvement in pain measured by the Visual Analog Scale at 6 or 12 months. Supporting Evidence For the raw data addressing this recommendation. The systematic review concludes that there is only limited evidence for the effectiveness of knee braces.Figure 21. AAOS Level of Evidence: II AAOS Grade of Recommendation: Inconclusive Rationale: One Level II Systematic Review49 of two RCTs56. The qualitative results reported by the systematic review (for the study that did not adequately report quantitative data) indicate that patients in the brace group improved more on each outcome than patients that received either a neoprene sleeve or were in the control group. The brace is applied with the intent to alter a varus malaligned knee and move the alignment of the knee in a valgus direction. The effects are not clinically important and not statistically significant (Figure 17). One of the RCTs57 included in the systematic review presented insufficient quantitative data for analyses. See evidence tables 13 and 14 for details. Note: One57 of the two RCTs included in the systematic review presented insufficient quantitative data for data extraction. The clinical importance of the effects of a brace on Walking Distance (Figure 19) and Quality of Life (Figure 21) cannot be determined and are not statistically significant at 6 or 12 months. 37 . Relevant study attrition diagram shown in Appendix III. Figures relevant to this recommendation are Figure 17 . 57 examined the use of braces among patients with medial uni-compartmental OA of the knee.

19% had OA of the lateral compartment **Dashed line indicates MCII for VAS Pain 38 .00 (-0. 2008) Duration N.5 .23 Favors Brace *81% of the study population had OA of the medial compartment.41) 57. 49 (24) VAS pain 12 0. mean N.2 . VAS Pain (systematic review Brouwer et al. 0.05 (-0. mean Outcome (months) SMD (95% CI) (SD). Brace VAS pain 6 0.32. 52 (22) 60.36) 57.PAIN: VAS Level of Evidence: One Level II Systematic Review Figure 17. 0. 50 (20) 60.36.8 1. 52 (24) Favors No Brace 0 . No Brace (SD).

HOSPITAL FOR SPECIAL SURGERY KNEE SCORE (HSS) Level of Evidence: One Level II Systematic Review Figure 18. HSS (systematic review Brouwer et al. 2008)
Duration N, mean N, mean

Outcome

(months)

SMD (95% CI)

(SD); Brace

(SD); No Brace

HSS (function)

6

0.14 (-0.22, 0.50)

60, 70.8 (10)

57, 69.4 (10.1)

HSS (function)

12

0.09 (-0.27, 0.46)

60, 70 (10.7)

57, 69 (10.6)

-.8 -.5 -.2 0 .2 .5 .8 Favors No Brace Favors Brace

*81% of the study population had OA of the medial compartment; 19% had OA of the lateral compartmental

39

WALKING DISTANCE (KM) Level of Evidence: One Level II Systematic Review Figure 19. Walking Distance (systematic review Brouwer et al. 2008)
Duration N, mean N, mean

Outcome

(months)

SMD (95% CI)

(SD); Brace

(SD); No Brace

Walking Distance (km)

6

-0.03 (-0.39, 0.33)

60, 3.6 (2.9)

57, 3.7 (3.7)

Walking Distance (km)

12

0.11 (-0.25, 0.47)

60, 3.7 (3.6)

57, 3.3 (3.7)

-.8 -.5 -.2 0 Favors No Brace

.2 .5 Favors Brace

.8

*81% of the study population had OA of the medial compartment; 19% had OA of the lateral compartmental

Because of between-group differences at baseline in walking distance, Figure 20 presents the effect size based on differences from baseline rather than the post-treatment values presented in Figure 19. Figure 20. Walking Distance Change from Baseline (systematic review Brouwer et al. 2008)
Duration N, mean N, mean

Outcome

(months)

SMD (95% CI)

(SD); Brace

(SD); No Brace

Walking Distance (km)

12

0.49 (0.13, 0.86)

60, 1.1 (3.6)

57, -.7 (3.7)

0 .2 .5 .8 Favors No Brace Favors Brace

40

QUALITY OF LIFE Level of Evidence: One Level II Systematic Review Figure 21. Quality of Life (EQ-5D) (systematic review Brouwer et al. 2008)
Duration N, mean N, mean

Outcome

(months)

SMD (95% CI)

(SD); Brace

(SD); No Brace

Quality of Life (EQ-5D)

6

-0.21 (-0.57, 0.15)

60, .55 (.26)

57, .6 (.21)

Quality of Life (EQ-5D)

12

-0.17 (-0.54, 0.19)

60, .56 (.25)

57, .6 (.21)

-.8

-.5 -.2 0 Favors No Brace

.2 .5 Favors Brace

.8

*81% of the study population had OA of the medial compartment; 19% had OA of the lateral compartmental

41

RECOMMENDATION 10
We are unable to recommend for or against the use of a brace with a varus directing force for patients with lateral uni-compartmental OA of the knee. AAOS Level of Evidence: Level V AAOS Grade of Recommendation: Inconclusive Rationale: A knee brace, applied with the intent to alter a valgus malaligned knee and move the alignment of the knee in a varus direction, has been proposed as a treatment for individuals with symptomatic lateral tibiofemoral OA of the knee. No studies were identified by our systematic review processes, specific to patients with lateral tibiofemoral OA of the knee. Supporting Evidence No studies investigating the use of a brace with a varus directing force were identified by our systematic literature searches.

42

RECOMMENDATION 11
We are unable to recommend for or against the use of acupuncture as an adjunctive therapy for pain in patients with symptomatic OA of the knee. AAOS Level of Evidence: I and II AAOS Grade of Recommendation: Inconclusive Rationale: This recommendation is addressed by the OARSI guidelines and six Level I and eight Level II RCTs. The OARSI guideline reports conflicting evidence, from two RCTs and one systematic review, regarding the symptomatic benefit of acupuncture in patients with OA of the knee.13, 14 One RCT58 and the systematic review59 support the use of acupuncture and one RCT60 does not support the use of acupuncture. In an attempt to resolve these conflicting results, we conducted a de novo systematic review of previously published systematic reviews (Table F) and confirmed that their conclusions were conflicting. Consequently, we updated these reviews with our own, including performing a meta-analysis of results of all eligible RCTs on the use of acupuncture in patients with symptomatic OA of the knee. Our meta-analysis suggests that the reported effects of acupuncture pain depend on study design and conduct. Accordingly, the largest effects on pain (Figure 22) and on function (as measured by the WOMAC function subscale; Figure 23) are found in studies that did not employ blinding, the smallest effects are found in studies that employed blinding and verified that patients were blinded, and intermediate effects are found in studies that employed blinding but did not verify that patients were blinded. Meta-regression reveals that these relationships are statistically significant, but also reveals that these relationships do not explain all of the differences between study results (Table 7). Further analyses showed that the effects of acupuncture on pain and function were not statistically significant in studies that verified that their patients were blinded. However, there remains a large amount of unexplained variance in this group of studies as well as in the other two groups. Thus, although our meta-analytic results suggest that the apparent effects of acupuncture are due to a placebo effect, the unexplained differences among study results do not conclusively prove this point. Because of this, and because of the conflicting conclusions of previously published systematic reviews, we agreed that currently available evidence about the benefits of acupuncture is inconclusive. Supporting Evidence For the raw data addressing this recommendation, please see evidence tables: 15-17. Figures relevant to this recommendation are Figure 22 - Figure 103. Relevant study attrition diagram shown in Appendix III.

43

41 (0. sham Acupuncture Stiffness (WOMAC) d = 0.37 Acupuncture d = 0.39 0. sham d = standard mean difference ES = effect size MCII = minimal clinically important effect Table 6. Table 5. ? for MA ? Inconclusive evidence = No clinical benefit ↑ Favors acupuncture EA electro-acupuncture MA manual acupuncture 44 . sham Acupuncture Function (WOMAC) d = 0. 0.13.69) vs.51 (0.PREVIOUSLY PUBLISHED ANALYSES The results of previously published analyses on the effectiveness of acupuncture are shown in Table 5 (the OARSI guideline) and Table 6 (previously published systematic reviews. 0.23. Summary of Evidence from OARSI for Acupuncture Outcomes Pain (WOMAC) Comparison ES (95% CI) MCII 0. 0.39 0.23.79) vs.51 (0.79) vs. Conclusions of Previously Published Systematic Reviews on Acupuncture in Patients with OA of the Knee Systematic Review 61 Conclusion Puett 1994 ? Ezzo 2001 59 ↑ 62 Ferrandez 2002 ? Kwon 2006 63 ↑ 64 White 2007 ↑ Manheimer 2007 65 = Bjordal 2007 66 ↑ for EA.

29 one used pain on the Numerical Rating Scale (NRS). 32. The figures demonstrate that individual study results varied according to whether patients were blinded and whether the investigators attempted to determine that blinding was successful: studies that verified that efforts to blind patients were effective produced much smaller effects than studies that did not verify the effectiveness of patient blinding.73 and one used Present Pain Intensity to measure pain. blinding accounts for 50% and 44% of the between study variance in the pain and function models. sham or non-sham control groups.DE NOVO ANALYSIS Figure 22 presents the results of the AAOS meta-analysis of 13 RCTs examining acupuncture’s effect on pain among patients with OA of the knee vs. Figure 23 presents the results of the AAOS meta-analysis of nine RCTs31. Significant heterogeneity is present in both meta-analyses. While significant heterogeneity still remains in each model (I2 = 75%). 67-71 examining acupuncture’s effect on function among patients with OA of the knee (all nine utilized the WOMAC physical function subscale).74 Outcome durations ranged from 2-13 weeks. Ten studies used the WOMAC pain subscale.04). This association applies to both pain (p = 0. 60. 45 . There is a statistically significant association between the level of patient blinding and a study’s effect size. 58. 58.31. 60. respectively. Studies with no patient blinding found the largest effects. Outcome durations ranged from 4-13 weeks. The results of our meta-regression on the effects of blinding status are shown in Table 7.01) and function (p = 0. 67-72 one used pain on VAS. 32.

1.007) . p = 0.02.08.65 (0.82 (-0. p = 0. p = 0.33.10.13 (-0.18) 1. 0.35.15 (0. 1.15.0%.35) 0. 1.77 (1. 0. Non-Verified Blinding Vas (2004) Takeda (1994) Berman (2004) Molsberger (1994) Sangdee (2002) Yurtkuran (1999) Sangdee (2002) Subtotal (I-squared = 81.10 (-0.91) 0. NOTE: Weights are from random effects analysis 0.29.28) 0.Pain Study Verified Blinding Witt (2005) Foster (2007) Scharf (2006) Subtotal (I-squared = 79. No Blinding Tukmachi (2004) Berman (1999) Witt (2006) Ng (2003) Subtotal (I-squared = 36.23. 0.57 (0.2 . 0.52 (0.29 (-0.5 .14 (-0.40) Favors Control 46 .46 (0.16) 0. 2.47) 0.81) -0. 1.07 (0. Acupuncture vs. 1.8 Favors Acupuncture SMD (95% CI) 0.72.55 (0.000) .86) 1. 0.85) 1.196) .05.01) 2.06 (0. 0.11) 0.9%. Control . 1. 0.Figure 22. 0.18 (-0.21.96.0%.47) 1.98) 0.04 (0. 1.73. 3.12.11.65.64) 0.42) 0.62.91 (0.01) 0.

9% 47 .24 (0.4%.0% 44.58) SMD (95% CI) Favors Control . NOTE: Weights are from random effects analysis 0.26 (-0.76) 0.02 (-0. 0. 0.65.36.9%.011) . 0.17 (0.88) 0.2. No Blinding Witt (2006) Berman (1999) Subtotal (I-squared = 61.6%.03 (0. 1.02.94) -0. 0.Function Study Verified Blinding Witt (2005) Foster (2007) Scharf (2006) Subtotal (I-squared = 83.105) . 1. p = 0.44 (0.37 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function Table 7.83) 1.46) 1.58) 0.12.28.08 (0.89) 0. Non-Verified Blinding Vas (2004) Berman (2004) Takeda (1994) Sangdee (2002) Sangdee (2002) Subtotal (I-squared = 69. Results of Meta-Regression of Effect of Level of Patient Blinding on Effect Size Outcome p-value % of Between-Study Variance Accounted For Residual I2 Pain Function (WOMAC) 0.0% 74.Figure 23.36.87 (0.01 0.82.8 0 .5 .32 (0. 0.32) 0. 1.05.07.27 (-0.03.47 (0.46) 0. 0.7% 74.07) 1. p = 0.002) .65 (0.04 50.51) 0. p = 0. Acupuncture vs.18 (-0.25) 0. 0. Control .61.23. 0.68. 1. 0.

05.Figure 28 present the results of acupuncture vs.2) 20. Figure 24.86) 20. 0.22 (4.15) 163. therefore. placebo on the WOMAC Pain subscale for various durations.39) 45.06 (-0.12 (4.34 (-0.15. 4.57 (0.88 (4.92 (3. 6.WOMAC Pain (4 weeks) N.5 . Acupuncture WOMAC Pain Sangdee (2002) Berman (2004) Sangdee (2002) Takeda (1994) 4 weeks 4 weeks 4 weeks 4 weeks Not Verified Not Verified Not Verified Not Verified 0. We did not perform a meta-analysis of these data because not all of the relevant studies verified that patients were blinded.39.9) 46.97) 49.28.18) 173. The level of blinding for a given study is specific to the comparison being made for each outcome.7 (3.86) 0.4 (18.42) 46. 4. Placebo N.6 (3.PAIN .3) 0 Favors Placebo .15. 0. mean Study Duration Blinding SMD (95% CI) (SD). 0.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain 48 . 6.WOMAC Level of Evidence: Four Level I RCTs and Six Level II RCTs Figure 24 . Acupuncture vs. mean (SD).28) 0. 19. 6. Placebo . an individual study’s level of blinding may vary in each figure.46 (0. 6. 0.2 . Several studies (4 of 10) compared the acupuncture treatment group to both a placebo group and a non-sham control group.98) 0. 14 (12.

35) 161.23. 6.3) 113. Figure 25. Acupuncture vs.1) Berman (2004) 8 weeks Not Verified 0. 33.38 (4. We did not perform a meta-analysis of these data because one study did not verify that patients were blinded.5 . Placebo .16) 115.52 (0. Placebo (SD).14 (-0.08. 0.10 (-0.Data for WOMAC pain at 6-8 weeks.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain 49 . 6. Acupuncture WOMAC Pain Foster (2007) 6 weeks Verified -0. 0.77 (3.24 (3. 5.39 .2 .81) 73.9) 0 Favors Placebo .2 (17. 0.WOMAC Pain (6-8 weeks) N.35. 5. mean Study Duration Blinding SMD (95% CI) (SD).1) 145.42) Witt (2005) 8 weeks Verified 0.39) 169.98 (4. 24. mean N.4 (16.

Figure 26. mean N.62. 1.39) 158.8) 48.47) 49. 5.04 (0. 0.50) 157.22 (3. 3.2 .WOMAC Pain (12-14 weeks) N.The effects of acupuncture on pain (as measured by the WOMAC) at 12-14 weeks are shown below.34) Berman (2004) 14 weeks Not Verified 0.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain 50 . 3 (2. 6. mean Study Duration Blinding SMD (95% CI) (SD).28) 365. Placebo (SD). Placebo .39 .13 (-0.05. Acupuncture WOMAC Pain Vas (2004) 12 weeks Not Verified 1. 1.5 .7 (2.29 (3.4 (5. We did not perform a meta-analysis of these data because only one study verified that its patients were blinded.27 (0.6) Scharf (2006) 13 weeks Verified 0. 0.02.38) 326. Acupuncture vs. 6.3 (2.42) Favors Placebo 0 .

Placebo . Placebo (SD).5 .7) 0 Favors Placebo .2 (2. Acupuncture WOMAC Pain Witt (2005) 52 weeks Verified 0.22 (-0.8) 99.2 .WOMAC Pain (52 weeks) N.39.4) -. 28.The effects of acupuncture on pain (as measured by the WOMAC) at 26 weeks are shown below. 30 (23.7) 108.5) Foster (2007) 52 weeks Verified -0. 33. 0. 6.02. Acupuncture WOMAC Pain Berman (2004) Scharf (2006) Witt (2005) Foster (2007) 26 weeks 26 weeks 26 weeks 26 weeks Not Verified Verified Verified Verified 0.03. 33. 6.25 (0. 0.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain Figure 28.15 (-0. mean Study Duration Blinding SMD (95% CI) (SD).3) 145.14) 141.16 (4. 6. 3.42) 326.9 (22.48) 0.13) 105.9 (2. Placebo N.39) 145. mean Study Duration Blinding SMD (95% CI) (SD).5 .WOMAC Pain (26 weeks) N. mean N.12 (-0. 0.27) 0. 7.42.12 (-0.14 (-0.39) 365. 5.5 -.8 (22.5 (21.50) -0.2 Favors Placebo 0 .13 (3.2 . We did not perform a meta-analysis of these data because one study did not verify that its patients were blinded Figure 27. 2.84 (4.8 -.39 .39 . 0.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain 51 .5 (4.3) 112.8) 142.06. 5. Acupuncture vs. 0.44) 73. 0. mean (SD). Acupuncture vs. Placebo .98 (3.43) 73.13.07 (4.

25 (3.9) 0 Favors Control .2) 113. 1.42) Berman (1999) 8 weeks None 1.39 .96.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain 52 .86 (4.46 (3. 44. 0.42 (0. Acupuncture vs.4 (4. 0.WOMAC Pain (4-5 weeks) N. Control . non-sham control (wait list or usual care) on the WOMAC Pain Subscale. 5.4 (16.15 (0.5 . 4.33.3) 0 .07 (0.5) 36.38) 105.17 (3. 7. 6. Acupuncture vs. Control .7) 169.42) Berman (1999) 4 weeks None 0. mean N. 8. 24. 9. Acupuncture WOMAC Pain Foster (2007) 6 weeks None 0.Figure 29 . 0.2 .41) 37.65.44.39.56 (0.Figure 33 present the results of acupuncture vs.46 (3. We did not perform meta-analyses of these data because the relevant studies did not blind their non-sham control group patients.7 (3.5 . mean Study Duration Blinding SMD (95% CI) (SD). Control (SD). Figure 29.76 (3.46) Tukmachi (2004) 5 weeks None 2. 6.65) 124.7) 173.7 (3. 12.21 (0. mean N. Control (SD).1) Berman (2004) 8 weeks None 0. 5.9 (17.WOMAC Pain (6-8 weeks) N.2) 145.62) Witt (2005) 8 weeks None 1. 6.18.38 (4. 6. mean Study Duration Blinding SMD (95% CI) (SD).90. 1. Acupuncture WOMAC Pain Berman (2004) 4 weeks None 0.7) 10.64) 37.80) 125.92 (0.52) 67.2 . 3. 9.15.77 (3.8 Favors Control Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain Figure 30. 1.56) 36.34 (3.12 (-0.18) 10.

2 .39) 108. 5.62) 316.72.WOMAC Pain (12-14 weeks) N.3 (2. 27.07 (4. 9.11) 228.30. Acupuncture vs.5) Favors Control .44) Scharf (2006) 13 weeks None 0.29 (3.42) 0 Favors Control .36. 5.4) -0.9 (2.72) 37.33. 2.87) 108. 7.07 (-0. 4 (2.01) 36.55 (0.71) 316.39 .22 (0. Acupuncture vs.34) Witt (2006) 13 weeks None 0. 7.20) 105.72.2 .WOMAC Pain (26 weeks) N.7) 158.8 0 .37. 3 (2.7) 142. 6.35) 326. 1.13 (3. 0.40. mean SMD (95% CI) (SD).62 (0. 1. 0.39.32 (3.78 (4. 0.51 (3. Control (SD). 7. mean (SD). 44.56 (3.4) Berman (2004) 14 weeks None 0.42) Scharf (2006) Foster (2007) 26 weeks None 26 weeks None 0. 0.39) 326.7 (18.5 .1) 235.62 (0.Figure 31.4 (18. 0.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain Figure 32. mean Study Duration Blinding SMD (95% CI) (SD). 4. Control N. Acupuncture Study Duration Blinding WOMAC Pain Berman (2004) 26 weeks None 0.86) 113.5 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain 53 . 5.91 (0. Control . mean N.46 (0. Control .47 (3. Acupuncture WOMAC Pain Berman (1999) 12 weeks None 1.

mean N. 6. mean Study Duration Blinding SMD (95% CI) (SD).WOMAC Pain (52 weeks) N. Acupuncture WOMAC Pain Foster (2007) 52 weeks None -0. Control (SD).40. Acupuncture vs.12 (-0. 6. Control .84 (4.2 . 0.5 .8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Pain 54 .29 (4.7) 99.Figure 33.16) 98.7) 0 Favors Control .39 .

mean Study Duration Blinding SMD (95% CI) (SD).52 (1. 0. 31.55 (0.01) 26. Figure 34.91) 71. non-sham control. 1. Acupuncture VAS Pain Sangdee (2002) 4 weeks Not Verified 0.8 (23.5 .98 (0.84) 49. 18.4) 46. Placebo . None of the relevant studies verified that their patients were blinded.3) Molsberger (1994) 5 weeks Not Verified 0.VAS Level of Evidence: One Level I RCT and Three Level II RCTs Figure 34 .44 (0. Placebo (SD).10. Acupuncture vs. 22 (21.6 (22. 3.2) Sangdee (2002) 4 weeks Not Verified 0. 2.6 (22. 1. placebo on pain measured by VAS. 40.55.PAIN .23 Favors Acupuncture *Dashed line indicates MCII for VAS Pain 55 .42) 45.Figure 35 depict the results of acupuncture vs.03.4) 46.46 (1.91) Favors Placebo 0 . mean N.VAS Pain (4-5 weeks) N.2 . while Figure 36 depicts the results of acupuncture vs.8 1.

16 (1. Acupuncture VAS Pain Tukmachi (2004) 5 weeks None 2.29) 10.23 Favors Placebo Favors Acupuncture *Dashed line indicates MCII for VAS Pain Figure 36.VAS Pain N. mean N.32 (0.5 . Acupuncture vs. 6.5) Favors Control 0. 3. 37. Control . mean N.Figure 35.23 Favors Acupuncture *Dashed line indicates MCII for VAS Pain 56 .88.3) 10.8) 0 . Control (SD). Placebo . Acupuncture vs.VAS Pain (12 weeks) N.2 .76) 49.2 (26.2 .5 .9 (2.6 (10. mean Study Duration Blinding SMD (95% CI) (SD). Acupuncture VAS Pain Vas (2004) 12 weeks Not Verified 1. 1.7 (2.04. 1. mean Study Duration Blinding SMD (95% CI) (SD). 10.3) 48. Placebo (SD).8 1.81.

1.54. Acupuncture Numerical Rating Scale (NRS) 2 weeks None 0.46 (-0. mean N. 4.44) 4 weeks None 0. 2003) N.45) 8.8 Favors Acupuncture 57 . mean Duration Blinding SMD (95% CI) (SD).31 (1. Control (SD). 3.5 . 1. Acupuncture vs.NRS Level of Evidence: One Level II RCT Figure 37.84) Favors Control 0 .15) 8. Control – NRS Pain (Ng et al. 3. 4.31 (.31 (1.21.95) 8.01 (1.PAIN .85) 8.2 .82 (-0.

mean (SD). an individual study’s level of blinding may vary in each figure.05 (-0. 0. 4.2) 101.08 (2. 4. 2007) N. 4. Placebo – NRS Pain Intensity (Foster et al.55) 0.3) 0 Favors Placebo .1) 110. Acupuncture vs.29 (-0.69 (2.28 (0.PAIN INTENSITY .19 (2.3) 108. Acupuncture vs. mean Duration Blinding SMD (95% CI) (SD).02. 0.7 (2.3) 0 Favors Control .24) -0.31) -0.5 .3) 108. 4.39 (2.00 (-0. -0.02) -0. Placebo N.19 (2. 0.28.04.8 Favors Acupuncture *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.03 (-0. 0. Control N. 2.55. 4.72 (2. 4. Acupuncture Pain Intensity (NRS) 2 weeks 6 weeks 26 weeks 52 weeks None None None None 0.3) 113.2 .3) 100.88. 4.84. 4.65 (2. 4. The level of blinding for a given study is specific to the comparison being made for each outcome.60 (-0. Acupuncture Pain Intensity (NRS) 2 weeks 6 weeks 26 weeks 52 weeks Verified Verified Verified Verified -0. mean Duration Blinding SMD (95% CI) (SD). 4. 58 . mean (SD).2) 105. 4. 2007) N.09 (2. -0.2 .1) 104.2) 97.5 .49) -0.92 (2.58 (-0. 5.27) 112. 0.3) 113.4 (2.59 (2.1) 112.21) -0.3) 100.32) 115. -0.72 (2. 3.69 (2.NRS Level of Evidence: One Level I RCT Figure 38.31. 4.8 Favors Acupuncture Figure 39.33 (2.2) 112.4 (2.1) 110. 4.23 (-0. therefore.30. Control – NRS Pain Intensity (Foster et al.

3) 100. an individual study’s level of blinding may vary in each figure. 4. mean Duration Blinding SMD (95% CI) (SD). Control .8 Favors Acupuncture *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.08. 2007) N. 2007) N.5 .4) 0 Favors Control . mean N. Control (SD).18 (-0.NRS Pain Unpleasantness (Foster et al.05 (-0.97 (2.4) 26 weeks Verified 0.13 (-0. 59 .3) 113. The level of blinding for a given study is specific to the comparison being made for each outcome.66 (2.15) 104.13 (-0.09 (2. 0.05 (2. 4. Acupuncture vs. 4. 4. mean N. Acupuncture vs.34 (2.2 .3) 108.4) 26 weeks None -0.14.21) 110.52 (2. 0.78 (2.2) 108.25.08 (2. 4. 4.2 .40) 110. 4.34 (2. Acupuncture Pain Unpleasantness (NRS) 6 weeks Verified -0.4) 52 weeks None 0. 0.PAIN UNPLEASANTNESS . 4. 4.4) 0 Favors Placebo .NRS Level of Evidence: One Level I RCT Figure 40.78 (2. Placebo (SD). 0.22) 101. 4.45) 105.32.05 (-0.4) 52 weeks Verified -0.2) 100.4 (2.09 (2.40.8 Favors Acupuncture Figure 41. 0. Placebo – NRS Pain Unpleasantness (Foster et al. 5. mean Duration Blinding SMD (95% CI) (SD).31.03 (-0. 0. 3.30) 97. Acupuncture Pain Unpleasantness (NRS) 6 weeks None 0.5 .2) 113. therefore.

5 (10. Acupuncture Pain affective (SES) 8 weeks None 0. mean N. 60 . 0. 0. 0.3 (9.SES Affective Pain (Witt et al. Control .4) 145.11) 145. Acupuncture vs. an individual study’s level of blinding may vary in each figure.16 (-0.4 (10.2) 0 Favors Placebo . 42. 44.37 (0.8 *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.18 (-0. 42.5 . 43.5 Favors Acupuncture . Placebo – SES (Schmerzempfindungs-Skala) Affective Pain (Witt et al. The level of blinding for a given study is specific to the comparison being made for each outcome. therefore.51) 73.08. mean Duration Blinding SMD (95% CI) (SD).1) 0 Favors Control . 42.4) 145.22 (-0.9 (8. Placebo (SD). 0.19) 145.2 .13.06.3) 52 weeks Verified 0.1 (8. 2005) N. 45.4 (9.2 . Acupuncture vs. 44.46) 73.1) 26 weeks Verified 0. 41. mean N.1 (10.AFFECTIVE PAIN – SES Level of Evidence: One Level I RCT Figure 42. Control (SD).4 (10. mean Duration Blinding SMD (95% CI) (SD).8 Favors Acupuncture Figure 43. Acupuncture Pain affective (SES) 8 weeks Verified 0.44) 73.66) 67. 2005) N.10.

0.8 Favors Acupuncture Figure 45.1 (8.26 (-0.06 (-0.36) 73.5) 145.3 (10.3) 0 Favors Placebo .2) 52 weeks Verified 0. mean Duration Blinding SMD (95% CI) (SD).50) 73. 46 (9. 47. 0. 47.SES Level of Evidence: One Level I RCT Figure 44. 0. an individual study’s level of blinding may vary in each figure. Control – SES Sensoric Pain (Witt et al.SENSORIC PAIN . 48.8 *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.55) 67. Acupuncture vs.20.03.7 (11.54) 145.07.3) 145. 2005) N.1) 0 Favors Control .3 (10.8 (8.4 (10. Placebo (SD). Control (SD). Acupuncture Pain sensoric (SES) 8 weeks None 0.19) 145. mean Duration Blinding SMD (95% CI) (SD). mean N. 0. 49. 48 (9.34) 73.22.2 .22 (-0. therefore.1) 26 weeks Verified 0. Placebo – SES Sensoric Pain (Witt et al. 61 .2 . 2005) N. Acupuncture Pain sensoric (SES) 8 weeks Verified 0. The level of blinding for a given study is specific to the comparison being made for each outcome. 48.08 (-0. Acupuncture vs.5 .5 Favors Acupuncture . mean N. 47.

48) 20.Pain Rating Index (Takeda et al.5 . 1.36 (-0. Placebo . 10.98) 20.8 Favors Acupuncture 62 . 15 (17.PAIN RATING INDEX Level of Evidence: One Level II RCT Figure 46.1) 20.5) 20. Acupuncture vs. mean N.2 (7. Placebo (SD). mean Duration Blinding SMD (95% CI) (SD).2 .5 (5.27.43) 0 Favors Placebo .39) 4 weeks Not Verified 0. Acupuncture Pain Rating Index 3 weeks Not Verified 0. 6. 0. 14.18.3 (12. 1994) N.83 (0.

11. N. 2. 1999) N. Placebo -Present Pain Intensity (Yurtkuran et al. mean mean (SD).42) 25.4) 25.2 . Placebo Acupuncture Present Pain Intensity (PPI) 2 weeks Not Verified 1. .5 (. Acupuncture vs. Duration Blinding SMD (95% CI) (SD).PRESENT PAIN INTENSITY Level of Evidence: One Level II RCT Figure 47.8 Favors Acupuncture 63 .5 .01) Favors Placebo 0 . 0 (.77 (1.

02. 22. 16.59) 73.2 . 2005) N.4) 26 weeks Verified 0.2 (9.5 .54 (0.8 Favors Acupuncture Figure 49.PAIN DISABILITY INDEX Level of Evidence: One Level I RCT Figure 48. an individual study’s level of blinding may vary in each figure. mean N. Acupuncture vs. Acupuncture Pain Disability Index 8 weeks None 1.03.5 . 0. 27. Placebo .36) 145.2 .Pain Disability Index (Witt et al. therefore. 23. 1. Placebo (SD).4 (9.30 (0. The level of blinding for a given study is specific to the comparison being made for each outcome. Acupuncture Pain Disability Index 8 weeks Verified 0. mean N.71.02 (0.53) 73. Control . 18. 64 . 22.6 (15) 145. 16. mean Duration Blinding SMD (95% CI) (SD).25. Control (SD).Pain Disability Index (Witt et al.33) 145. 0.4 (11.4) 0 Favors Control .25 (-0.82) 73.8 Favors Acupuncture *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.8 (15. mean Duration Blinding SMD (95% CI) (SD).32) 67. 2005) N.4 (11. Acupuncture vs.3) 145. 20 (14) 0 Favors Placebo .6 (13) 52 weeks Verified 0. 0.

32) 36.2 .33. 7. 9. 12. Placebo .48) 0.85) 36.98) Favors Placebo 0 .23 (-0. 8. 1. Control .Lequesne Index N. mean N.99 (0.78) 46.22.69 (0.34 (4.Lequesne Index N. 8. 10.6 (3. 9.66 (0. mean Study Duration Blinding SMD (95% CI) (SD).5 .5 .98) Sangdee (2002) 4 weeks Not Verified 0. 12. Acupuncture vs.89 (4.18. 1. Placebo (SD). 1.22) 46.29) 37. Acupuncture vs.7 (2.16) 0.8 Favors ControlFavors Acupuncture 65 .24.96 (3.63) 49. Control N.81 (0.47) 36. 12.4 (3.32) 37. 9.12) 37.2 (3.LEQUESNE INDEX Level of Evidence: Two Level II RCTs Figure 50.51.8 Favors Acupuncture Figure 51. mean Study Duration Blinding SMD (95% CI) (SD).09) 0 . Acupuncture Lequesne Index Berman (1999) Berman (1999) Berman (1999) 4 weeks 8 weeks 12 weeks None None None 0.09) 45.7 (3. 1.34 (2. mean (SD).05 (3. Acupuncture Lequesne Index Sangdee (2002) 4 weeks Not Verified 0.2 . 0.

41 (-0.1) Takeda (1994) 4 weeks Not Verified 0.71) 46.58.57) Sangdee (2002) 4 weeks Not Verified 0.2 Favors Placebo 0 . Placebo .5 .25 (1.68) -. Acupuncture vs. 69 Figure 53 presents the results of three RCTs investigating acupuncture vs. placebo using the WOMAC Stiffness subscale at 4 weeks. 68. 8.22) 20. 1.16 (-0.90) 45. Figure 52. 67.32. non-sham control using the WOMAC Stiffness subscale at all durations. The level of blinding for a given study is specific to the comparison being made for each outcome.2 .5 -. 0. mean Study Duration Blinding SMD (95% CI) (SD). mean N.95) 46.21. 2.04 (1.03 (6. 70 while Figure 54 presents the results of four RCTs investigating acupuncture vs.8 -.56) 49. 68.11 (2. 2.57 (5.WOMAC Stiffness (4 weeks) N.07.39. 2.STIFFNESS . an individual study’s level of blinding may vary in each figure.58. 3.25.53 (1. 72 Several studies (2 of 7) compared the acupuncture treatment group to both a placebo group and a non-sham control group.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Stiffness 66 . Acupuncture WOMAC Stiffness Sangdee (2002) 4 weeks Not Verified 0. therefore.49 (0.WOMAC Level of Evidence: Three Level I RCTs and Four Level II RCTs Figure 52 presents the results of two RCTs investigating acupuncture vs. 0.04) 20. placebo using the WOMAC Stiffness subscale at all durations greater than 4 weeks. Placebo (SD). 5.

1) 0.37 (0.5 (2. 37. 4.WOMAC Stiffness (all durations) N.5 .3) 1.40 (1.6) 145. Acupuncture vs.6) Scharf (2006) Witt (2006) 13 weeks None 13 weeks None 0. Control .9 (21.04.63) 326.65) 73. 3. 42. 55 (13.6) 48.63) Favors Control 0 . Acupuncture vs.82 (0.1) 326.58) 316.08 (-0.63) 145.6) 145.07.7) 10.58) 10. 4.63) 0.1 (28) Favors Placebo .2) 12 weeks Not Verified Scharf (2006) 13 weeks Verified Scharf (2006) 26 weeks Verified Witt (2005) Witt (2005) 26 weeks Verified 52 weeks Verified 0.61) 316. 1. 50.7 (16.10.2 . Acupuncture WOMAC Stiffness Witt (2005) Vas (2004) 8 weeks Verified 0. 3. 0.78 (0.3 (2.Figure 53.5 (2. 0.3) 145.3 (2.4 (25. 40. Placebo N. 3.1 (2.6 (2. Control N. 0.WOMAC Stiffness (8-52 weeks) N. 3.39 .11 (-0.46 (0.8 0 . 0.42 (0.63) 0. 0. 33.32. 0. 5. mean (SD).41. 47. 3. mean Study Duration Blinding SMD (95% CI) (SD).89) 0.59. 3.30. 0.5) Scharf (2006) 26 weeks None 0.5 (2.23) 365. 2. mean (SD). 34.4 (1. 32.22.3) 326.63) 326.63) 235.26.74) 67. 2.8 (1.63) 0.2 .7 (16.7 (25. 3.22 (-0. 32. Acupuncture WOMAC Stiffness Tukmachi (2004) 5 weeks Witt (2005) 8 weeks None None 2.8 .42 (1.24) 73. mean Study Duration Blinding SMD (95% CI) (SD).5 Favors Acupuncture *Dashed line indicates MCII for WOMAC Stiffness 67 . 0.7 (2.6 (2.61 (0.97) 228.39 Favors Acupuncture *Dashed line indicates MCII for WOMAC Stiffness Figure 54.26) 365. .3 (14) 49. Placebo .50) 73.3 (26.09.06.5 (21. 1.3 (1.

47 (0.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function 68 . mean Study Duration Blinding SMD (95% CI) (SD). 21.31.WOMAC Function (4 weeks) N.5 .58) 49.WOMAC Level of Evidence: Four Level I RCTs and Five Level II RCTs Figure 55 . 0. 48 (43. Placebo . 19 (13) Berman (2004) 4 weeks Not Verified 0. 32. 60 (45.27 (-0.37 . 58. non-sham control at various durations on the WOMAC Function subscale.9) 46. 60. 68.89) 20. The level of blinding for a given study is specific to the comparison being made for each outcome.3 (12.2) Takeda (1994) 4 weeks Not Verified 0.23.35.08. Several studies (4 of 9) compared the acupuncture treatment group to both a placebo group and a non-sham control group.2 . therefore.14 (-0. 24.18 (-0. 0.FUNCTION .35) 163.8) 20.8 -. 18.6) -.Figure 59 present the results of trials comparing acupuncture to placebo at various durations on the WOMAC Function subscale. Figure 55. an individual study’s level of blinding may vary in each figure. Acupuncture WOMAC Function Sangdee (2002) 4 weeks Not Verified 0.7 (12) 46.31. 68-70 Figure 60 .2 Favors Placebo 0 . 71 We did not perform a metaanalysis of these data because not all of the studies verified that their patients were blinded.88) 45.Figure 64 present the result of trials investigating acupuncture vs.8 (13. mean N. 58.05. 25. Placebo (SD). 23. 67. 0.5 -.8 (12. 60. Acupuncture vs. 0.4 (12) 173.1) Sangdee (2002) 4 weeks Not Verified 0.

28. 0.65 (0.WOMAC Function (12-14 weeks) N.4 (10.4 (14.5 (12. 7.5 (12) 169. 1.1) Witt (2005) 8 weeks Verified 0.24 (0.3 (2.5 .2 .9 (12) 158. Placebo .94) 73.5 . 24. Placebo .Figure 56.7 (2.1) 145.9 (20.45) 157.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function Figure 57. 22. Acupuncture WOMAC Function Vas (2004) 12 weeks Not Verified 1.2) 0 Favors Placebo . Acupuncture vs.65. mean N.37.WOMAC Function (6-8 weeks) N.1 (15.32) 365. 27 (14. 22.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function 69 . 0.08 (0.01.4) Berman (2004) 14 weeks Not Verified 0.4) 48.51) 49.37 . 0.5) Berman (2004) 8 weeks Not Verified 0. 3. 0. 3.3) Scharf (2006) 13 weeks Verified 0. 23. 20. 19.03. mean N.46) 161.7) 113. Acupuncture vs. 21. 35.23 (0.8 (12.1 (12. 0.17 (0.36. Acupuncture WOMAC Function Foster (2007) 6 weeks Verified -0. Placebo (SD). Placebo (SD).02. mean Study Duration Blinding SMD (95% CI) (SD).02 (-0.2 . mean Study Duration Blinding SMD (95% CI) (SD).39) 326.25) 110.1) Favors Placebo 0 .

WOMAC Function (52 weeks) N.28 (-0.33.01.07 (-0.6 (2.19) 104. 0. 0.5 (23. mean Study Duration Blinding SMD (95% CI) (SD). 23.17 (0.9) 142.5 .4) 145.5) 0 Favors Placebo . 24.02.2) 110. 30.08 (-0.WOMAC Function (26 weeks) N.8 (16.44) 73. 0.32) 0.8) 145.2 (2.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function 70 . 0.2 .44) 0. 36. Placebo N. Acupuncture vs.37 . Acupuncture WOMAC Function Berman (2004) Scharf (2006) Witt (2005) Foster (2007) 26 weeks 26 weeks 26 weeks 26 weeks Not Verified Verified Verified Verified 0. Placebo . mean N.20) 141.03.9 (16) -. Placebo .5 (16. 0.2 Favors Placebo 0 . Placebo (SD). 22.8 (16.Figure 58. Acupuncture vs.02.4 (12) 365. 3.9 (12.9 (23. 0. mean (SD).8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function Figure 59.5 -. 21.4 (21.36.25 (-0.7) 100. 3. 18.5 . mean Study Duration Blinding SMD (95% CI) (SD).1) 326.37 . 23.4) 108. 33 (23) Foster (2007) 52 weeks Verified -0. Acupuncture WOMAC Function Witt (2005) 52 weeks Verified 0.54) 73.2 .21 (-0. 38.56) -0.8 -.

Figure 60.1) 36.4 (14.83) 1.5) 169.1 (10) 36.5 (12.56 (0.1 (13. 27.32. 24.9) 0.37 . 23.39.5 . Acupuncture vs. 27 (14. 22.11.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function Figure 61.34 (0. Control . Acupuncture WOMAC Function Foster (2007) 6 weeks None None None None -0.3 (13.5 Favors Control Favors Acupuncture *Dashed line indicates MCII for WOMAC Function 71 . 22. 36.27. 36.79) 1.00 (-0.2) Favors Control 0 . Control (SD). Control N.2. mean (SD).06) 125. 27.82.1 (10.26) 105. Acupuncture vs.37 .2) Berman (2004) 8 weeks Berman (1999) 8 weeks Witt (2005) 8 weeks 0 .1) Berman (1999) 4 weeks None 1.3 (14.73 (1. mean Study Duration Blinding SMD (95% CI) (SD).8 .8 (12.6) 67.32 (0. 1. Control .WOMAC Function (4 weeks) N.8 (11. 0.2 (11. 1.3) 145. mean Study Duration Blinding SMD (95% CI) (SD). 0.2. 20.57) 124.9) 113. Acupuncture WOMAC Function Berman (2004) 4 weeks None 0. 20. mean N.52) 37.8) 173. 0.54.03 (0. 50.8) 37.WOMAC Function (6-8 weeks) N.4 (11. 2.

2 (2. Acupuncture WOMAC Function Berman (1999) 12 weeks None Scharf (2006) Witt (2006) 13 weeks None 13 weeks None 1.9 (16) -0.66) 108.31.28.4) 108.4) 142.3 (2. 31 (16.WOMAC Function (26 weeks) N. Control .8) 36.10 (0. 24. mean Study Duration Blinding SMD (95% CI) (SD). mean (SD).43. 24. 0. Acupuncture vs. 0.1) 326. 4.1 (12.79) 0. 0.34. 25. 36. 3.3 (11. 0.4) 0.9) 158.07) 228.4 (15. 4. 19.60.59) 37.4) 235. Control N.WOMAC Function (12-14 weeks) N. Acupuncture WOMAC Function Berman (2004) 26 weeks None Scharf (2006) Foster (2007) 26 weeks None 26 weeks None 0.37 .9 (11.2 (13.Figure 62.8 (10.2 . Control N.4 (2.9 (12.8 0 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function 72 .65 (0.5 0 .1) Berman (2004) 14 weeks None Favors Control .9) 326.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function Figure 63. 46. Acupuncture vs. 3.7) 0.5 .04 (-0.37 .6) Favors Control .8) 316.50 (0.24) 101.40. 23.7 (2. 0.54 (0.89) 113. 18.74) 316. 1.3 (18.87 (0. mean Study Duration Blinding SMD (95% CI) (SD).1) 0.58 (0.68. 1.2. mean (SD). Control . 26.

Acupuncture vs.32.24) 97. Control (SD).5) 0 Favors Control . 0.WOMAC Function (52 weeks) N.2 (15. mean Study Duration Blinding SMD (95% CI) (SD).8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Function 73 . mean N. Acupuncture WOMAC Function Foster (2007) 52 weeks None -0.8) 100.37 .2 . 23. Control . 23.5 .04 (-0.8 (16.Figure 64.

29) 45.97 (3. mean Study Duration Blinding SMD (95% CI) (SD).8 .5. mean N. Placebo (SD).3 (4.50-FT WALK TIME Level of Evidence: Two Level II RCTs Figure 65. 0.44) 49.00.8 (6) 46.53.12 (-0. 19. Placebo .04 (-0.7) 25.1 (8.81) 46. 0. Acupuncture vs.1 (3. 4. 29. 18.37. 13.4 (4.6 (5.50-ft Walk Time N.2 Favors Acupuncture 74 .14) Favors Placebo 0 .93) 25. Acupuncture 50-ft Walk Time Yurtkuran (1999) 2 weeks Not Verified 3. 18.13) Sangdee (2002) 4 weeks Not Verified -0. 20.2) Sangdee (2002) 4 weeks Not Verified 0.

8 Favors Acupuncture 75 .19.2 .2 (14.8 (22. mean N.5) 14. 73. Control (SD).50-m Walk Time (Christensen et al.73) 15. 1. 72.8) 14.03 (0.50 METER WALK TIME Level of Evidence: One Level II RCT 75 Figure 66. Acupuncture vs. 1. 53. 53 (11) 6 weeks None 1.4) Favors Control 0 .96 (0.81) 15.25. 1992) N.5 (27. Acupuncture 50-m Walk Time 2 weeks None 0. mean Duration Blinding SMD (95% CI) (SD).5 . Control .

Control . therefore. mean Duration Blinding SMD (95% CI) (SD). 1198 (333) 26 weeks Not Verified -0. 1114 (317) 0 Favors Control . Placebo 6-min Walk Distance 8 weeks Not Verified 0. 1235 (333) 0 Favors Placebo . Acupuncture vs. 1214 (327) 161.09. 0. 0.2 .20) 142. mean N.05 (-0. 1224 (327) 141. mean N.6-Minute Walk Distance (Berman et al.59) 142. Acupuncture (SD). Placebo . Acupuncture vs.03 (-0. 0.8 Figure 68.8 *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.6-Minute Walk Distance (Berman et al. 76 . The level of blinding for a given study is specific to the comparison being made for each outcome. Acupuncture (SD).2 . 1214 (327) 125. Control 6-min Walk Distance 8 weeks None 0.07. 0.30 (0.5 Favors Acupuncture .5 Favors Acupuncture . an individual study’s level of blinding may vary in each figure. 1224 (327) 108. 1117 (317) 26 weeks None 0. 2004) N. 2004) N.53) 169.SIX MINUTE WALK DISTANCE Level of Evidence: One Level II RCT Figure 67. mean Duration Blinding SMD (95% CI) (SD).27) 169.34 (0.27.17.

5 . Acupuncture vs. 1. 1. Control (SD).2) 14.6) 6 weeks None 0.TIME TO CLIMB 20 STAIRS Level of Evidence: One Level II RCT Figure 69.69) 15.8 Favors Acupuncture 77 .93 (0.88) 15.7) Favors Control 0 .Climb 20 Stairs Time (Christensen et al.3 (11.09 (0. mean N. 35. 24.16. 21 (10. 36. Control .4 (15.31. mean Duration Blinding SMD (95% CI) (SD). Acupuncture Climb 20 Stairs Time 2 weeks None 1. 1992) N.2 .8 (15) 14.

mean N.06 (. Control . Acupuncture vs.47.38 (.Timed Up and Go (Ng et al. 2. 2.78) 8. Acupuncture Timed Up and Go 2 weeks None 1. 2.28.76) 8. 3. 2.8 Favors Acupuncture 78 .2 .86) Favors Control 0 .49) 8.01 (.5 .38 (0.62 (0. Control (SD).TIMED UP AND GO Level of Evidence: One Level II RCT Figure 70.91) 4 weeks None 1. 3. 2003) N.21 (.8) 8. mean Duration Blinding SMD (95% CI) (SD).

64) 110.94 (2.7 (2. 4.22. 5. 2007) N.05 (-0. therefore. Acupuncture Main Functional Problem Severity (NRS) 6 weeks Verified -0. 5. The level of blinding for a given study is specific to the comparison being made for each outcome. Acupuncture Main Functional Problem Severity (NRS) 6 weeks 26 weeks 52 weeks None None None 0.17.42 (2.8 Favors Acupuncture *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.NRS Severity of Main Functional Problem (Foster et al. 5.39) 105.37 (2) 113.NRS Level of Evidence: One Level I RCT Figure 71. mean (SD). Control . 0.11.07 (2.23) 104.5 .SEVERITY OF MAIN FUNCTIONAL PROBLEM .38 (0.91 (2. 4.29.42 (2. mean N. Control N. mean Duration Blinding SMD (95% CI) (SD).23 (-0. Placebo – NRS Severity of Main Functional Problem (Foster et al. 0.8 Favors Acupuncture Figure 72.1) 108.61 (2) 100.1) 100. an individual study’s level of blinding may vary in each figure. 0. 0.1) 113.84 (2) 108.03.02 (-0. 4. 4. 4. mean Duration Blinding SMD (95% CI) (SD).1) 0 Favors Control .1) 52 weeks Verified -0.32) 0. 2007) N. Placebo (SD). Acupuncture vs.04 (-0.07 (2. 0. 4.2 .50) 0. 79 . Acupuncture vs.1) 101.1) 26 weeks Verified 0.11 (-0.32.7 (2. 0. 4.24) 110.1) 97. 4.1) 0 Favors Placebo . 5.17 (2.2 .5 .

5 (15. 0.21) 326. Placebo .8 80 . 2006) N.6 (15. 35.2 . Acupuncture (SD).21) 326. 36.9 (15.7) 26 weeks Verified 0. 37.7) 0 Favors Placebo .SF-12 PHYSICAL SCALE Level of Evidence: One Level I RCT Figure 73.7) 365.09. 36.09.7) 365. mean Duration Blinding SMD (95% CI) (SD).SF-12 Physical Scale (Scharf et al. Placebo SF-12 Physical Scale 13 weeks Verified 0. Acupuncture vs. mean N.5 Favors Acupuncture .06 (-0.06 (-0.9 (15. 0.

36.40) 326. mean Duration Blinding SMD (95% CI) (SD).5 Favors Acupuncture . The level of blinding for a given study is specific to the comparison being made for each outcome. 0.SF-12 Physical Scale (Scharf et al. 33.39) 326.7) 316.2 (15. therefore. Control SF-12 Physical Scale 13 weeks None 0. 2006) N. mean N.7 (15.8) 0 Favors Control . 81 . Acupuncture vs.Figure 74.23 (0.24 (0. 33.8 *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.8) 26 weeks None 0. 0.09. Control . an individual study’s level of blinding may vary in each figure.2 . Acupuncture (SD).08.5 (15.7) 316.9 (15. 37.

mean (SD).8 (9.06.SF-36 Physical Health Score N.1 (7.9) 73.23 (-0.8) 145. 33 (10) 73.03 (-0.8 Favors Placebo Favors Acupuncture *Dashed line indicates MCII for SF-36 Physical Health 82 . 0. mean Study Duration Blinding SMD (95% CI) (SD). 0.4 (20.5 . 57. 0. 35 (10) 161.08 (-0.64) 141.51) 169. 32.4) 145. Acupuncture N. 59.26 .1 (8. 57.5) 0 .16.33) 142.07.64) 0.22 (-0.3 (19.25) 0.8 (19.05. 35. 36. 33.31) 0. 57. 0.2.4) 145.SF-36 PHYSICAL HEALTH SCALE Level of Evidence: One Level I RCT and One Level II RCT Figure 75.18. Placebo SF-36 Physical Health Score Berman (2004) Witt (2005) Berman (2004) Witt (2005) Witt (2005) 8 weeks 8 weeks 26 weeks 26 weeks 52 weeks Not Verified Verified Not Verified Verified Verified 0.2 (9.51) 0.9) 73. Placebo .35 (0.9 (20. Acupuncture vs. 0.

9 (20. 0.5 .20.61) 0.4 (20. 0.Figure 76.46 (0. mean Study Duration Blinding SMD (95% CI) (SD).1 (19.4 (19.21. The level of blinding for a given study is specific to the comparison being made for each outcome. therefore. Control . Acupuncture vs.8 (7.33) 235.2 (9. 0.5) 0 .4) 125. an individual study’s level of blinding may vary in each figure.71 (0. 31.66) 142.52. 57.77) 228.8 (7.14. 59.72) 169. 50.37 (0.4) 145. mean (SD). 36. Acupuncture N. Control SF-36 Physical Health Score Berman (2004) Witt (2005) Witt (2006) Berman (2004) 8 weeks 8 weeks 13 weeks 26 weeks None None None None 0.8 Favors Control Favors Acupuncture *Dashed line indicates MCII for SF-36 Physical Health **These studies compared the acupuncture treatment group to both a placebo group and a non-sham control group. 36. 31.26 .SF-36 Physical Health Score N.5) 67.4 (7. 0.55) 108.90) 0. 83 .50 (0.2. 50.79) 0.

ADS Level of Evidence: One Level I RCT Figure 77.6 (10.9) 52 weeks Verified 0. an individual study’s level of blinding may vary in each figure. The level of blinding for a given study is specific to the comparison being made for each outcome. 47. Control (SD).05 (-0.58) 145. 84 . 49.8 Favors Acupuncture Figure 78. Acupuncture Depression (ADS) 8 weeks Verified 0.96) 145.Depression -ADS (Witt et al. 0.2 .8 (10.2 (9.16. Acupuncture Depression (ADS) 8 weeks None 0. 48.23.33) 73. 48. 47. Placebo .1) 145. 0. mean N.8) 26 weeks Verified 0. 0.8) 0 Favors Control . Control . 2005) N. 49.40) 73. 0.15 (-0.4 (8.8 *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.7 (9. mean N.5 Favors Acupuncture .5 .2) 0 Favors Placebo .9 (10. mean Duration Blinding SMD (95% CI) (SD).DEPRESSION .12 (-0.2 .Depression (Allgemeine Depressionskala-ADS) (Witt et al.04 (-0. therefore. Acupuncture vs.32) 73.9 (10. mean Duration Blinding SMD (95% CI) (SD).24.44) 67.3) 145. Acupuncture vs. 48. Placebo (SD).3 (8.14. 48. 2005) N.

Control SF-12 Mental Scale 13 weeks None -0. Acupuncture vs. 51 (28. mean N.9 (29) 26 weeks Verified -0.5 (28.20.10) 326.5) 316. 2006) N.SF-12 Mental Scale (Scharf et al. Acupuncture (SD). mean N.2 . 51. 50. 0. Placebo SF-12 Mental Scale 13 weeks Verified -0.16.5 Favors Acupuncture .05 (-0.7 (29) 0 Favors Control .12) 326. Placebo .8 Figure 80. 51 (28. 0.01 (-0. mean Duration Blinding SMD (95% CI) (SD).5) 365. Acupuncture (SD).18.8 *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.04 (-0.5) 365.15) 326. 50. therefore. 0. 0. 51.SF-12 MENTAL SCALE Level of Evidence: One Level I RCT Figure 79.5 (28.03 (-0.5) 316. The level of blinding for a given study is specific to the comparison being made for each outcome. mean Duration Blinding SMD (95% CI) (SD). an individual study’s level of blinding may vary in each figure. Acupuncture vs. 85 .SF-12 Mental Scale (Scharf et al.11) 326. 51. 2006) N.2 .5 Favors Acupuncture . Control . 52 (29) 0 Favors Placebo .2 (29) 26 weeks None -0.20.

7) 0 Favors Placebo .6 (10.30 (0. 51 (9.1 (11.SF-36 MENTAL HEALTH SCALE Level of Evidence: One Level I RCT Figure 81.7 (8.00.10. mean Study Duration Blinding SMD (95% CI) (SD).01.1) 73.16 (-0.2 . 0.6 (11.8 Favors Acupuncture Figure 82. Control SF-36 Mental Health Score Witt (2005) 8 weeks None 0.5 . therefore. 52.54) Witt (2005) 26 weeks Verified 0. 0.08 (-0.19) Witt (2006) 13 weeks None 0. Acupuncture (SD).5 .9 (11) 73. 51.20.19 (0. 52.9 (8.2 .2) Witt (2005) 52 weeks Verified 0.1) 67. The level of blinding for a given study is specific to the comparison being made for each outcome. Placebo .SF-36 Mental Health Score N. 51. Acupuncture (SD). Placebo SF-36 Mental Health Score Witt (2005) 8 weeks Verified 0. 53. 86 . 51. 50. Acupuncture vs.SF-36 Mental Health Score N. 0. Acupuncture vs.7 (11.60) 145. 0. 49.6 (10. 53.3 (9.5) 73.06) 0 Favors Control .8 Favors Acupuncture *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.44) 145. an individual study’s level of blinding may vary in each figure.46) 145. mean N.36) 145.2) 228. mean Study Duration Blinding SMD (95% CI) (SD).18 (-0. 0.37) 235. Control . mean N.12.

7) PLQC Physical Capability 12 weeks Not Verified 0. 0.40) 48.5 (.7 (.5 Favors Acupuncture . Acupuncture vs.26.56) 48.4) 49.40.54) 48.8 87 .7) 49.00.01. 2. 2.80) 48.8 (. mean Outcome Duration Blinding SMD (95% CI) (SD). Placebo PLQC Negative Mood 12 weeks Not Verified 0.39 (-0. 2.40 (-0.2 (.79) 48.7) 49. Acupuncture (SD).2 (.6) PLQC Social Functioning 12 weeks Not Verified 0.14 (-0. 2.5) 49.5) 0 Favors Placebo . 2.2 .8 (.00 (-0.PROFILE OF QUALITY OF LIFE IN THE CHRONICALLY ILL (PLQC) Level of Evidence: One Level I RCT Figure 83. 0. 0.7 (. 2004) N.7) PLQC Social Wellbeing 12 weeks Not Verified 0. 0.23. mean N.5) 49.2 (. 2.1 (. 3. 3.5 (. 0. 3. 3.8) PLQC Psychological Functioning 12 weeks Not Verified 0.16 (-0. Placebo – PLQC (Vas et al.

34. 35.1 (3.53 (0.65.5 (13.5 .56) 73.4 (22. 0. therefore.54) 73.5 (18.4 (17. 0.63) 0.4) 12 weeks Not Verified 13 weeks Verified 26 weeks Verified 26 weeks Verified 52 weeks Verified 0 Favors Placebo . 3.4 .6 (3.15.3) 0.11. Acupuncture (SD).27 (-0. 1. an individual study’s level of blinding may vary in each figure.4 (28) 0.66) 49.3) 145.4 (3. 3. Placebo WOMAC Total Sangdee (2002) 4 weeks Sangdee (2002) 4 weeks Witt (2005) Vas (2004) Scharf (2006) Scharf (2006) Witt (2005) Witt (2005) 8 weeks Not Verified Not Verified Verified 0.08 (0.03. mean Study Duration Blinding SMD (95% CI) N. 0. 25.08 (-0. 36.61) 326.9 (14.63) 0.37. Acupuncture vs.08 (-0. 29.66 (0.6) 46.7 (22.9 (18) 0. mean (SD).TOTAL Level of Evidence: Three Level I RCTs and Three Level II RCTs Several studies (2 of 5) compared the acupuncture treatment group to both a placebo group and a non-sham control group.6 (16) 0. 38. 33.95) 45.07. 0.8 (11.23) 365. 3. Figure 84.2 .51) 49.WOMAC .8) 1.95) 73.23) 365.61) 145.WOMAC Total N. Placebo .1) 145.25 (-0. 0.01. 26.2) 48. 3.4 (21. 32. 9.3 (22.07.6) 46.25 (-0.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Total 88 .7) 326. 0. 0. 25. 30.3 (3. The level of blinding for a given study is specific to the comparison being made for each outcome.

6) 145.2 .13) 228. 33. mean Study Duration Blinding SMD (95% CI) (SD).9) Favors Control 0 .5) 36.69 (1. 26.54) 37. Control .4 (14. 50.1) 36. 1.1 (18) Witt (2005) 8 weeks None 1. Control (SD).52) 316.7) Berman (1999) 8 weeks None 1. 2.75. Control . Acupuncture WOMAC Total Berman (1999) 12 weeks None 1.66.86) 37.2) 0 .61) Witt (2006) 13 weeks None 0.Figure 85.21. 3.6 (11. 46. 1.6 (3.94 (0. 50 (14) 36. 4.35.2 .8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Total 89 .5 Favors Control Favors Acupuncture *Dashed line indicates MCII for WOMAC Total Figure 86.36 (0.65) 37. Control (SD). 30. Acupuncture vs.56) 326.5 .16 (0. 49. 1. mean Study Duration Blinding SMD (95% CI) (SD).02) 67. mean N.1 (14.WOMAC Total (4-8 weeks) N.9 (14.4 . Acupuncture vs.56. 0.05 (0.3) Scharf (2006) 13 weeks None 0.4 . Acupuncture WOMAC Total Berman (1999) 4 weeks None 1.WOMAC Total (12-13 weeks) N. 1. 28.6) 235.4 (16.7 (16. mean N. 31. 50.6 (18.84.3 (3.4 (17.8 .35 (0.

3 (3.49) 316. Acupuncture WOMAC Total Scharf (2006) 26 weeks None 0.1 (3. Control (SD).33 (0.4 .2 . mean N.56) 326.18. mean Study Duration Blinding SMD (95% CI) (SD).61) Favors Control 0 . 3.8 Favors Acupuncture *Dashed line indicates MCII for WOMAC Total 90 . Acupuncture vs.WOMAC Total (26 weeks) N. 4. Control .5 .Figure 87. 0.

2004) N.24 (-0.18 (.07 (-0.08 (.2 .97) 158.25. Acupuncture vs.52) 0.PATIENT GLOBAL ASSESSMENT (CONTINUOUS) Level of Evidence: One Level II RCT Figure 88.88) 108.97) 124.01 (.16.25 (. mean Duration Blinding SMD (95% CI) (SD). 91 . 2004) N. 0. mean (SD).31) 0.01. 3. 3.8 *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.19) 0.11 (-0.25 (.09 (. an individual study’s level of blinding may vary in each figure.97) 169. mean (SD). Acupuncture N. Control -Patient Global Assessment (Berman et al.29 (0.31 (.88) 0 Favors Control . 3.09.22 (. 0. 3.34 (. therefore.37) 173.5 .01. 2.03 (-0. 3.88) 157.98 (. 3.88) 125.08 (. Control Patient Global Assessment 4 weeks 8 weeks 14 weeks 26 weeks None None None None 0.26 (0.25) -0. 3.03 (-0. Placebo -Patient Global Assessment (Berman et al.27 (. 3. 3. Acupuncture vs.97) 158.32.97) 163.18.88) 0 Favors Placebo .31 (. 0. 0.97) 142. 3. mean Duration Blinding SMD (95% CI) (SD). 3.11) 0.4 (.51) 173. Acupuncture N.88) 161.48) 0.8 Favors Acupuncture Figure 89. 3.97) 142. Placebo Patient Global Assessment 4 weeks 8 weeks 14 weeks 26 weeks Not Verified Not Verified Not Verified Not Verified -0.14 (-0. 0.88) 141. 3.5 Favors Acupuncture . 0.06. 0. 3. 0.16 (. 3.2 .88) 113.4 (.97) 169. The level of blinding for a given study is specific to the comparison being made for each outcome.

Patient Global Assessment (Scharf et al. Acupuncture vs. Acupuncture vs.91.51 (1.99 (2. 2006) Events.56 (1. Control . 1.46) 2. an individual study’s level of blinding may vary in each figure. 2006) Events.Patient Global Assessment (Scharf et al. Control Patient Global Assessment (binary) 13 weeks 26 weeks . Verified Verified 1.15) 220/326 233/326 143/316 144/316 Favors Control 1 Favors Acupuncture *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.82. therefore. 4.25 (0. Placebo .16.15) 220/326 233/326 228/365 225/365 Favors Placebo 1 Favors Acupuncture Figure 91. Duration Blinding OR (95% CI) Acupuncture Events.71) 1.13. 3. None None 2. The level of blinding for a given study is specific to the comparison being made for each outcome. Duration Blinding OR (95% CI) Acupuncture Events. 2.PATIENT GLOBAL ASSESSMENT (BINARY) Level of Evidence: One Level I RCT Figure 90. 92 . Placebo Patient Global Assessment (binary) 13 weeks 26 weeks .

49) 24/46 27/46 70/113 75/145 168/326 18/49 13/45 71/115 20/73 179/365 13 weeks Verified 1 Favors Placebo Favors Acupuncture 93 . placebo at various durations. Study Duration Blinding OR (95% CI) Acupuncture Events.26) 3.01 (0. 1.RESPONDERS Level of Evidence: Three Level I RCTs and Two Level II RCTs Figure 92 .84 (1. 8.83.59. an individual study’s level of blinding may vary in each figure. Acupuncture vs. 4. 6 weeks 8 weeks Not Verified Not Verified Verified Verified 1.54.82. therefore.Figure 94 present results comparing the success rate of acupuncture vs. Several studies (4 of 5) compared the acupuncture treatment group to both a placebo group and a non-sham control group. Placebo – Responders (4-13 weeks) Events. see evidence table 17 for details. The level of blinding for a given study is specific to the comparison being made for each outcome. Figure 92.72) 2. The definition of a responder varied by study. 5.50 (1.36) 1. 1.88 (0. Placebo Responders Sangdee (2002) 4 weeks Sangdee (2002) 4 weeks Foster (2007) Witt (2005) Scharf (2006) .22) 1.10 (0.46.

Placebo .26 (0.83. Placebo . Favors Placebo 1 Favors Acupuncture Figure 94.93 (0. Acupuncture vs.81.52) 53/101 59/106 .51.Responders (26 weeks) Events.88 (0. 1.47) 173/326 186/365 Berman (2004) 26 weeks Not Verified 1. Study Duration Blinding OR (95% CI) Acupuncture Placebo Responders Scharf (2006) 26 weeks Verified 1.89) 98/186 86/183 Foster (2007) 26 weeks Verified 0.55. Favors Placebo 1 Favors Acupuncture 94 .Responders (52 weeks) Events. Events. Acupuncture vs.Figure 93.58) 55/109 59/113 . 1. 1.09 (0. Study Duration Blinding OR (95% CI) Acupuncture Placebo Responders Foster (2007) 52 weeks Verified 0. 1. Events.

02) 70/113 75/145 168/326 54/105 2/67 85/316 Favors Control 1 Favors Acupuncture Figure 96.64) 34.69. 26 weeks 26 weeks 26 weeks None None None 2.99. Acupuncture vs.21.Responders (26 weeks) Events. 3.08.79.61 (1. Control Responders Foster (2007) Witt (2005) Scharf (2006) .Figure 95. 4.82 (8. 6 weeks 8 weeks 13 weeks None None None 1. Control – Responders (6-13 weeks) Events. 147.90.60) 2.54 (0. Acupuncture vs. Control Responders Scharf (2006) Berman (2004) Foster (2007) .33) 173/326 98/186 55/109 92/316 52/174 45/105 1 Favors Control Favors Acupuncture 95 . Control .75 (1. Study Duration Blinding OR (95% CI) Acupuncture Events. 2.03) 1.81) 2.36 (0.89 (2. 2. 4. Study Duration Blinding OR (95% CI) Acupuncture Events.

2. Control . Acupuncture vs. Study Duration Blinding OR (95% CI) Acupuncture Control Responders Foster (2007) 52 weeks None 1.Figure 97. Events. Favors Control 1 Favors Acupuncture 96 .04) 53/101 48/99 .67.17 (0.Responders (52 weeks) Events.

18.5 (15) 0 Favors Placebo . mean (SD). 0.5 . 16.2 .65) 49.44) 0.5 (14.9) Paracetamol Intake Sangdee (2002) Sangdee (2002) 4 weeks 4 weeks Not Verified Not Verified 0. Placebo . mean Study Duration Blinding SMD (95% CI) (SD). 139 (89.8) 46. 13.24 (-0.7) 45.Medication Intake N. Acupuncture vs. 13. 1.6) 48. Acupuncture Diclofenac Intake Vas (2004) 12 weeks Not Verified 0. 14.36. 85.9 (13.9 (14.04 (-0.MEDICATION INTAKE Level of Evidence: One Level I RCT and One Level II RCT Figure 98.16) 49. Placebo N. 0.33.9) 46.8 Favors Acupuncture 97 .74 (0.4 (48.

1) 4 weeks None 0. Control Range of Motion 2 weeks None 0. 125 (24) 8. mean N. Acupuncture (SD). 127 (23. 104 (21. 2003) N.91 (-0.97) 8. 107 (21.93 (-0. Control .12.11.RANGE OF MOTION Level of Evidence: One Level II RCT Figure 99.1) Favors Control 0 .Range of Motion (Ng et al.8 Favors Acupuncture 98 . 1.2 .3) 8. 1. Acupuncture vs.5 .95) 8. mean Duration Blinding SMD (95% CI) (SD).

99 . an individual study’s level of blinding may vary in each figure. Study Duration Blinding OR (95% CI) Acupuncture Control Adverse Events Scharf (2006) 26 weeks None 0.58) 20/145 13/73 . Placebo . Acupuncture vs.Adverse Events Events. 1 Favors Acupuncture Favors Placebo Figure 101. 1. Study Duration Blinding OR (95% CI) Acupuncture Placebo Adverse Events Scharf (2006) 26 weeks Verified 1. Events. 1. Events.Adverse Events Events.34. therefore.62.50) 91/326 97/365 Witt (2005) 26 weeks Verified 0.77. 1.74 (0. 1 Favors Acupuncture Favors Control *This study compared the acupuncture treatment group to both a placebo group and a non-sham control group.87 (0.07 (0. Acupuncture vs. The level of blinding for a given study is specific to the comparison being made for each outcome. Control .23) 91/326 97/316 .ADVERSE EVENTS Level of Evidence: Two Level I RCTs Figure 100.

1 Favors Acupuncture Favors Placebo 100 . Acupuncture vs. Note that each study interpreted all adverse events as not related to the treatment.59) 2. Figure 102.75 (0. 4.SERIOUS ADVERSE EVENTS Level of Evidence: Two Level I RCT and One Level II RCTs Figure 102 and Figure 103 present serious adverse events of acupuncture vs.59 (1.39) 20/326 3/145 14/190 9/365 2/73 5/191 Berman (2004) 26 weeks . placebo and non-sham control.Serious Adverse Events Events. respectively.04.96 (1.16.76) 0.12. Study Duration Blinding OR (95% CI) Acupuncture Events. 5. Placebo . Placebo Serious Adverse Events Scharf (2006) Witt (2005) 26 weeks 26 weeks Verified Verified Not Verified 2. 8.

2.82. 101 . Study Duration Blinding OR (95% CI) Acupuncture Control Serious Adverse Events Scharf (2006) 26 weeks None 1.41) 20/326 16/316 Berman (2004) 26 weeks None 2.07 (0.25) 14/190 7/189 . Control . 5.Serious Adverse Events Events. 1 Favors Acupuncture Favors Control *These studies compared the acupuncture treatment group to both a placebo group and a non-sham control group. Acupuncture vs. an individual study’s level of blinding may vary in each figure. The level of blinding for a given study is specific to the comparison being made for each outcome.62. Events. therefore.23 (0.Figure 103.

chondroitin sulfate. The remaining five systematic reviews did not provide conclusions on the clinical importance. but the evidence is insufficient to draw conclusions.12 and all of the quotations in this subsection are from that report: “The best available evidence found that glucosamine hydrochloride. Five of six meta-analysis’ concluded that glucosamine or chondroitin were superior to placebo. or their combination did not have any clinical benefit in patients with primary OA of the knee. Supporting Evidence This recommendation is addressed by the AHRQ Report.” (p. the MA (meta-analyses) results do not outweigh the GAIT results due to lower quality of the primary literature and small differences reported. or their combination provide no clinical benefit in patients with primary OA of the knee. adverse events with glucosamine or chondroitin treatment were no greater than placebo.RECOMMENDATION 12 We recommend glucosamine and/or chondroitin sulfate or hydrochloride not be prescribed for patients with symptomatic OA of the knee.106) “Glucosamine sulfate has been reported to be more effective than glucosamine hydrochloride. AAOS Level of Evidence: I AAOS Grade of Recommendation: A Rationale: This recommendation is based on an Agency for Healthcare Research and Quality (AHRQ) report12 that provides evidence from one RCT and six systematic reviews (Table 8) on the use of glucosamine and/or chondroitin sulfate or hydrochloride among patients with symptomatic OA of the knee. they conclude glucosamine and/or chondroitin are superior to placebo (Table 9).” (p. chondroitin sulfate. However. however.”12 One of the six systematic reviews concluded no clinical benefit for glucosamine or chondroitin compared to placebo.107) 102 .106) “In general. We evaluated this evidence as Level I. The AHRQ report states that “the best available evidence found that glucosamine hydrochloride.” (p. The AAOS workgroup agreed that the AHRQ report presents a high quality systematic review of Level I evidence that demonstrates the best available evidence does not support prescribing glucosamine and/or chondroitin.

4% (208/318) 66.17 p = 0.6% (211/317) 70.30 p = 0.GAIT Results Outcome* 20% decrease in WOMAC pain score 20% decrease in WOMAC pain score 20% decrease in WOMAC pain score 20% decrease in WOMAC pain score Comparison Glucosamine HCl vs. Placebo Celecoxib vs.008 * 18% change in WOMAC pain is considered clinically important 19 ** p-value is from comparison to placebo Table 9.1% (223/318) p-value** p = 0. Placebo Glucosamine HCl + Chondroitin Sulfate vs.Table 8. Placebo Chondroitin Sulfate vs.Review Conclusions Systematic Review Bjordal 2006 Towheed 2006 Poolsup 2005 Richy 2003 Leeb 2000 McAlindon 2000 Treatment Evaluated Glucosamine or Chondroitin Glucosamine Glucosamine Glucosamine or Chondroitin Chondroitin Glucosamine or Chondroitin Conclusion of Systematic Review No clinical benefit Statistically significant effect in favor of glucosamine Glucosamine possesses moderate efficacy in improving symptoms Glucosamine and chondroitin are beneficial Significant efficacy of chondroitin on pain and function Glucosamine and Chondroitin may have efficacy and are safe 103 . Summary of Evidence from AHRQ Report . Placebo Result (n/N) 64% (203/317) 65. Summary of Evidence from AHRQ Report .09 p = 0.

RECOMMENDATION 13
We suggest patients with symptomatic OA of the knee receive one of the following analgesics for pain unless there are contraindications to this treatment: • Acetaminophen [not to exceed 4 grams per day] • Non-steroidal anti inflammatory drugs (NSAIDs) AAOS Level of Evidence: II AAOS Grade of Recommendation: B Rationale: The OARSI guidelines, on which this recommendation is based, provide evidence from three systematic reviews on the use of acetaminophen compared to placebo among patients with symptomatic OA of the knee.13, 14 In addition, the OARSI guidelines provide evidence from four systematic reviews that examined the use of NSAIDs compared to placebo or acetaminophen. We categorized this evidence as Level II because of the lesser quality of included trials in the systematic reviews. The evidence suggests statistically significant effects of acetaminophen on pain relief without any statistically significant risk of toxicity, when compared to placebo. The clinical importance of the effect on pain cannot be determined (Table 10). NSAIDs appear to have a statistically significant effect on pain (Table 11), the clinical importance of which cannot be determined. NSAIDs also appear to reduce pain (as measured by the WOMAC subscale) significantly more than acetaminophen, but the effect is not clinically important (Table 11). Finally, NSAIDs have statistically significant and favorable effects on clinical response and patient preference as compared to acetaminophen, but a statistically significant increased risk of gastrointestinal complications. The clinical importance of these effects cannot be determined (Table 11). Supporting Evidence Table 10 and Table 11 (see next page)

104

Table 10. Summary of Evidence from OARSI for Acetaminophen

Outcomes

Comparison

ES (95% CI)

MCII

acetaminophen Pain* d = 0.21 (0.02, 0.4) vs. placebo acetaminophen Pain* d = 0.13 (0.04, 0.22) vs. placebo acetaminophen Toxicity* RR = 1.02 (0.89, 1.87) vs. placebo d = standard mean difference ES = effect size MCII = minimal clinically important effect ? = cannot be determined/unknown
* Outcome measure is not defined by OARSI.

? ? ?

Table 11. Summary of Evidence from OARSI for NSAIDs

Outcomes

Comparison

ES (95% CI)

MCII

NSAIDs/COX-2 Pain* d = 0.32 (0.24, 0.39) vs. placebo NSAIDs/COX-2 Pain** d = 0.23 (0.15, 0.31) vs. placebo NSAIDs vs. Pain d = 0.20 (0.10, 0.30) acetaminophen NSAIDs vs. Clinical Response* RR = 1.24 (1.08, 1.41) acetaminophen NSAIDs vs. Patient preference* RR = 2.46 (1.51, 4.12) acetaminophen NSAIDs vs. GI Complications* RR = 1.47 (1.08, 2.00) acetaminophen d = standard mean difference ES = effect size MCII = minimal clinically important effect ? = cannot be determined/unknown
* Outcome is not defined by OARSI

? ?
0.39

? ? ?

** Analysis includes only trials that did not require patients to have a minimum flare of symptoms after treatment with NSAIDs was stopped before the trial

105

RECOMMENDATION 14
We suggest patients with symptomatic OA of the knee and increased GI risk (Age >= 60 years, co-morbid medical conditions, history of peptic ulcer disease, history of GI bleeding, concurrent corticosteroids and/or concomitant use of anticoagulants) receive one of the following analgesics for pain: • Acetaminophen [not to exceed 4 grams per day] • Topical NSAIDs • Nonselective oral NSAIDs plus gastro-protective agent • Cyclooxygenase-2 (COX-II) inhibitors AAOS Level of Evidence: II AAOS Grade of Recommendation: B Rationale: The OARSI guidelines, on which this recommendation is based, provide evidence from eleven systematic reviews on the use of acetaminophen, topical NSAIDs, nonselective oral NSAIDs plus a gastroprotecive agent, or COX-II inhibitors among patients with symptomatic OA of the knee that have increased risk of GI complications.13, 14 This evidence was evaluated as Level II because of the lesser quality of included trials in the systematic reviews. The effectiveness of acetaminophen is discussed in Recommendation 13. For topical NSAIDs, the evidence suggests a statistically significant effect on pain relief, stiffness, and function, but (Table 12) the clinical importance of these effects cannot be determined. The effectiveness of nonselective oral NSAIDs and COX-II inhibitors is discussed in Recommendation 13. The evidence for oral NSAIDs included trials which investigated nonselective oral NSAIDs and COX-II inhibitors (Table 11 above). Each of these regimens has a reduced relative risk for adverse GI events when compared with the isolated use of oral NSAIDs. The evidence does not demonstrate an advantage for any of these treatment regimens.13, 14 Supporting Evidence See Table 10 and Table 11 in Recommendation 13. See Table 12 next page.

106

Table 12. Summary of Evidence from OARSI for Topical NSAIDs

Outcomes
Pain* (1 week) Pain* (2 weeks) Pain* (≥ 4 weeks) Stiffness* Function*

Comparison
topical NSAIDs vs. placebo topical NSAIDs vs. placebo topical NSAIDs vs. placebo topical NSAIDs vs. placebo

ES (95% CI)
d = 0.41 (0.16, 0.66) d = 0.40 (0.15, 0.65) d = 0.28 (0.14, 0.42) d = 0.49 (0.17, 0.80)

MCII

topical NSAIDs vs. placebo d = 0.36 (0.24, 0.48) d = standard mean difference ES = effect size MCII = minimal clinically important effect ? = cannot be determined/unknown

? ? ? ? ?

* Outcome is not defined by OARSI

107

RECOMMENDATION 15
We suggest intra-articular corticosteroids for short-term pain relief for patients with symptomatic OA of the knee. AAOS Level of Evidence: II AAOS Grade of Recommendation: B Rationale: Intra-articular (IA) corticosteroid treatment in patients with symptomatic OA of the knee was examined in three Level II systematic reviews15, 66, 76 which include lesser quality RCTs. A total of twelve unique RCTs comparing corticosteroid and placebo interventions were included in these reviews.17, 77-87 All three of the systematic reviews conclude that IA corticosteroids are effective for relieving pain in the short term (one week, 16-24 weeks,76 at one week and continuing at two to three weeks,15 and within 1-2 weeks66). The only systematic review that commented on whether these effects were clinically important concluded that the effects on pain at 1-2 weeks were not.66 However, we were able to evaluate clinical importance using data from another systematic review.15 The three RCTs considered in that review suggest possibly clinically important and statistically significant effects of intra-articular corticosteroids on pain (as measured by the VAS) one week after injection (Figure 105). There is little evidence suggesting that intra-articular steroids have longer term benefits. Supporting Evidence For the raw data addressing this recommendation, please see evidence tables: 18 – 19. Figures relevant to this recommendation are Figure 104 – Figure 127. The relevant study attrition diagram is shown in Appendix III.

108

91 (13. 76 assessed pain measured by VAS. Bjordal et al.49) 5.39) 5.PAIN: VAS Level of Evidence: Three Level II Systematic Review All three previously published systematic reviews15. 79. A total of seven RCTs were examined within these systematic reviews.60 (-4. 19.96.20) 16. 29.03. 25.70. 15.92) 6.89. 66. 2007.00) 11.93) 14.20 (0.40. 10.80.70 (0.50 (9. 27. 2007) Review Duration WMD (95% CI) Bellamy (3 RCTs) 1 week Bjordal (6 RCTs) Arroll (5 RCTs) Bjordal (6 RCTs) Bellamy (1 RCT) Bjordal (2 RCTs) Bellamy (1 RCT) Bjordal (4 RCTs) Bellamy (1 RCT) Bellamy (1 RCT) 1-2 weeks 2 weeks 4 weeks 4 weeks 6 weeks 6 weeks 8-12 weeks 12 weeks 24 weeks 21. 81 Figure 104.40. 22.01. 13.44) 7.20) 14.09.47 (10.30 (-8.10 (-4.20 (-3. Bellamy et al.19.60) 7. WMD in pain measured by VAS (three systematic reviews: Arroll & Goodyear-Smith 2004.61) 0 Favors Placebo Favors Steroid 109 . three of which were included in all three systematic reviews. 18.17. 22.50 (0.

8 (26.8) 28. 53 (27.7 (20.20.16. 110 .27 (-0. 0. 0. 1. 47 (26. 0.6) 12. 33.8 1.2 (21. 61. mean (SD). 81 Figure 105.70) 0.42 (-0.PAIN: VAS Level of Evidence: One Level II Systematic Review One previously published systematic review15 assessed pain measured by VAS. 42.8 (26.9) 12. Placebo N.17.26 (-0. 2007) N. 1. 70 (30) 42. Pain measured by 100 mm VAS (systematic review Bellamy et al. Steroid VAS Pain Dieppe Gaffney Ravaud Ravaud Gaffney Ravaud Ravaud 1 week 1 week 1 week 4 weeks 6 weeks 12 weeks 24 weeks 0.2 . 1.7) 25. 79. 58.30) 1. 50.8) Favors Placebo 0 . 21.74 (0.97) 0. 42.23 Favors Steroid *Dashed line indicates MCII for VAS pain.14) 0.6) 42.58 (0.28. mean Outcome Author Duration SMD (95% CI) (SD).1 (27.06 (0.9) 28.7 (23.7) 25.5 .03.92) 0.9 (26) 28.43. 35.9 (29.8) 25.80) 28. 37 (32) 42.4) 42.19.32) 0. A total of three RCTs were examined.12. 1.7) 25.87 (0. 43. 54 (26.2 (26.

09. Pain was assessed using VAS.15 reported one RCT82 that examined the number of responders with a reduction in pain greater than fifteen percent three weeks post injection. Patients with greater than fifteen percent reduction in pain (systematic review Bellamy et al. Outcome Duration OR (95% CI) Placebo Steroid > 15% decrease in pain (VAS) 3 weeks 5.02 (2. 2007) Events. Tubach et al.PAIN: >15% REDUCTION Level of Evidence: One Level II Systematic Review One previously published systematic review. Events.21 have reported a 40% reduction is necessary to be minimally clinically important.03) 28/59 9/59 . 1 Favors Placebo Favors Steroid 111 . 12. Although a 15% reduction in pain was selected by the authors a priori. Figure 106.

71 (0. Tubach et al. Although a 30% reduction in pain was selected by the authors a priori.PAIN: >30% REDUCTION Level of Evidence: One Level II Systematic Review One RCT17 included in a previously published systematic review15 examined the number of responders with a reduction in pain greater than thirty percent. Steroid > 30% decrease in pain (VAS) 1 week 4 weeks 12 weeks 24 weeks . Patients with greater than thirty percent reduction in pain (systematic review Bellamy et al. Pain was assessed using VAS.19) 16/25 14/25 13/25 12/25 7/28 8/28 8/28 6/28 1 Favors Placebo Favors Steroid 112 .40) 3.02. 5. 11.02.33 (1.38 (1. 2007) Events. Outcome Duration OR (95% CI) Placebo Events.42) 3.63.87.18 (1. 8. 9. 17.93) 2.21 have reported a 40% reduction is necessary to be minimally clinically important. Figure 107.

6) 0 Favors Placebo .19 (-0.6) 104 weeks 0. Placebo (SD).9 (28.8 Favors Steroid *Dashed line indicates MCII for WOMAC pain. WOMAC pain assessment measured by 100 mm VAS (systematic review Bellamy et al. the patient dose regimen is defined by the author either IA steroid or IA saline injections every three months over the course of the two year study for a total of eight injections. 28. To clarify the two year duration of study. mean N. Figure 108.68) 33.PAIN: WOMAC Level of Evidence: One Level II Systematic Review One RCT17 included in a previously published systematic review15 assessed pain measured by WOMAC using a 100 mm VAS.2) 33. 22.29.7 (25. 113 . 0.7 (25.2 . mean Outcome Duration SMD (95% CI) (SD). Steroid WOMAC Pain 52 weeks 0. 33.00) 33. 2007) N.5 . 1.2) 33.51 (0. 36.02.39.5 (28.

2 (23. mean Outcome Duration SMD (95% CI) (SD). To clarify the two year duration of study.8 (23.5) 33.PAIN: AT NIGHT Level of Evidence: One Level II Systematic Review One RCT85 included in a previously published systematic review15 assessed pain at night measured by a 100 mm VAS.5 .4 (28. mean N. Figure 109.53.5 (28.10. 22. 25.05 (-0.44) 33.39 (-0. the patient dose regimen is defined by the author either IA steroid or IA saline injections every three months over the course of the two year study for a total of eight injections.8) 104 weeks -0. 2007) N. Pain at night measured by 100 mm VAS (systematic review Bellamy et al. 0. Placebo (SD).2 . Steroid Pain at night (VAS) 52 weeks 0.8) 0 Favors Placebo .8 Favors Steroid 114 . 23.5) 33.88) 33. 0. 15.

04) 15/17 12/17 8 weeks 1.13 (0.51. Patients reporting pain reduction (systematic review Bellamy et al. 1 Favors Placebo Favors Steroid 115 . 4.08) 11/17 11/17 . 2007) Events.24. Figure 110. Outcome Duration OR (95% CI) Placebo Steroid Pain Reducation 1 week 3.00 (0. Events.PAIN: REDUCTION Level of Evidence: One Level II Systematic Review One RCT80 included in a previously published systematic review15 assessed the number of patients reporting a reduction in pain. 19.

Outcome Duration OR (95% CI) Placebo Steroid Improvement: Hydrocortisone Acetate (HCA) 2 weeks 1.37 (1. Improvement: Hydrocortisone Tertiary-Butylacetate (HCHTB) 2 weeks 3. 8. Figure 111.93) 25/38 12/33 .54) 19/38 12/33 .27.75 (0. Events. Authors considered improvement as a participant rating symptoms less severe than the initial baseline assessment. 4.PAIN: IMPROVEMENT Level of Evidence: One Level II Systematic Review One RCT87 included in a previously published systematic review15 examined the number of knees with improvement in pain two weeks post injection.68. Knees with improvement after two weeks (systematic review Bellamy et al. 1 Favors Placebo Favors Steroid 116 . 2007) Events.

26. the patient dose regimen is defined by the author either IA steroid or IA saline injections every three months over the course of the two year study for a total of eight injections. mean N.8) 33. 0. 0. mean Outcome Duration SMD (95% CI) (SD). 26.2 .5 Favors Steroid .2 (26.25 (-0.8 *Dashed line indicates MCII for WOMAC function. Figure 112. Steroid WOMAC Physical Function 52 weeks 0.73) 33. Placebo (SD). 22 (21. To clarify the two year duration of study.8) 33. 20.7) 104 weeks 0.FUNCTION: WOMAC Level of Evidence: One Level II Systematic Review One RCT85 included in a previously published systematic review15 assessed function measured by WOMAC using a 100 mm VAS.31. 117 .7) 0 Favors Placebo .17 (-0.2 (26.66) 33.24.2 (21. 2007) N.37 . WOMAC physical function measured by 100 mm VAS (systematic review Bellamy et al.

pain.38. 4. Figure 113. The HAQ is a fivedimension.8 Favors Placebo Favors Steroid 118 .05 (-0.2 (2) 42.14 (-0. medication effects. 2007) N.2 .57.5 (2. costs of care and mortality. mean Outcome Duration SMD (95% CI) (SD).FUNCTION: MODIFIED HEALTH ASSESSMENT QUESTIONNAIRE (HAQ) Level of Evidence: One Level II Systematic Review One RCT81 included in a previously published systematic review15 utilized the Health Assessment Questionnaire (HAQ) modified for lower limb function. Function measured by HAQ (systematic review Bellamy et al. 0. 0. mean (SD). 4.3 (1. Placebo N. Steroid Function: Modified HAQ 1 week 6 weeks 0.9) 42. patient-oriented measure assessing disability.48) -0.2 (2. 4.3) 0 .5 . 4.29) 42.1) 42.

1 (4.2 . 9. 2007) N.5) 0 Favors Placebo . mean Outcome Duration SMD (95% CI) (SD). 0.52 (-0.1) 25. Steroid Function: Lequense 1 week 0.81) 28.07) 0. 0. 1.FUNCTION: LEQUESNE Level of Evidence: One Level II Systematic Review One RCT17 included in a previously published systematic review15 assessed function as measured by the Lequesne Index.27. 10.27 (-0. 8.31.4 (4.5 . 10. Function measured by Lequesne Index (systematic review Bellamy et al. mean (SD).03.9 (5.8 Favors Steroid 119 . Figure 114.23 (-0. 7.3) 25.5) 28. 9.1 (4. 10.77) 0.6) 4 weeks 12 weeks 24 weeks 0.6 (4. 0. 9.5) 28.3) 25. Scoring on the ten question Lequesne Index ranges from 0-24 with lower scores indicating less functional impairment.3) 25.4 (4. Placebo N.1 (4.7 (4.99) 28.10.44 (-0.

50. mean Outcome Author Duration SMD (95% CI) (SD). 38.88) 0.3 (33. 58.50) 0.97) 0.66) 0.1 (29.05.8 (27. Steroid N.5) 25. 120 .9) 25.5 . Placebo Patient Global Assessment (VAS) Ravaud Ravaud Ravaud Ravaud Raynauld Raynauld 1 week 4 weeks 12 weeks 24 weeks 52 weeks 104 weeks 0.2 (31.13.9 (29. 85 included in a previously published systematic review15 assessed patient global assessment measured by 100 mm VAS.6 (30. 37 (27.5) 0 Favors Placebo .4) 33. 41. 62 (28.5) 33. 39. 57.04) 0. 2007) N. 0.6) 28.44.1 (30) 28.2 (29.33 (-0.8) 25.47. 1.3) 33.5) 25. 60. 0.12 (-0.1 (25. Figure 115. 47. 0.2) 28.5) 33.04 (-0. mean (SD). 0.8 Favors Steroid 1 *Dashed line indicates MCII for global assessment (VAS). 38.2 .01 (-0. 0.GLOBAL ASSESSMENT Level of Evidence: One Level II Systematic Review Two RCTs17.21. 60.42. Global assessment measured by 100 mm VAS (systematic review Bellamy et al.50 (-0.52) 28.42 (-0.1 (31.

GLOBAL ASSESSMENT: IMPROVEMENT Level of Evidence: One Level II Systematic Review Four RCTs78, 81, 83, 84 included in a previously published systematic review15 examined patients with improved global assessment. All measurements utilized the 100 mm VAS. Figure 116. Patients with improved global assessment (systematic review Bellamy et al. 2007)
Events, Outcome Author Duration OR (95% CI) Placebo Events, Steroid

Patients improved (global) Cederlof 1 week Gaffney Popov 1 week 1 week 1.77 (0.56, 5.57) 18/26 14/25 20/42 8/11 20/25 23/42 28/36 19/25 32/34

4.03 (1.55, 10.47) 33/42 4.13 (0.36, 47.30) 11/12 0.68 (0.18, 2.51) 1.10 (0.47, 2.61) 1.48 (0.46, 4.78) 0.60 (0.18, 2.03) 0.47 (0.08, 2.75) 19/26 24/42 31/37 17/26 30/34

Cederlof 3 weeks Gaffney Miller 6 weeks 6 weeks

Cederlof 8 weeks Miller . 6 months

1 Favors Placebo Favors Steroid

121

STIFFNESS: WOMAC Level of Evidence: One Level II Systematic Review One RCT85 included in a previously published systematic review15 assessed stiffness measured by WOMAC using a 100 mm VAS. To clarify the two year duration of study, the patient dose regimen is defined by the author as either IA steroid or IA saline injections every three months over the course of the two year study for a total of eight injections. Figure 117. WOMAC stiffness measured by 100 mm VAS (systematic review Bellamy et al. 2007)
N, mean N, mean

Outcome

Duration

SMD (95% CI)

(SD); Placebo

(SD); Steroid

WOMAC stiffness

52 weeks

0.20 (-0.28, 0.69)

33, 38.8 (33.6)

33, 32.1 (32.7)

104 weeks

0.26 (-0.23, 0.74)

33, 41.8 (33.6)

33, 33.2 (32.7)

0 Favors Placebo

.2 .39 .5 Favors Steroid

.8

*Dashed line indicates MCII for WOMAC stiffness.

122

WOMAC TOTAL Level of Evidence: One Level II Systematic Review One RCT85 included in a previously published systematic review15 examined total WOMAC score measured by 100 mm VAS. To clarify the two year duration of study, the patient dose regimen is defined by the author as either IA steroid or IA saline injections every three months over the course of the two year study for a total of eight injections. Figure 118. Total WOMAC score measured by 100 mm VAS (systematic review Bellamy et al. 2007)
N, mean N, mean

Outcome

Duration

SMD (95% CI)

(SD); Placebo

(SD); Steroid

WOMAC Total

52 weeks

0.30 (-0.18, 0.79)

33, 29.4 (25)

33, 21.6 (26.7)

104 weeks

0.18 (-0.31, 0.66)

33, 28.8 (25)

33, 24.2 (26.7)

0 .2 .5 .8 Favors Placebo Favors Steroid

123

WALKING DISTANCE Level of Evidence: One Level II Systematic Review One RCT81 included in a previously published systematic review measured walking distance (in meters) over one minute. Figure 119. Distance walked over one minute measured in meters (systematic review Bellamy et al. 2007)
N, mean N, mean

Outcome

Duration

SMD (95% CI)

(SD); Steroid

(SD); Placebo

Walking Distance

1 week

0.15 (-0.28, 0.58)

42, 50.7 (15.3)

42, 48.3 (16.3)

6 weeks

-0.05 (-0.48, 0.37)

42, 50.8 (15.4)

42, 51.6 (14.5)

0 Favors Placebo

.2 .5 .8 Favors Steroid

124

50-FOOT WALKING TIME Level of Evidence: One Level II Systematic Review One RCT85 included in a previously published systematic review15 measured the time (in seconds) needed to walk fifty feet. To clarify the two year duration of study, the patient dose regimen is defined by the author as either IA steroid or IA saline injections every three months over the course of the two year study for a total of eight injections. Figure 120. 50-foot walk time measured in seconds (systematic review Bellamy et al. 2007)
N, mean N, mean

Outcome

Duration

SMD (95% CI)

(SD); Placebo

(SD); Steroid

50 Foot Walking Time 52 weeks 104 weeks 0.07 (-0.41, 0.55) 0.24 (-0.25, 0.72) 33, 11.6 (2.1) 33, 11.9 (2.1) 33, 11.4 (3.6) 33, 11.2 (3.6)

0 .2 .5 .8 Favors Placebo Favors Steroid

125

703.10 13.IMPROVEMENT Level of Evidence: One Level II Systematic Review Six RCTs17.40) 2. 17.00 (4.00 2 weeks 2 weeks 2 weeks 2 weeks 2 weeks 2 weeks 2. 6. Outcome Author Duration OR (95% CI) Placebo Events. Statistical significance and direction of effect are consistent with original systematic review.86 1 Favors Placebo Favors Steroid *Originally reported as risk ratios (RR) in the systematic review. odds ratios (OR) and the accompanying overall meta analysis statistic were calculated to maintain consistency through the guideline.72 (2.63.97 8. 2004) Events.1%.62 (0. Figure 121.02) 20/26 10/12 15/17 33/42 16/25 25/38 14/25 1/12 12/17 21/42 7/28 15/33 19. 86 included in a previously published systematic review76 examined the number of knees with improvement. Overall (I-squared = 16.30. 9.67 (1. 78-81.13 (0. Knees with improvement at two week duration shown as odds ratio (systematic review Arroll & Goodyear-Smith.04) 3.51) 5.310) 3.03) 119/160 70/157 100.29.19 26.41. Steroid % Weight Improvement Cederlof Dieppe Friedman Gaffney Ravaud Smith .51. 19. All six studies assessed at two weeks post injection and two of those studies also assessed sixteen to twenty-four weeks post injection. 6.79 31.31 (0.10 0.43) 3. 126 .33 (1.88. p = 0.75) 55. 8.78.

19) Ravaud 16-24 weeks 2. 127 .Figure 122. Knees with improvement at all durations shown as weighted mean difference (systematic review Arroll & Goodyear-Smith.29. 2004) Outcome Author Duration WMD (95% CI) Improvement *** 2 weeks 3.94.02.03) Smith 16-24 weeks 3.75) 0 Favors Placebo Favors Steroid ***WMD at two weeks is comprised of six RCTs shown in Figure 121.83 (1.70 (0.72 (2. 11. 6. 7.

Outcome Duration OR (95% CI) Placebo Steroid Local discomfort 1 week 2.44. 14. Figure 123. 2007) Events. Patient ratings were made using a four-point scale. Events. 1 Favors Placebo Favors Steroid 128 .LOCAL DISCOMFORT Level of Evidence: One Level II Systematic Review One RCT17 included in a previously published systematic review15 examined the number of patients reporting local discomfort one week post injection.22) 5/28 2/25 .50 (0. Patients reporting local discomfort (systematic review Bellamy et al.

1 Favors Placebo Favors Steroid 129 .29.26) 5/17 4/17 . Patients with post injection flare (systematic review Bellamy et al.POST INJECTION FLARE Level of Evidence: One Level II Systematic Review One RCT80 included in a previously published systematic review15 examined the number of patients experiencing post injection flare. Figure 124.35 (0. Events. 2007) Events. Outcome OR (95% CI) Placebo Steroid Post Injection Flare 1. 6.

Outcome Author OR (95% CI) Placebo Steroid Withdrawal:Total Ravaud 2. 1 Favors Placebo Favors Steroid 130 . 2007) Events. Events. Figure 125.74) 10/28 5/25 Raynauld 1.64. Total number of withdrawals (systematic review Bellamy et al. 85 included in a previously published systematic review15 examined the total number of withdrawals.06.22 (0.WITHDRAWALS: TOTAL Level of Evidence: One Level II Systematic Review Two RCTs17.67) 1/34 1/34 .00 (0. 16. 7.

Events.67) 1/34 1/34 . 16.WITHDRAWALS: EFFICACY Level of Evidence: One Level II Systematic Review Two RCTs17.40. Figure 126.50 (0.06. Total number of withdrawals due to lack of efficacy (systematic review Bellamy et al. Outcome Author OR (95% CI) Placebo Steroid Withdrawal:Total Ravaud 1. 85 included in a previously published systematic review15 examined the total number of withdrawals due to lack of efficacy.00 (0.65) 8/36 4/25 Raynauld 1. 2007) Events. 1 Favors Placebo Favors Steroid 131 . 5.

Number of Patients preferring treatment (systematic review Bellamy et al.31) 30/59 14/59 .51.99) 10/12 2/12 Dieppe (b) 5.58) 20/24 11/24 Jones 3.55. 1 Favors Placebo Favors Steroid 132 .PATIENTS PREFERENCE Level of Evidence: One Level II Systematic Review Two RCTs79.00 (2.92. Figure 127. 213. Outcome Author OR (95% CI) Placebo Steroid Patient Preference Dieppe (a) 25. 82 included in a previously published systematic review15 examined the number of patients preferring steroid treatment. 22. Events.33 (1. 2007) Events. 7.91 (1.

high quality RCTs. AHRQ further comments on these results. 133 . This evidence was evaluated as Level I and II because some of the trials included in the AHRQ report were not well designed. AAOS Level of Evidence: I and II AAOS Grade of Recommendation: Inconclusive Rationale: The Agency for Healthcare Research and Quality (AHRQ) report 12 upon which this recommendation is based provides evidence from 42 trials that examined the effectiveness of intra-articular hyaluronic acid (viscosupplementation) in patients with symptomatic OA. The AHRQ report states that “viscosupplementation generally shows positive effects” However.RECOMMENDATION 16 We cannot recommend for or against the use of intra-articular hyaluronic acid for patients with mild to moderate symptomatic OA of the knee. The AHRQ report explains that six meta-analyses and one additional RCT were considered in their review. and unclear clinical significance (importance).” The AAOS workgroup agreed that the AHRQ report presents a high quality systematic review of Level I and Level II evidence and graded this recommendation as inconclusive because of the conflicting evidence in pooled effects along with the unclear clinical importance of the results.” AHRQ also noted that the “pooled effects from poor-quality trials were as much as twice those obtained from higher ones (trials). potential publication bias. noting that they could have been influenced by “trial quality.

Pseudoseptic reactions associated with hyaluronans appear relatively uncommon but can be severe. However. or disease severity. and all quotations in this section are from that report: “Results from 42 trials (N=5. those that have not been published in full text comprise approximately 25 percent of the total patient population. 2) • • “The pooled effects from poor-quality trials were as much as twice those obtained from higher-quality ones. potential publication bias.” (p.” (p. all but one synthesized in various combinations in six meta-analyses. Numbers needed to treat cannot be calculated from mean changes.” (p.” (p. Among trials of viscosupplementation. all other subgroup results were obtained in post-hoc analyses. BMI/weight.” (p. and unclear clinical significance of the changes reported. 65) “In one trial.”(p.843). 64) “Minor adverse events accompanying intra-articular injections are common. generally reported better results than other trials. 64) • “Trials of hylan G-F 20. 65) 134 . randomization was stratified by disease severity. 2) “There is evidence consistent with potential publication bias. primary/disease. the evidence on viscosupplementation is accompanied by considerable uncertainty due to variable trial quality. mean changes do not quantify proportions responding.”(p. 64) “Interpreting the clinical significance of pooled mean effects from the metaanalyses is difficult. generally show positive effects of viscosupplementation on pain and function scores compared to placebo. but was not confirmed in a subsequent trial. There was no evidence for differential effects according to subgroups defined by age. the highest molecular weight cross-linked product. but the relative risk accompanying hyaluronan injections over placebo appears to be small.Supporting Evidence This recommendation is addressed by the AHRQ report12. One positive post-hoc subgroup analysis found greater efficacy among older individuals with more severe disease. sex. Pooled results from small trials (<100 patients) showed effects up to twice those of larger trials consistent with selective publication of underpowered positive trials.

we suggest that it not be used. longer-term effects were also not statistically significant.91 (Level II RCTs) did not find any statistically significant effects at 12 weeks.90 and Ike et al. In general. stiffness. Figures relevant to this recommendation are Figure 128 – Figure 152. the Level I RCT88 (Figure 128) did not report a statistically significant effect of needle lavage on pain. Because of the lack of demonstrated effect of needle lavage. Accordingly. only one was statistically significant at 12 or 24 weeks after needle lavage.88 and this was on quality of well-being at 24 weeks. Among all of the outcomes in all of the studies. tenderness. please see evidence tables: 20 – 24. Relevant study attrition diagram shown in Appendix III. 50-foot walking time. The only statistically significant finding was reported by Bradley et al.RECOMMENDATION 17 We suggest that needle lavage not be used for patients with symptomatic OA of the knee. Dawes et al. Supporting Evidence For the raw data addressing this recommendation. or swelling at 12 or 24 weeks. function. 135 . AAOS Level of Evidence: I and II AAOS Grade of Recommendation: B Rationale: AAOS conducted a systematic review that identified one Level I RCT88 and 3 Level II RCTs89-91 that studied needle lavage in patients with symptomatic OA of the knee. Two of the studies used a sham surgical control group while the remaining two studies compared needle lavage to either medical management or arthroscopic debridement. acetaminophen use. All three Level II RCTs were graded as such due to lack of patient and caregiver blinding and failure to conceal the allocation of patients to treatment groups.

48) 91.7) 87.9 (4. 0.8 (4. mean N.4 (3. 10.88 assessed knee pain using the Likert version of WOMAC.PAIN: WOMAC Level of Evidence: One Level I RCT One RCT by Bradley et al.2 (4. Outcome Duration SMD (95% CI) (SD).9) 0 .4 (4.13. 11.05. 2002) N. 11.35 (0.46) 89.5 .6) 88. Patient pain measured by WOMAC (Bradley et al. 10.2 . 11. mean (SD).65) 89.19 (-0. Figure 128. 136 .3) 87. Sham Lavage Needle Lavage WOMAC Pain Subscale 12 weeks 0. 0. 11.9) 52 weeks 0.2) 24 weeks 0.39 .16 (-0. 0.8 Favors Sham Lavage Favors Needle Lavage *Dashed line indicates MCII for WOMAC pain.11.1 (3.

80) 0 Favors Debridement Favors Needle Lavage 137 .90) 12 months 0.10.40 (-1. Figure 129.PAIN: ARTHRIS IMPACT MEASUREMENT SCALES (AIMS) Level of Evidence: One Level II RCT Chang et al.89 assessed pain as measured by AIMS. 1.60. 0. 1993) Outcome Duration MD (95% CI) Pain: AIMS 3 months -0. Pain measured by AIMS (Chang et al.30 (-1.

Control Needle Lavage Walking Pain 12 weeks -0.5) 10.39. Figure 130. 4.50 (-1. 138 . 3.39) 10.4 (2.2 . Outcome Duration SMD (95% CI) (SD). mean N.8 Favors Needle Lavage *95% confidence interval calculated using a standard deviation estimated from range26.6 (2.5 . Walking pain measured by VAS (Dawes et al.28) 0 Favors Control .PAIN: WALKING Level of Evidence: One Level II RCT The RCT by Dawes et al. mean (SD). 0. 1987) N.90 assessed pain as it related to walking using VAS.

Pain after walking 50 feet measured by VAS (Ike et al. 1992) 10 9 8 Medical Management Tidal Knee Irrigation Visual An alog Score 7 6 5 4 3 2 1 0 0 2 4 6 8 10 12 Week *Type of error dispersion shown in the graph is not noted by authors. Figure 131. Authors report a statistically significant trend toward lower pain scores for patients receiving tidal knee irrigation using repeated measures analysis of variance (p = 0. 139 .03).PAIN: AFTER WALKING Level of Evidence: One Level II RCT The RCT by Ike et al.91 assessed pain as it related to walking using VAS.

0. Figure 132.25) 10.40) 10.39. 1987) N. 2. Pain at night measured by VAS (Dawes et al. mean (SD).90 assessed pain at night measured by VAS. 140 .2 .8 Favors Needle Lavage *95% confidence interval calculated using a standard deviation estimated from range26. Outcome Duration SMD (95% CI) (SD). Control Needle Lavage Night Pain 12 weeks -0. mean N.PAIN: AT NIGHT Level of Evidence: One Level II RCT The RCT by Dawes et al.5 .25) 0 Favors Control .9 (2. 2 (1.49 (-1.

Figure 133.4 (1. Outcome Duration SMD (95% CI) (SD). 0. mean (SD). Control Needle Lavage Rest Pain 12 weeks -0. Pain at rest measured by VAS (Dawes et al. 2.53 (-1.42. mean N. 1987) N.6 (1.36) 10. 1.5) 10.PAIN: RESTING Level of Evidence: One Level II RCT The RCT by Dawes et al.90 assessed pain at rest measured using VAS.5 .8 Favors Needle Lavage *95% confidence interval calculated using a standard deviation estimated from range26. 141 .52) 0 Favors Control .2 .

PAIN: MOST INTENSE YESTERDAY Level of Evidence: One Level II RCT Ike et al. Figure 134.02). Most intense pain yesterday measured by VAS (Ike et al. 142 . Authors report a statistically significant trend toward lower pain scores for patients receiving tidal knee irrigation using repeated measures analysis of variance (p = 0. **Dashed line indicates MCII for VAS pain defined as a 20 mm decrease from baseline.91 asked patients to assess the most intense knee pain on the day prior measured by VAS. 1992) 10 9 8 Medical Management Needle Lavage Visual Analog Score 7 6 5 4 3 2 1 0 0 2 4 6 8 10 12 Week *Type of error dispersion shown in the graph is not noted by authors.

Figure 135.PAIN: AFTER STAIR CLIMB Level of Evidence: One Level II RCT Ike et al. 1992) 10 9 8 Medical Management Tidal Knee Irrigation Visual Analog Score 7 6 5 4 3 2 1 0 0 2 4 6 8 10 12 Week *Type of error dispersion shown in the graph is not noted by authors.01).91 asked patients to rate their pain after climbing four stairs measured by VAS. Pain after climbing four stairs measured by VAS (Ike et al. 143 . Authors report a statistically significant trend toward lower pain scores for patients receiving tidal knee irrigation using repeated measures analysis of variance (p < 0.

01.5) 0 Favors Sham Lavage . 0.57) 89. Function as measured by WOMAC (Bradley et al. Sham Lavage Needle Lavage WOMAC Function Subscale 12 weeks 0. mean (SD). 40.8 (14.9 (14.28 (-0.8 Favors Needle Lavage *Dashed line indicates MCII for WOMAC function.9) 52 weeks 0.02.9 (13.5 .6) 24 weeks 0.58) 89. 41.9 (14. 37.10.37 . Outcome Duration SMD (95% CI) (SD). 37. 144 .19 (-0. Figure 136.7 (14.5) 87.9 (13.28 (-0.FUNCTION: WOMAC Level of Evidence: One Level I RCT The RCT by Bradley et al.88 assessed physical function using the Likert version of WOMAC.3) 87. mean N. 0. 42.7) 88. 2002) N.2 .49) 91. 38. 0.

10.FUNCTION: AIMS Level of Evidence: One Level II RCT The RCT by Chang et al. Figure 137. 0. 1993) Outcome Duration MD (95% CI) Function: AIMS 3 months -0.50) 0 Favors Debridement Favors Needle Lavage 145 .30 (-1. Function measured by AIMS (Chang et al.30) 12 months -0.89 assessed function measured by AIMS.50 (-1.20. 0.

13.80) 12 months 0.20) 0 Favors Debridement Favors Needle Lavage 146 .80 (-5. Patient global assessment measured by 10-cm VAS (Chang et al.60.30.20 (-10. Figure 138. 21.89 assessed global assessment measured by a 10-cm VAS. 1993) Outcome Duration MD (95% CI) Global Assessment: VAS 3 months -0.GLOBAL ASSESSMENT: VAS Level of Evidence: One Level II RCT The RCT by Chang et al.

06) 89. mean Outcome Duration SMD (95% CI) Needle Lavage (SD).GLOBAL ASSESSMENT: QUALITY OF WELL-BEING (QWB) Level of Evidence: One Level I RCT One RCT by Bradley et al. Sham Lavage QWB 24 weeks 0. mean (SD).63 (. Quality of well-being (Bradley et al.60) 87. Figure 139.05) 89.0 represents complete freedom from symptoms.8 Favors Needle Lavage 147 . .07) 52 weeks 0. 2002) N. As such.0 (optimal health). a score of 1.0 (death) to 1.88 examined patient global health status using the Quality of Well-Being (QWB) which assesses mobility.2 .36 (0.06.06) 0 Favors Sham Lavage .63 (.5 . .66) 88. 0.65 (.01. The QWB scale ranges from 0.65 (. physical and social functioning. N.31 (0. . 0. .

89 assessed physical activity measured by AIMS.40 (-3. 1993) Outcome Duration MD (95% CI) Physical Activity: AIMS 3 months -1. 0.30. Physical activity measured by AIMS (Chang et al.PHYSICAL ACTIVITY: AIMS Level of Evidence: One Level II RCT The RCT by Chang et al. Figure 140.40) 0 Favors Debridement Favors Needle Lavage 148 .30 (-3. 0.40) 12 months -1.00.

08.40) 89.20 (-2.80.20) 12 months -0.9 (29. 10. 10.4) Ike 12 weeks -0. 0. 1992) N.2) Bradley 52 weeks 0.2 . 23. 2002. 91 measured the time needed to complete a fifty-foot walk. Ike et al.1 (3. 1993) Outcome Duration MD (95% CI) 50-Foot Walk 3 months -0.2 (3.5) 87.33) 91. 50. 10.2) 0 Favors Control .80. Outcome Author Duration SMD (95% CI) (SD).22 (-0. 0. 50-foot walk measured in seconds (Bradley et al. Figure 141.80 (-2. 10.5 (2. 0. 16. mean N.2) 88.26. Control Needle Lavage 50-foot walk Bradley 12 weeks 0.18) 28. 1. 0.6) Bradley 24 weeks 0.8 (3.51) 89.foot walk measured in seconds (Chang et al.03 (-0.6 (2.10 (-0. 10. 2.19.5 (3.86.6 (4.5 .76) 29.34 (-0.50-FOOT WALK TIME Level of Evidence: One Level I RCT and one Level II RCT One Level I RCT88 and two Level II RCTs89.5) 87. 10.30) 0 Favors Debridement Favors Needle Lavage 149 . mean (SD).8 Favors Needle Lavage Figure 142.

90 measured the time needed to complete a twenty-five yard walk. 50-foot walk measured in seconds (Dawes et al. 150 . Control Needle Lavage Walkign Time 12 weeks 0.29) 0 Favors Control .25-YARD WALK TIME Level of Evidence: One Level II RCT Dawes et al.25) 10. Figure 143.5 . 103 (7.27) 10. Outcome Duration SMD (95% CI) (SD).50. mean (SD). 1.39 (-0.8 Favors Needle Lavage *95% confidence interval calculated using a standard deviation estimated from range26. mean N. 100 (8. 1987) N.2 .

mean N.01 (-0. Time needed to climb four stairs measured in seconds (Ike et al.8 (11.4-STAIR CLIMB Level of Evidence: One Level I RCT Ike et al. 11. 11.88) 0 Favors Control . mean (SD). 1992) N.3) 28.51.2 . Control Needle Lavage 4-Stair Climb 12 weeks 0. 0.5 .7 (6.8 Favors Needle Lavage 151 . Figure 144.53) 29.91 assessed the number of seconds needed to climb four stairs. Outcome Duration SMD (95% CI) (SD).

01.44) 91. 0. Stiffness as measured by WOMAC (Bradley et al.24 (-0.2) 87.29 (-0. 152 . 0.2 . 5.1) 87.4 (2.STIFFNESS: WOMAC Level of Evidence: One Level I RCT Bradley et al.59) 89.8 Favors Needle Lavage *Dashed line indicates MCII for WOMAC stiffness.1 (1.15 (-0. 5. 2002) N. 5.05.2 (1. mean N.8) 0 Favors Sham Lavage .5 . 5.39 . 5. Outcome Duration SMD (95% CI) (SD).9) 24 weeks 0.14.54) 89. mean (SD). 5. Figure 145. 0.3) 88. Sham Lavage Needle Lavage WOMAC Stiffness Subscale 12 weeks 0.7 (2.88 assessed knee stiffness using the Likert version of WOMAC.1 (1.7 (2.9) 52 weeks 0.

1992) N. Days with stiffness last week (Ike et al.12) 0 Favors Control .49 (-0.8 Favors Needle Lavage 153 .2 .5 . mean (SD). Outcome Duration SMD (95% CI) (SD).02) 29. Control Needle Lavage Stiffness: Days Previous Week 12 weeks 0.03. 5. 4.7 (2. Figure 146.9 (2.STIFFNESS: DAYS PREVIOUS WEEK Level of Evidence: One Level I RCT Ike et al.91 assessed the number of days in the previous week patients experienced knee stiffness. mean N. 1.69) 28.

89 assessed social activity as measured by AIMS.50) 0 Favors Debridement Favors Needle Lavage 154 .40 (-1.SOCIAL ACTIVITY: AIMS Level of Evidence: One Level II RCT Chang et al.70) 12 months 0. 0. 1.30 (-1. Figure 147. 1993) Outcome Duration MD (95% CI) Social Activity: AIMS 3 months -0.40.10. Social activity measured by AIMS (Chang et al.

10) 0 Favors Debridement Favors Needle Lavage 155 .80 (-1.20 (-0.80. 1. 1993) Outcome Duration MD (95% CI) Depression: AIMS 3 months 0. 0.10) 12 months -0. Figure 148.89 assessed depression as measured by AIMS.60.DEPRESSION: AIMS Level of Evidence: One Level II RCT Chang et al. Depression measured by AIMS (Chang et al.

60) 0 Favors Debridement Favors Needle Lavage 156 .30. 1993) Outcome Duration MD (95% CI) Anxiety: AIMS 3 months -0.ANXIETY: AIMS Level of Evidence: One Level II RCT Chang et al. 1. Anxiety measured by AIMS (Chang et al.30 (-1. 0. Figure 149.30.89 assessed anxiety as measured by AIMS.10 (-1.00) 12 months -0.

2 (2) 87.05 (-0.5) 0 Favors Sham Lavage .05. mean N.13 (-0.7) 88. 2. 0.7 (2. 0. 1. Sham Lavage Needle Lavage Acetaminophen 12 weeks 0.8) 24 weeks 0.43) 89.2 . 2.4 (1. Acetaminophen use measured by count (Bradley et al. mean (SD).8 (1. 0. Figure 150.24.9) 52 weeks 0.55) 89.88 assessed acetaminophen used measured by count.2 (1. 2.8 Favors Needle Lavage 157 .25 (-0.ACETAMINOPHEN USE Level of Evidence: One Level I RCT Bradley et al.35) 91. 2.6) 87. Outcome Duration SMD (95% CI) (SD).16. 2. 2002) N.1 (1.5 .

5 .8 Favors Needle Lavage 158 .68) 88. .61) 52 weeks -0. .20) 89.68) 24 weeks 0. mean N.2 .18. Sham Lavage Needle Lavage Tenderness 12 weeks 0. mean (SD).59 (.52 (.88 included a physical examination for knee tenderness.05 (-0.43 (.25.64) 87. .49 (. Figure 151. . .TENDERNESS Level of Evidence: One Level I RCT Bradley et al.56 (. 0. 2002) N.74) 0 Favors Sham Lavage .34) 91.39.11 (-0. . Knees with tenderness (Bradley et al. Outcome Duration SMD (95% CI) (SD). 0.64) 87.41) 89. 0.46 (.10 (-0.

56) 88.37) 89.49) 0 Favors Sham Lavage . . Knees with swelling (Bradley et al. 0.8 Favors Needle Lavage 159 . 2002) N.08 (-0. Outcome Duration SMD (95% CI) (SD). .55) 87. 0.SWELLING Level of Evidence: One Level I RCT Bradley et al.3 (.48 (. Sham Lavage Needle Lavage Swelling 12 weeks -0.71) 24 weeks 0.35) 89.3 (. mean (SD). . .06 (-0.34 (.33 (. mean N.24.2 . 0.88 included a physical examination for knee swelling. .5 .52) 87.47.53) 52 weeks 0.12) 91.37 (. Figure 152.17 (-0. .22.

anesthetic complications. at multiple time points from 1 week to 2 years after surgery. Supporting Evidence For the raw data addressing this recommendation. infection.RECOMMENDATION 18 We recommend against performing arthroscopy with debridement or lavage in patients with a primary diagnosis of symptomatic OA of the knee.”92 In the Level I RCT. The relevant study attrition diagram is shown in Appendix III. that was not reported by the systematic review. AAOS Level of Evidence: I and II AAOS Grade of Recommendation: A Rationale: One Level II Systematic Review92 containing three RCTs89. please see evidence tables: 25 . Similar results were found in the Level II RCTs. Figures relevant to this recommendation are: Figure 153 . 94 examined the use of arthroscopic debridement in patients with symptomatic OA of the knee. Our literature searches identified two additional Level II RCTs16. However. and who also had a concomitant diagnosis of OA of the knee. loose body. In addition. The systematic review concluded that “[arthroscopic debridement] has no significant benefit for knee OA of undiscriminated cause. and thrombophlebitis).Figure 173. additional evidence from the systematic review and the other RCTs we examined also support the lack of incremental benefit of arthroscopic debridement or lavage. Figure 166).31. 160 . which is called into question due to its limited population (largely male and veteran) and the number of potential study participants that declined randomization into a treatment group. the effects of arthroscopy with debridement or lavage were not statistically significant on the vast majority of patient oriented outcome measures for pain and function.g. One of these RCTs94 also included comparison of arthroscopic lavage alone to sham arthroscopic surgery (placebo). or other mechanical derangement. This RCT also found statistically significant effects in favor of the placebo group when compared to arthroscopic debridement on certain patient oriented outcomes (Figure 161. when considered with the increased risk due to surgery is sufficient to recommend against arthroscopic debridement and/or lavage in patients with a primary diagnosis of OA of the knee. surgical treatment subjects the patient to potentially increased risks (e. None of the evidence we examined specifically included patients who had a primary diagnosis of meniscal tear. 17 that investigated the differences between arthroscopic lavage alone and placebo. and the present recommendation does not apply to such patients. We note that there may be limited applicability of the Level I RCT. The AAOS workgroup agreed that the evidence for a lack of benefit. 93.

38 (-0.76 (0. 58.96) 28. 54 (26.8 (27. 47.6) 21. 45. 161 . (SD).84) 28.37. 0.8) Week 24 0. Pain measured by 100 mm VAS – Lavage (Ravaud et al.30. 42.7) 21.19.35) 28. mean N.27 (-0.2 .7 (28.9) 21.17. 0.3) Week 12 0. 1999) N.6) Week 4 0.5 (27.PAIN: 0-100 (VAS) Level of Evidence: One Level II RCT Ravaudet al.23 Favors Lavage Plus Placebo Injection *Dashed line indicates MCII for VAS pain. 61.19 (-0. 0.76) 28. Figure 153. 48. Lavage Plus Outcome Duration SMD (95% CI) Placebo Injection Placebo Injection Pain: 0-100 mm VAS Week 1 0.2 (26.7 (26. 53 (27.5) 0 Favors Placebo Injection .2 (21.17 reported the outcome pain (measured by 100 mm VAS) comparing arthroscopic lavage versus placebo injection (see Figure 153).8 1. 1.5 .9) 21. mean (SD).

Authors note that the improvement in VAS pain was statistically significant (p = 0.PAIN: 0-10 (VAS) Level of Evidence: One Level II RCT Pain measured by 10 cm VAS was assessed by Kalunian et al.16 (see Figure 154). 2000) 10 Minimal Irrigation Full Irrigation 8 VAS Pain Score 6 4 2 0 0 2 4 6 8 10 12 Month *Type of error dispersion shown in the graph is not noted by authors.04) favoring full irrigation including when controlling for significant covariates (p = 0. Figure 154. Pain measured by 10 cm VAS – Lavage (Kalunian et al.02). Analysis of covariance examining mean change from baseline to twelve months was compared between the two groups (minimal vs. 162 . full irrigation).

04). Figure 155. Authors note that improvement in WOMAC pain was of borderline statistical significance (p = 0. full irrigation). 163 .PAIN: WOMAC Level of Evidence: One Level II RCT Kalunian et al. Pain measured by WOMAC – Lavage (Kalunian et al.16 assessed knee pain using the Likert version of the WOMAC.05) favoring full irrigation and was statistically significant when controlling for significant covariates (p = 0. 2000) 12 Minimal Irrigation Full Irrigation 10 WOMAC Pain Score 8 6 4 2 0 0 2 4 6 8 10 12 Month *Type of error dispersion shown in the graph is not noted by authors. Analysis of covariance examining mean change from baseline to twelve months was compared between the two groups (minimal vs.

6) 57. 53.2 .9) 57. 52.8 (21.6) 55.4 (24. 53.44.56.8 (23.23 (-0.1) 59. Pain measured by AIMS – Lavage (Moseley et al. 2002) N. mean (SD).37. 57. Figure 156.07 (-0.20) 59. 0.3) 57.17 (-0.6) 56.6 (22. mean Outcome Duration SMD (95% CI) (SD).2) 56. 55.7) 54. 0. 50 (20.PAIN: AIMS Level of Evidence: One Level I RCT and one Level II Systematic Review Pain measured by AIMS was assessed by Moseley et al.8 164 .9 (23.6 (23.54.7 (24.1) 59.8 (23. 0.5 Favors Lavage .18) -0.54.94 (see Figure 156) and by Chang et al.9 (20. 0.20) -0.14) -0. Placebo N.4 (22. Lavage Pain: AIMs 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months -0.1) 59.1) 0 Favors Placebo .16 (-0. 50.7 (23.01 (-0. 0. 50.89 in a Level II systematic review92 (see Figure 157). 54.18 (-0. 0.59. 0.5 (25. 51.18 (-0. 52.38) -0. 56.3) 57. 55.19) 0.5) 57.1 (21.30) -0. 47.1) 52.53.

2008) Outcome Duration MD (95% CI) Pain: AIMS 3 months 0. 1993 in Laupattarakasem et al. 1. 1.70.Figure 157.30 (-1.10) Favors Needle Lavage 0 Favors Debridement 165 .60) 6 months 0. Pain measured by AIMS – Debridement (Chang et al.80.40 (-0.

46. 0.94 measured pain using SF-36.2) -0. 53.3 (24. 46 (22) 0. mean Outcome Duration SMD (95% CI) (SD). 0.36) 56.9) 59. 44. 44.8 *Dashed line indicates MCII for SF-36 pain.3 (26. Figure 158. 0.4) 0 Favors Placebo .7 (19.14 (-0.2 .47 Favors Lavage .6 (24.77) 59.4) 59.9 (24.41) 54.03 (-0.01 (-0. 46. mean (SD).9) 57. 42.1) -0. 49. 0. 2002) N.04. Placebo N. 44.2) 57.4 (24.21 (-0. 0.16. Lavage Pain: SF-36 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months 0.6 (24.52.3) 57. 47. 166 .1) 0. 45.34.1 (21.4 (22. 43.40 (0.PAIN: SHORT FORM-36 HEALTH SURVEY QUESTIONNAIRE (SF-36) Level of Evidence: One Level I RCT Moseley et al.1) 59. 40.38) 57. 42.8 (23.46.8 (24.58) 57.7) 0.8) 57.37. Pain measured by SF-36 – Lavage (Moseley et al.09 (-0.23) 52. 0.2 (21.01 (-0.8 (21.9) -0. 0.35.28) 55.

51. 50. mean Outcome Duration SMD (95% CI) (SD). Pain measured by KSPS – Lavage (Moseley et al.54) 59.5 Favors Lavage .18 (-0.56) -0.5) 57.7 (23.44) 0.1) 52.7) 54.1) 59. 57. 0. 53. 55.7 (24. 52. 47.54) 0.PAIN: KNEE SPECIFIC PAIN SCORE (KSPS) Level of Evidence: One Level I RCT and One Level II Systematic Review Pain measured by the Knee Specific Pain Score (KSPS) was assessed by Moseley et al.9) 57. 0.18 (-0. Lavage Pain: KSPS scale 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months 0.6 (22.6) 57.4 (24. 0.59) 0.1) 59.01 (-0.8 (23. 50 (20.1) 59.9 (23.8 167 .14.8 (21.2) 56. 50. 54.6) 55.4 (22. 0.94 (see Figure 159). 56.07 (-0. Figure 161). 52.19.38. Figure 159.16 (-0. 55.2 .23 (-0.18.53) 0. 0.5 (25.3) 57.30. 2002) N. 0. 53.9 (20.17 (-0.8 (23.20. 0.6 (23.3) 57.1) 0 Favors Placebo .6) 56.20.37) 0. A Level II systematic review92 examining debridement also included the Moseley RCT (see Figure 160.1 (21. Placebo N. mean (SD).

2) 0 Favors Lavage .18 (-0.4 (22.48.34) -0.09 (-0.23) 0. Pain measured by KSPS – Debridement & Lavage (systematic review Laupattarakasem et al.26) 0. 45.2 .28. Debridement Pain: KSPS scale 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months -0.3 (23) 58.13 (-0. mean (SD).6 (23.5) 59. 53.07 (-0.15 (-0.45 (-0.45) 0. mean Outcome duration SMD (95% CI) (SD).8 168 .46) 0.23.51) 0.48) 59. 54.3 (23) 58.32.5) 57.4) 55. 51. 52.9 (20. 0.22. 49.8 (21.1 (19. 54. 49. 0. 0.51. 53.5 Favors Debridement . Pain measured by KSPS – Debridement (systematic review Laupattarakasem et al.7 (21. 49. 0. 50 (21) 50. 50.1 (20.16 (-0. 0.6 (20.20) -0. 51. 2008) N.8 Figure 161. 53.28.7 (22.3 (22) 56. 48.4 (23.39.2 .7) 59.7) 55. 0.54) 0.02 (-0.13 (-0.3) 53. 54.5) 57.9 (21. 2008) N.49.7 (23. Lavage N. Placebo N. 0. 50.5) 57.7 (22. 0.19. 0.39) 59. -0.7) 59. 50 (21) 50. 0.1 (22.8 (19.2) 0 Favors Placebo .3 (22) 56.8) 56.2 (22.40) 0. 51. 48. 45.7 (25.15 (-0. 51.6) 57.9) 52.6 (18. 52.5) 59.36.4 (23.25) -0. mean (SD). 49.02 (-0. 0.53) 0.7) 53.81.5 Favors Debridement . 51. 51.12 (-0. 47. 51.7 (25.53.3) 53.7) 59.4) 59. 0.Figure 160.08) -0.10 (-0.37.2 (20. Debridement Pain: KSPS scale 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months -0.7) 56.4) 51. mean Outcome duration SMD (95% CI) (SD).01 (-0.4) 51. 0.6 (18.

14) 32/40 5/36 60 months 11. 45.20) 19/32 3/26 .21 (2. Figure 162. Outcome duration OR (95% CI) Debridement Lavage Pain free 12 months 24. 84.PAIN: FREE FROM Level of Evidence: One Level II Systematic Reviews A Level II systematic review92 included a RCT93 assessing the number of patients reporting their knee to be free from pain. 1 Favors Lavage Favors Debridement 169 .80 (7. Patients with pain free knees – Lavage & Debridement (systematic review Laupattarakasem et al. 2008) Events.31.78. Events.

10. N.5) 21.40 (-0.17.13.5) 21.13. 8.6) Week 12 0.8 (4.6 (4. mean (SD).9 (5. 8. 9.44 (-0.5 .4 (4.3) 21.3) 21.2 . 1.84) 28. Function measured by Lequesne Index – Lavage (Ravaud et al.44 (-0. Figure 163.01) 28.5) Week 24 0.17 (see Figure 163). 0.8) 0 Favors Placebo Injection .8 Favors Lavage Plus Placebo Injection 170 .2) Week 4 0.1 (4. 10.97) 28.02) 28. mean (SD). 1999) N.FUNCTION: LEQUESNE Level of Evidence: One Level II RCT Function measured by Lequesne Index was assessed by Ravaud et al.6 (4. 0.30. 8.27 (-0. 1. 10.4 (4. Lavage Plus Outcome Duration SMD (95% CI) Placebo Injection Placebo Injection Lequesne's Index Week 1 0. 8.1 (4.

46) 55.17 (-0.72) 50.60) 57.4 (20. 51. 48. 45. Physical Functioning Scale – Lavage (Moseley et al. 48. 53. mean Outcome Duration SMD (95% CI) (SD).FUNCTION: PHYSICAL FUNCTIONING SCALE (PFS) Level of Evidence: One Level I RCT Moseley et al. 0.5 (19.72) 54.23. 0.94 devised a Physical Functioning Scale (PFS).4) 44.24.7 (12) 0 Favors Placebo .10. 48.06. mean (SD).13. 0.57) 49.4) 0.33 (-0. Lavage N. 0.6) 0.30.5 (12.31 (-0.23 (-0. 49.6 (10.9 (12) 54. 0. 45. 0.2 .14 (-0.3 (13. 47 (13) 49.8 (21) 0.22 (-0.6) 59. 47. Figure 164.2) 46.4) 56.08 (-0. Patients were required to walk 30 meters and to climb up and down a flight of stairs as quickly as possible with longer times indicating poorer function.60) 54.3) 0.3 (16) 54. Placebo Physical Functioning Scale 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months 0.8 171 . 49.2 (18.5 Favors Lavage .15.2 (21. 47. 50.4) 0.4 (17. 53 (25.8) 0. 2002) N. 0.52) 52.

5 (19.49.28) -0. 48.37.4 (20. This appears to be a labeling error on the part of Laupattarakasem et al. 49.8) 50.8 (17. mean Outcome duration SMD (95% CI) (SD). the data reported corresponds to the Physical Function Scale tabled in the original Moseley et al.7) 56. 56 (21.4) 54.4) 55. 0.2 .33) 0.9) 44.34) -0. 53.2 (18. 52.5 (20.13 (-0.6) 57.8) 47.3) 44. 53 (25.47. 50. 51.10 (-0.” however.8 **Laupattarakasem et al (2008) report the above data as “Physical Function AIMS.5 (17.4) 54.50. 49.02 (-0.7 (24. 2002 in Laupattarakasem et al.11 (-0.8 (20.36) -0. 0.44) 57. mean (SD).24) -0. (2002) study. 52. 49.3) 54. 52.03 (-0.27) -0. 2008) N.6) 49.2 (21.49.89. (Figure 164) 172 .40. 94 Figure 165.5 Favors Debridement .08 (-0. 51.4 (17. 0.4) 0 Favors Lavage . Debridement Physical function: AIMS scale 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months -0. 0. 0. Physical function measured by AIMS** – Debridement & Lavage (Moseley et al.6 (16.8 (21) 52.8) 58. 0.04 (-0.FUNCTION: AIMS Level of Evidence: One Level II Systematic Review Function measured by AIMS was assessed in a Level II systematic review92 which included two RCTs. 0. 49.41. Lavage N.

08) 59.13 (-0.51.07) -0.18 (-0. Physical function measured by AIMS** – Debridement (Moseley et al.25 (-0.6 (16.80.2) 46.5 Favors Debridement .67. 173 . 49. mean (SD).7) 56.8 **Laupattarakasem et al (2008) report the above data as “Physical Function AIMS.16) -0. 2008) N. 47.06) -0. 52. 0. the data reported corresponds to the Physical Function Scale tabled in the original Moseley et al.7 (12) 57.4) 0 Favors Placebo .Figure 166.5 (12.3 (16) 54.30 (-0.” however.8 (17.6 (10.43 (-0. 45.9 (12) 54. -0. This appears to be a labeling error on the part of Laupattarakasem et al.4) 56. 47.80.4) 58. 47 (13) 49. 51. 0.8) 58.4) 54. 52. 56 (21. 48.42 (-0.20) -0.9) 44. 2002 in Laupattarakasem et al.56.24) -0. mean Outcome duration SMD (95% CI) (SD). 0. -0.3) 44.3 (13. 49.7 (24.76.5 (17.03) -0. 48. 0.5 (20. (2002) study. Placebo N. 45.2 .4) 44. Debridement Physical function: AIMS scale 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months -0. 0.67. 52.34 (-0. (Figure 164).8 (20.

50 (-0.Figure 167.20. 2008) Outcome Duration MD (95% CI) Function: AIMS 3 months 0. 1993 in Laupattarakasem et al.30 (-0. 1. Physical function measured by AIMS – Debridement (Chang et al.10) Favors Needle Lavage 0 Favors Debridement 174 .50. 1.20) 6 months 0.

Analysis of covariance examining mean change from baseline to twelve months was compared between the two groups (minimal vs. Authors do not note if WOMAC function is significant when not controlling for covariates. 2000) 35 Minimal Irrigation 30 WOMAC Function Score 25 20 15 10 5 0 0 2 4 6 8 10 Full Irrigation 12 Month *Type of error dispersion shown in the graph is not noted by authors. Improvement in WOMAC function was not statistically significant when controlling for statistically significant covariates (p = 0. 175 . Function measured by WOMAC – Lavage (Kalunian et al.FUNCTION: WOMAC Level of Evidence: One Level II RCT Kaluninan et al. full irrigation). Figure 168.16 assessed knee function using the Likert version of the WOMAC.15).

176 . 48.07 (-0. 49 (27.01 (-0.36) -0. 52. 0. Placebo N.03 (-0. Lavage Function: SF-36 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months -0. 0.38.5) 52. 52.17 .19 (-0.1 (23.3 (24. 49.40. 53.4 (25.94 assessed function as measured by SF-36. 50.2 (26.5) 57. 51 (24. 0. Patient function measured by SF-36 – Lavage (Moseley et al.3) 0 Favors Placebo .5 Favors Lavage . mean (SD).8) 57.30.45) -0.30) 59.1 (25) 54.18) -0.15 (-0.08 (-0.6 (23.4) 57. 2002) N.4 (27. 51. 0.3) 57. 50 (28) 57.2) 59.02 (-0.6) 57. 0.51. 47 (28.FUNCTION: SF-36 Level of Evidence: One Level I RCT Moseley et al. 0.7) 59.4 (23. 53.44.9) 54.8 *Dashed line indicates MCII for SF-36 function.35) 0. 50.39.21) -0.2) 56. 0. 49.6) 59.9 (27.9 (26.35) -0. mean Outcome Duration SMD (95% CI) (SD).55. Figure 169.

18. 50.97) 28.1 (30) 21.98) 28. 48.18 (-0.2) 21.75) 28.2) Week 4 0.8 1 Favors Lavage Plus Placebo Injection *Dashed line indicates MCII for global assessment (VAS).1 (31. 60.9) Week 24 0.3 (29.00. 177 .1 (30.58 (0.8) Week 12 0.41 (-0. Lavage Plus Outcome Duration SMD (95% CI) Placebo Injection Placebo Injection Global Assessment: VAS Week 1 0. 0. 44 (30.5 . 57. (SD). 62 (28.17 (see Figure 170). mean N.38.6) 21.39 (-0. 1999) N.1 (25. 51.3) 21.2 . 1. Global assessment measured by VAS – Lavage (Ravaud et al.16) 28.5 (29.16. 0. Figure 170. mean (SD). 0.GLOBAL ASSESSMENT (VAS) Level of Evidence: One Level II RCT Global assessment measured by VAS was assessed by Ravaud et al.3) 0 Favors Placebo Injection . 60.

16 examined aggregate WOMAC scores defined as the sum of the pain. 178 . 2000) 50 Minimal Irrigation Full Irrigation Aggregate WOMAC Score 40 30 20 10 0 0 2 4 6 8 10 12 Month *Type of error dispersion shown in the graph is not noted by authors. Authors note that the aggregate WOMAC score was not significant (p = 0.13) nor was it significant when controlling for significant covariates (p = 0. full irrigation). Aggregate WOMAC – Lavage (Kalunian et al. Figure 171. stiffness and function WOMAC subscores.AGGREGATE WOMAC Level of Evidence: One Level II RCT Kalunian et al.10). Analysis of covariance examining mean change from baseline to twelve months was compared between the two groups (minimal vs.

6 (26.6) 55.6) 57.2 (28.7 (31.8 179 . 47. 53.37) 0.5) 59. 0.3 (22.94 assessed walking-bending as measured by AIMS.01) 0.3) 56. 0.9 (30. mean (SD). 2002) N. Figure 172. 51. Walking-bending measured by AIMS – Lavage (Moseley et al.47) 59. 0.9) 57.3) 0 Favors Placebo . 49.72.4) 57.8) 53.44) 0.5 Favors Lavage .18 (-0. 0. 47.1) 59.01 (-0.6 (29. 0. 0. 50. 49. 0.1 (28.9 (27. 47.37) 0.36.35 (-0.01 (-0.8) 59.38) -0. 47.35. 49.10 (-0.2 . 57. 48. Placebo N.00 (-0.9 (21.28.1) 56. mean Outcome Duration SMD (95% CI) (SD).8 (27.08 (-0.4 (25.38.1 (25.56) 0. 55.5) 52. Lavage Walking-Bending: AIMS 2 weeks 6 weeks 3 months 6 months 12 months 18 months 24 months -0.5 (26.WALKING-BENDING (AIMS) Level of Evidence: One Level I RCT Moseley et al.6) 57.5 (28.29.19.5) 55. 49.

180 . Knee stiffness measured by WOMAC – Lavage (Kalunian et al.STIFFNESS: WOMAC Level of Evidence: One Level II RCT Kalunian et al. Authors note that improvement in WOMAC stiffness was not statistically significant (p = 0. Analysis of covariance examining mean change from baseline to twelve months was compared between the two groups (minimal vs.16 assessed knee stiffness using the Likert version of the WOMAC.22).32) nor was it significant when controlling for statistically significant covariates (p = 0. Figure 173. full irrigation). 2000) 5 Minimal Irrigation Full Irrigation 4 WOMAC Stiffness Score 3 2 1 0 0 2 4 6 8 10 12 Month *Type of error dispersion shown in the graph is not noted by authors.

Additional studies are warranted to look at the outcomes of arthroscopic surgery in this population. The expert opinion consensus of the AAOS workgroup is that arthroscopic partial meniscectomy or loose body removal is an option for patients with primary signs and symptoms a torn meniscus and/or loose body. No studies were identified by our systematic literature review specific to this patient population. There is no evidence available to suggest that arthroscopic partial meniscectomy and/or loose body removal is or is not appropriate for a patient with a primary diagnosis of a torn meniscus and/or a loose body.RECOMMENDATION 19 Arthroscopic partial meniscectomy or loose body removal is an option in patients with symptomatic OA of the knee who also have primary signs and symptoms of a torn meniscus and/or a loose body. in which OA of the knee is identified secondarily. 181 . AAOS Level of Evidence: V AAOS Grade of Recommendation: C Rationale: Currently. arthroscopic partial meniscectomy and/or loose body removal are routinely performed in patients with symptomatic OA of the knee who also have primary signs and symptoms of a torn meniscus and/or a loose body. Supporting Evidence: No studies investigating the use of arthroscopic partial meniscectomy and/or loose body removal in patients with a primary diagnosis of a torn meniscus and/or intra-articular loose body and secondary OA of the knee were identified by our systematic literature searches.

RECOMMENDATION 20 We cannot recommend for or against an osteotomy of the tibial tubercle for patients with isolated symptomatic patello-femoral osteoarthritis. 182 . specific to patients with isolated patello-femoral OA of the knee or of patients receiving an osteotomy of the tibial tubercle. AAOS Level of Evidence: V AAOS Grade of Recommendation: Inconclusive Rationale: Osteotomy of the tibial tubercle has been proposed as a treatment for patients with isolated symptomatic patello-femoral OA of the knee. No studies were identified by our systematic review processes. Supporting Evidence: No studies investigating osteotomy of the tibial tubercle for patients with isolated patellofemoral OA were identified by our systematic literature searches.

the workgroup qualified this recommendation for “active” patients using Level V expert opinion. please see evidence tables: 32 . 183 . Additionally. The AAOS workgroup agreed that the Level IV case series evidence suggested that realignment osteotomy had benefits that lasted up to two years after surgery. Supporting Evidence For the raw data addressing this recommendation. function. is considered Level IV because there is no comparison to a placebo or control group. Clinically important and statistically significant differences from baseline (pre-operative) were found for pain. To address efficacy. we examined five case series studies 96-100 and the baseline and follow up measurements within each treatment arm of six RCTs. symptoms. and quality of life as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) 2 years96 after the procedure.103 and the WOMAC instrument104 one year after the procedure. The remaining case series consistently shows statistically significant differences from baseline but cannot be evaluated for clinical importance. including the pre. This systematic review concludes that there is limited evidence for the efficacy of osteotomy. Figures relevant to this recommendation are Figure 174 – Figure 196. and stiffness as measured by the WOMAC instrument one year104 after the procedure and for pain. activities of daily living. Instead it compared various realignment osteotomy operative techniques. Possibly clinically important and statistically significant differences from baseline were found for pain measured by VAS.RECOMMENDATION 21 Realignment osteotomy is an option in active patients with symptomatic unicompartmental OA of the knee with malalignment.101-106 This evidence. but did not specifically address the efficacy of realignment osteotomy. We did not analyze longer-term results because of loss of patients in the relevant studies.and post-operative data from RCTs. AAOS Level of Evidence: IV and V AAOS Grade of Recommendation: C Rationale: A systematic review investigated realignment osteotomy in patients with unicompartmental knee OA with malalignment.35. The relevant study attrition diagram is shown in Appendix III. Complications or adverse events varied among surgical techniques reported by the case series evidence. comparing different operative techniques.95 This review examined various osteotomy operative techniques. function.

Figure 174: Mean VAS Pain Score in closing wedge HTO (Brouwer et al.PAIN: VAS Level of Evidence: Level IV case series evidence from one RCT Brouwer et al.001 95% confidence interval calculated from estimated standard deviation. 26 VAS Pain Score VAS Pain Score 184 .001 95% confidence interval calculated from estimated standard deviation. 26 Figure 175: Mean VAS Pain Score opening wedge HTO (Brouwer et al. 2006) 10 8 6 4 2 0 Baseline 1 Year Post Operative MCII Change from baseline: p<0. 2006) 10 8 6 4 2 0 Baseline 1 Year Post Operative MCII Change from baseline: p<0.103 presents level IV case series evidence examining pain using a Visual Analog Scale (VAS) at baseline and one year after closing wedge osteotomy or opening wedge osteotomy. Baseline and post procedure VAS pain mean scores within each group are shown in Figure 174 and Figure 175.

96 measured pain at baseline and 2 years postoperatively in patients receiving hemicallotasis osteotomy using the pain subscale of the Knee Injury and Osteoarthritis Outcome Score (KOOS). Figure 176: Mean KOOS Pain Score (Dahl et al.001 185 .PAIN: KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE (KOOS) Level of Evidence: One Level IV case series study Dahl et al. Pain relief reached both clinical and statistical significance. 2005) Mean KOOS Pain (1000 Best-Worst) 100 80 60 40 20 0 MCII Baseline 2 Years Post Operative Change from baseline: p < .

104 reported the WOMAC pain scores in patients with Ilizarov or Coventry HTO at baseline and 12 months post surgery.032 186 .2002) WOMAC Pain Score 20 15 10 5 0 Baseline 1 Year Post Operative MCII Change from baseline: p <.PAIN: WOMAC Level of Evidence: Level IV case series evidence from one RCT Adili et al. 2002) 15 WOMAC Pain Score 10 5 0 Pre Operative MCII 1 Year Post Operative Change from baseline: p =.0001 Figure 178: Mean WOMAC Pain Score Coventry HTO (Adili et al. Figure 177 WOMAC Pain Score Ilizarov HTO (Adili et al.

5 Months Post Operatvie Change from baseline in both OWO and CWO groups: p < .PAIN: PERCENT OF PATIENTS WITH PAIN AT REST AND WHILE WALKING Level of Evidence: Level IV case series evidence from one RCT Hoell et al.5 Months Post Operatvie CWO Percent of Patients Reporting Pain at Rest 60 40 20 0 PreOperative 22. Figure 179: Percent of Patients with Pain at Rest (Hoell et al. 2004) OWO Percent of Patients Reporting Pain at Rest 40 30 20 10 0 PreOperative 22.106 reported the percent of patients with pain while resting and pain while walking both before surgery and 22.05 187 .5 months post surgery after receiving either opening wedge osteotomy or closed wedge osteotomy.

2004) OWO 100 Percent of Patients with Pain While Walking 80 60 40 20 0 PreOperative CWO 100 80 60 40 20 0 22.05 188 .5 Months Post Operative Change from baseline in both OWO and CWO groups: p <.5 Months Post Operative Percent of Patients with Pain While Walking PreOperative 22.Figure 180: Percent of Patients with Pain While Walking (Hoell et al.

5 Months Post Surgery 100% Percent of Patients 80% 60% 40% 20% 0% 82% 82% OWO CWO 189 .PAIN: PERCENT OF PATIENTS WITH IMPROVEMENT IN PAIN Level of Evidence: Level IV case series evidence from RCT Figure 181: Percent of Patients with Improvement in Pain. 2004) Pain Improvement 22. (Hoell et al.

2002) 100% Percent of Patients 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Les s than 50%Pain Relief 50%-75% Pain Relief 75%-100% Pain Relief 2 Years Post Operative 6 Years Post Operative Change from 2 to 6Years is statistically significant in 75-100% pain relief group (OR = 2.39).22 . 190 . 50-75%. or less than 50% reduction in pain at 2 years and 6 years. Figure 182: Percent of Patients with Reduction in Pain using VAS Scale (Devgan et al.78. CI = 1.98 reported the percent of patients with 75-100%.PAIN: PERCENT OF PATIENTS WITH REDUCTION IN PAIN Level of Evidence: One Level IV case series study Devgan et al.6.

2002) W OMAC Stiffness Score 8 6 4 2 0 Pre Operative Operative 1 Year Post MCII Change from baseline p = . 2002) W AC Stiffness Score OM 8 6 4 2 0 Pre Operative 1 YearPost Operative MCII Change from baseline p=.48 191 .003 Figure 184: Mean WOMAC Stiffness Score Coventry HTO (Adili et al.STIFFNESS: WOMAC Level of Evidence: Level IV case series evidence from one RCT Adili et al. Figure 183: Mean WOMAC Stiffness Score Ilizarov HTO (Adili et al.104 reported the WOMAC stiffness scores in patients with Ilizarov or Coventry HTO at baseline and 12 months post surgery.

FUNCTION: WOMAC Level of Evidence: Level IV case series evidence from one RCT Adili et al.104 reported the WOMAC function scores in patients with Ilizarov or Coventry HTO at baseline and 12 months post surgery. 2002) W M CF c O A un tion S ore c 68 58 48 38 28 18 8 -2 MCII Pre Ope rative 1 Ye ar Pos t Ope rative Change from baseline p =.02 192 . Figure 185: Mean WOMAC Function Score Ilizarov HTO (Adili et al. 2002) W AC Function Score OM 68 58 48 38 28 18 8 -2 Pre Ope rative 1 Year Pos t Ope rative MCII Change from baseline p <.001 Figure 186: WOMAC Function Score Coventry HTO (Adili et al.

2005) 100 Mean Symptoms KOOS (100-0 BestWorst) 80 60 40 20 0 MCII Baseline 2 Years Post Surgery Change from baseline p < . Figure 187: Mean Symptoms KOOS (Dahl et al. Symptoms were measured using the symptom subscale of the Knee Injury and Osteoarthritis Outcome Score.96 measured OA symptoms at baseline and 2 years postoperatively in patients receiving hemicallotasis osteotomy.SYMPTOMS: KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE Level of Evidence: One Level IV case series study Dahl et al.001 193 .

ADL was measured using the activities of daily life subscale of the Knee Injury and Osteoarthritis Outcome Score. Figure 188: Mean Activities of Daily Life KOOS (Dahl et al. 2005) Mean Activities of Daily Life KOOS (1000 Best-Worst) 100 80 60 40 20 0 I MCII Baseline 2 Years Post Operative Change from baseline p < .96 measured the level of activities of daily life (ADL) at baseline and 2 years postoperatively in patients receiving hemicallotasis osteotomy.001 194 .ACTIVITIES OF DAILY LIFE: KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE Level of Evidence: One Level IV case series study Dahl et al.

2005) Sport and Recreation Function KOOS (100-0 Best-Worst) 100 50 MCII 0 Baseline 2 Years Post Surgery Change from baseline p < . Figure 189: Mean Sports and Recreational Function Score KOOS.This was accomplished using the sports and recreational function subscale of the Knee Injury and Osteoarthritis Outcome Score. (Dahl et al.SPORTS AND RECREATIONAL FUNCTION: KNEE INJURY AND OSTEOARTHRITIS OUTCOME SCORE Level of Evidence: One Level IV case series study Dahl et al.001 195 .96 measured the level of sports and recreational function at baseline and 2 years postoperatively in patients receiving hemicallotasis osteotomy.

2005) Knee Related Quality of Life KOOS (100-0 Best.Worst) 80 60 40 I 20 0 MCII Baseline 2 Year Post Operative Change from baseline: p < . Figure 190: Knee Related Quality of Life KOOS.001 196 .96 measured the knee related quality of life (QoL) at baseline and 2 years postoperatively in patients receiving hemicallotasis osteotomy. (Dahl et al. QoL was measured using the knee related quality of life subscale of the Knee Injury and Osteoarthritis Outcome Score.KNEE RELATED QUALITY OF LIFE: KOOS Level of Evidence: One Level IV case series study Dahl et al.

103 measured walking distance at baseline and one year post surgery.05 OW p<. The author of this study did not provide a specific description of the test used to measure walking distance.WALKING DISTANCE Level of Evidence: Level IV case series evidence from one RCT Brouwer et al. 2006) Mean Walking DistanceKM 8 6 4 2 0 Baseline 1 1 Year Follow up Closing Wedge Change from baseline: CW p = <. Figure 191: Mean Walking Distance (Brouwer et al.05 Opening Wedge 95% confidence interval calculated from estimated standard deviation 26 197 .

99 reported the mean Lysholm score at baseline and 16 months postoperatively.105 examined the mean Lysholm scores before and two years following the procedure within both treatment arms. pain.LYSHOLM SCORE Level of Evidence: One Level IV case series study and Level IV case series evidence from two RCTs The Lysholm function score considers patient limp. walking.001 HCO p < . Magyar et al. 2001) Mean Lysholm Score (0-100 Worst to Best) 100 80 60 40 20 0 Baseline 16 Months Post Operation Change from baseline: p < . 198 . Klinger et al. Figure 193: Mean Lysholm Scores (Magyar et al. squatting. swelling.05 95% confidence interval calculated from estimated standard deviation and mean estimated from median 26. Figure 192: Mean Lysholm Score (Klinger et al. and thigh atrophy. running and jumping.001 95% confidence interval calculated from estimated standard deviation and mean estimated from median 26. 1999) Mean Lysholm Score 100 80 60 40 20 0 Pre Operative Two Year Follow Up Closing Wedge Opening Wedge Change from baseline: HTO p <.

Hoell et al.106 recorded the mean Lysholm score in both the opening wedge osteotomy group and closed wedge osteotomy group preoperatively and 22.5 Months Post Operative CWO Change from baseline: OWO p < . 2005) 50 Mean Lysholm Score 40 30 20 10 0 Pre Operative OWO 22.01 CWO p < . Figure 194: Mean Lysholm Score (Hoell et al.5 months post operatively.05 199 .

Figure 195: Patient Opinion of Results (Myrtnets et al. 1 or 2 years after the surgery.101 asked patients their opinion of the results of the operation at the final follow-up exam. 1980) 100 80 60 40 20 0 Worse than Before Same as Before A Little Much Better No Pain at Better Than Than Before All Before Percent of Patients 200 .PATIENT OPINION OF RESULTS Level of Evidence: Level IV case series evidence from one RCT Myrnerts et al.

(Naudie et al.100 evaluated 106 osteotomies in 78 patients.53) 201 .44-4. 1999) 100% Percent Survival 80% 60% 40% 20% 0% 0 2 4 6 Years Since Surgery 8 10 12 Statistically significant change in percent of survival from 5-10 years (OR= 2.SURVIVAL Level of Evidence: One Level IV case series study Naudie et al.57 95% CI= 1. The percent of survival of osteotomy at 5 and 10 years is reported in Figure 196 Figure 196: Percent Survival.

Table 13. 1980 101 Adili et al. 2002 104 Magyar et al 1999 105 Adili et al. 2006 103 202 . Complication or adverse event rates ranged from 1 percent to 43 percent. 2006 103 Adili et al. Complications and Adverse Events exceeding 10% of Enrolled Patients Complication or Adverse Event Percentage of Patients Study Medial Joint Pain Removal of Osteosynthesis Material Minor Infection Grade 2 Pin Site Infection Pin/Wire Removal due to Infection Revised with Arthroplasty Reoperation Deep Vein Thrombosis Ankle Stiffness Loose Pin(s) Grade 2 Pin Site Infection Iliac Crest Morbidity 43% 41% 40% 33% 23% 20% 18% 17% 17% 12% 10% 10% Adili et al. 2002 104 Dahl et al. 2002 104 Naudie et al. 2002 104 Adili et al. Evidence Table 40 contains all complications or adverse events reported in the eleven studies investigating osteotomy in patients with uni-compartmental knee OA with malalignment. Table 13 below shows complications or adverse events which exceeded 10 percent of the enrolled patients. 2002 104 Brouwer et al. 1999 100 Myrnerts et al.COMPLICATIONS OR ADVERSE EVENTS Level of Evidence: IV 5 Level IV case series studies and Level IV case series evidence from 6 RCTs Complications or adverse events reported by study authors varied considerably. 2005 96 Brouwer et al. 2005 96 Dahl et al.

RECOMMENDATION 22 We suggest against using a free-floating interpositional device for patients with symptomatic unicompartmental OA of the knee. We categorized this evidence as Level IV evidence. based on the high revision rates in these series.38. Differences from baseline on the Knee Society Function Score were statistically significant and remained “poor” post-operatively (Figure 199). 203 . The relevant study attrition diagram is shown in Appendix III.108-110 reporting the results of free-floating interpositional device surgeries performed between 2004 and 2006. The AAOS workgroup upgraded this recommendation to grade B. the Australian Joint registry stated that they no longer use free-floating interpositional devices. Figures relevant to this recommendation are Figure 197 . Supporting Evidence For the raw data addressing this recommendation.111 The evidence demonstrates high reoperation rates in the patients followed in both series.Figure 202. Revision to total knee arthroplasty ranged from 32 percent at 2 years to 62 percent at 3 years. addresses the use free-floating interpositional devices for treatment of unicompartmental OA of the knee. (Figure 201. please see evidence tables: 36 . In 2007. Figure 202) The evidence demonstrates differences from baseline that are not clinically important and statistically significant for pain measured on VAS 2 years postoperatively (Figure 197). AAOS Level of Evidence: IV AAOS Grade of Recommendation: B Rationale: Evidence from one published case series107 and from the Australian Orthopaedic Association Joint Registry. and the potential harm associated with this intervention.

PAIN: VAS Level of Evidence: One Level IV case series study Sisto et al.001 204 .107 measured pain using a VAS scale at baseline and at 24 months (range 22-26 months).9 mm change measured by VAS for pain is considered clinically important.21 Figure 197: Mean Pain Scores (VAS) (Sisto et al. 2005) 30 Mean Pain Score 25 20 15 10 5 0 PreOperative 2 Years Post Operative Change from baseline: p=. A 19.

PAIN: PRESENCE WHILE WALKING Level of Evidence: One Level IV case series study Sisto et al. Figure 198: 26 Months Post-Operative Presence of Pain While Walking (Sisto et al. 2005) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Presence of Pain No Pain Percent of Patients 205 .107 recorded the number of patients who complained of pain while walking 24 (range 22-26) months after surgery.

0001 206 .FUNCTION: KNEE SOCIETY SCORE Level of Evidence: IV One Level IV case series study Sisto et al. 2005) 100 90 80 70 60 50 40 30 20 10 0 Pre Operative 24 Months Post Operative Change from baseline: p<0. 2005) Mean Knee Society Objective Score Mean Knee Society Function Score 100 90 80 70 60 50 40 30 20 10 0 Pre Operative 24 Months Post Operative Change from baseline p<. Figure 199: Mean Knee Society Function Score (Sisto et al.107 compare the pre and post surgery scores for both the Function and Objective Scores.001 Figure 200: Mean Knee Society Objective Scores (Sisto et al.

Sisto et al. The Australian Joint Registry110 reported 39 free-floating interpositional device procedures between 2004 and 2006. (Sisto et al.4 Figure 202: Percent Revised to TKA.REVISION RATE Level of Evidence: One Level IV case series study and Level IV evidence from joint registry data Two case series report revision rate after free-floating interpositional device procedures. 2006) Percent Revised to TKA 100 80 60 40 20 0 0 1 2 3 ince Since Surgery Years SYears Uni-Spacer Surgery 4 41 59 62. 2005) 100% 90% Percent of Patients 80% 70% 60% 50% 40% 30% 20% 10% 0% Revised to TKA Not Revised to TKA 207 .107 reported the revision rate of 37 freefloating interpositional devices arthroplasties in 34 patients. Figure 201: Cumulative Percent of Revisions (Australian Joint Registry.

To achieve a high quality literature base. The use of validated patient oriented outcome measures will ensure that the measure of success of future studies is determined by minimal clinically important improvements. academic authors and scientists should invest their time and effort in studies designed to avoid bias. Future studies should also include a priori power analysis to ensure clinically important improvements (improvement that matters to the patient). in some cases. or severity of the OA). Techniques to limit bias include proper randomization and adequate. non-placebo control groups should be considered. wherever possible. the use of active. High quality evidence for surgical treatment (up to but not including knee arthroplasty) of OA of the knee is generally lacking. SF-36) whose key psychometric characteristics have been evaluated and validated. These studies should utilize patient oriented outcome measures (i. verified blinding of investigators. WOMAC. Investigators should develop rigorous patient inclusion criteria to ensure that patients that typically receive the surgical intervention in clinical practice are adequately represented in the study population.e. meniscal tear) in addition to the symptoms from OA of the knee.FUTURE RESEARCH Many treatments for OA of the knee are addressed by randomized controlled trials. To improve the quality of future studies of operative treatments. activity level. The logistical difficulties and ethical concerns in conducting placebo controlled studies of operative interventions compromise the quality of these studies. The quality of these trials is. questionable. 208 . loose body.e. and/or evaluators.e. patients. Surgical treatments for OA of the knee are often indicated in patients exhibiting unique symptoms from other pathologies (i. or in patients with a specific characteristics (i. age.

APPENDIXES 209 .IV.

#2 Airmont. MD Department of Orthopaedics Seattle Children’s Hospital 4800 Sand Point Way NE Seattle. MD Rockland Orthopedics & Sports Medicine 327 Route 59. IL 60018 Daniel Van Durme MD Dept. Jones MD 9500 Euclid Ave. MSc. Turkelson. NY 10952 Janet L. Watters III MD 6624 Fannin #2600 Houston. MA Robert G Marx. of Family Medicine and Rural Health Florida State University. ATC Associate Professor and Director of Clinical Research. MLS 2007 -2008 Graduate Intern Michelle Scott.D.APPENDIX I WORKGROUP Conflict of Interest information for workgroup members is available in Appendix XI John Richmond MD. A41 Cleveland. PhD New England Baptist Hospital 125 Parker Hill Avenue Boston. Dept of Orthopaedic Surgery University of Pittsburgh School of Medicine Kaufmann Medical Building. WA 98105 James Irrgang PT. MBA Medical Director 6300 N River Road Rosemont. Wies MPH Clinical Practice Guidelines Manager 6300 N River Road Rosemont. MD. Suite 911 3471 Fifth Ave. OH 44195 Lynn Snyder-Mackler PT. Chair New England Baptist Hospital 125 Parker Hill Avenue Boston. MA 02120 Guidelines and Technology Oversight Vice-Chair: Michael J. Florida 32306-4300 Charles M. ATC. PA 15213 Evidence Based Practice Committee Chair: Michael Keith. Haralson III. Goldberg. MN 55905 210 . PhD Director of Research and Scientific Affairs 6300 N River Road Rosemont. NY 10021 Bruce A Levy. Call Street Tallahassee. Andre MS Medical Librarian Richard McGowan. MD Hospital for Special Surgery 535 E 70th St New York. TX 77030 David Hunter MBBS. OH 44109-1900 Morgan H. Suite 3200 1115 W. Pittsburgh. IL 60018 Elizabeth G. MD 2500 Metro Health Drive Cleveland. ScD Department of Physical Therapy University of Delaware 309 McKinly Lab Newark. MD Mayo Clinic 200 First St SW Rochester. MA 02111 Research Analysts Sara Anderson MPH Kevin Boyer Patrick Sluka MPH Justin St. MA 02120 Guidelines and Technology Oversight Chair: William C. SCS. Ph. Matzkin. IL 60018 Cheryl Rubin. MD Tufts – New England Medical Center Department of Orthopaedics 750 Washington Street Boston. DE 19716 AAOS Staff: Robert H.

technology assessment. Occupational Health and Workers’ Compensation. and translational research possible to ensure the future care for patients with musculoskeletal disorders.APPENDIX II AAOS BODIES THAT APPROVED THIS CLINICAL PRACTICE GUIDELINE Guidelines and Technology Oversight Committee The AAOS Guidelines and Technology Oversight Committee (GTOC) consists of sixteen AAOS members. Guidelines and Technology Oversight. Evidence Based Practice Committee The AAOS Evidence Based Practice Committee (EBPC) consists of ten AAOS members. representatives of the Diversity Advisory Board. Quality Assessment. and other related areas of importance. sets policy. Board of Directors The 17 member AAOS Board of Directors manages the affairs of the AAOS. 211 . Research Development. The Council is comprised of the chairs of the AAOS Biological Implants. and US Bone and Joint Decade committees. the Board of Councilors (BOC). the Council on Research. the Communications Cabinet. and Technology promotes the most ethically and scientifically sound basic. Also on the Council are the AAOS second vice-president. performance measures. The overall purpose of this Committee is to oversee the development of the clinical practice guidelines. the Orthopaedic Research Society (ORS). occupational health. planning and oversight for all activities related to quality improvement in orthopaedic practice. clinical. the Orthopedic Research and Education Foundation (OREF). regulatory pathways and standards development. the public. the Women's Health Issues Advisory Board. patient safety. Council on Research. Quality Assessment. Patient Safety. This Committee provides review. including. orthopaedic devices and biologics. and three members at large. health technology assessments and utilization guidelines. and Technology To enhance the mission of the AAOS. and determines and continually reassesses the Strategic Plan. The Council also serves as the primary resource to educate its members. the Board of Specialty Societies (BOS). but not limited to evidence-based guidelines. Biomedical Engineering. and public policy makers regarding evidenced-based medical practice. performance measures. Evidence Based Practice. and outcomes.

2008 Suggested Citation for referencing this document: American Academy of Orthopaedic Surgeons Clinical Practice Guideline on the Treatment of Osteoarthritis of the Knee (Non-Arthroplasty). 2008 212 . 2008 November 24. 2008 December 1. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS). 2008 November 25. 2008 December 6. 2008 November 20.DOCUMENTATION OF APPROVAL AAOS Workgroup Draft Completed Peer Review Completed Public Commentary Completed AAOS Guidelines and Technology Oversight Committee AAOS Evidence Based Practice Committee AAOS Council on Research Quality Assessment and Technology AAOS Board of Directors August 2008 October 15.

APPENDIX III STUDY ATTRITION FLOWCHARTS SYSTEMATIC REVIEWS Cochrane Database Literature Search Yielded 85 Citations MEDLINE Literature Search Yielded 193 Citations Step 1: Abstract Review Papers Retrieved (55) • • Excluded Abstract = 230 Identified from manual bibliography search = 7 Possibly Relevant (34) Step 2: Full-text Review Not Relevant (21) Relevant Systematic Reviews (23) Systematic Reviews Addressing Recommendations Supported by OARSI Recommendations or AHRQ Report (11) Step 3: Utilization Screening Systematic Reviews eligible for data extraction (15) Systematic Reviews only considering Author’s conclusion(s) (8) Step 4: Data Extraction Systematic Reviews Included using AMSTAR (7) Systematic Reviews Excluded using AMSTAR (8) 213 .

ACUPUNCTURE Literature Search Yielded 124 Citations Step 1: Abstract Review Papers Retrieved (40) • • Excluded Abstract = 96 Identified from manual bibliography search = 12 Step 2: Full-text Review Included (14) Systematic Reviews (13) Excluded (13) NEEDLE LAVAGE Literature Search Yielded 11 Citations Step 1: Abstract Review Papers Retrieved (7) • • Excluded Abstract = 9 Identified from manual bibliography search = 5 Step 2: Full-text Review Included (4) Excluded (3) 214 .

ARTHROSCOPIC LAVAGE AND/OR DEBRIDEMENT Literature Search Yielded 22 Citations Step 1: Abstract Review Papers Retrieved (13) • • Excluded Abstract = 9 Identified from manual bibliography search = 0 Step 2: Full-text Review Included (3) Excluded (10) REALIGNMENT OSTEOTOMY Literature Search Yielded 769 Citations Step 1: Abstract Review Papers Retrieved (74) • • Excluded Abstract = 695 Identified from manual bibliography search = 0 Step 2: Full-text Review Included (11) Excluded (63) 215 .

FREE-FLOATING INTERPOSITIONAL DEVICE Literature Search Yielded 14 Citations Step 1: Abstract Review Papers Retrieved (8) • • • Excluded Abstract = 10 Joint Registries = 4 Identified from manual bibliography search = 0 Step 2: Full-text Review Included (5) Excluded (3) 216 .

Data was extracted from the highlighted registries. National Joint Registries Reviewed 2007 Australian National Joint Replacement Registry Yes 2006 Yes 2005 Yes 2004 Yes 2003 NR 2002 NR 2001 NR 2000 NA 1999 NA Canadian Joint Replacement Registry NA Yes* NR NR NR NR NA NA NA Norwegian Arthroplasty Register NR NR NR NR NR NR NA NA NA Sweedish Knee Arthroplasty Register NA NA NA NR NR NR NR NR NR Finish Arthroplasty Registry NA NR NR NR NR NR NR NA NA Romanian Arthroplasty Register NA NA NA NA NA NA NA NA NA New Zealand National Joint Registry 19992005 7 yr Report NA NA NR NR NR NR NR NR NR Scottish Arthroplasty Project NR NR NR NR NR NR NA NA NA National Joint Registry for England and Wales NR = Data on UniSpacer was not reported NA = Report was not available Yes = Reported Data * Insufficient Data NA NA NA NA NA NA NA NA NA 217 .JOINT REGISTRIES The following Joint Registries were searched for data pertaining to free-floating interpositional devices.

The search for systematic reviews using PubMed included the follow search strategy.APPENDIX IV LITERATURE SEARCHES FOR SYSTEMATIC REVIEWS The search for eligible literature began with a search for applicable systematic reviews. 2008) • The Cochrane Database of Systematic Reviews (through February 22. Seven systematic reviews met all inclusion criteria. of which 48 were retrieved and evaluated. The full search strategies are displayed below: • PubMed (from 1966 through February 22. with limits of publication dates 1966 to present. English language and humans: ("knee"[MeSH Terms] OR knee[Text Word]) AND ("osteoarthritis"[MeSH Terms] OR osteoarthritis[Text Word]) AND "humans"[MeSH Terms] AND English[lang] AND systematic[sb] Our search for systematic reviews using the Cochrane Database of Systematic Reviews in Cochrane Reviews included the following search strategy: knee osteoarthritis AND (knee AND osteoarthritis) Our initial search of PubMed and the Cochrane Database yielded 278 systematic reviews. The search for systematic reviews was performed using the following databases. 2008) All literature searches were supplemented with manual screening of bibliographies in publications accepted for inclusion into the evidence base. In addition. the bibliographies of recent review articles were searched for potentially relevant citations. 218 .

mp.LITERATURE SEARCHES FOR PRIMARY STUDIES The literature searches for recommendations that were not addressed by existing systematic reviews were performed using the following databases. ACUPUNCTURE PubMed was searched using the following strategy: ("knee"[MeSH Terms] OR knee[Text Word]) AND ("osteoarthritis"[MeSH Terms] OR osteoarthritis[Text Word]) AND ("acupuncture"[MeSH Terms] OR ("acupuncture therapy"[TIAB] NOT Medline[SB]) OR "acupuncture therapy"[MeSH Terms] OR acupuncture[Text Word]) AND "humans"[MeSH Terms] AND English[lang] AND (Randomized Controlled Trial[ptyp] OR systematic[sb]) EMBASE was searched using the following strategy: (exp ACUPUNCTURE/ or acupuncture. or OSTEOARTHRITIS/) limited to human and English language articles.) AND (osteoarthritis. The full search strategies are listed below: • PubMed • EMBASE • CINAHL All literature searches were supplemented with manual screening of bibliographies in publications accepted for inclusion into the evidence base.mp. CINAHL was searched using the following strategy: (knee AND osteoarthritis AND acupuncture).) AND (exp KNEE/ or knee. 219 . In addition. the bibliographies of recent review articles were searched for potentially relevant citations.mp.mp. limited to English language clinical trials or systematic reviews.

NEEDLE LAVAGE PubMed was searched using the following strategy: (needle lavage OR dual lavage OR closed lavage OR tidal irrigation) AND ("knee"[MeSH Terms] OR knee[Text Word]) AND ("osteoarthritis"[MeSH Terms] OR osteoarthritis[Text Word] OR gonarthritis[Text Word] ) AND (randomized controlled trial[pt] OR clinical trial[pt] OR randomized controlled trials[mh] OR random allocation[mh] OR double-blind method[mh] OR single-blind method[mh] OR clinical trial[pt] OR clinical trials[mh] OR ("clinical trial"[tw]) OR ((singl*[tw] OR doubl*[tw] OR trebl*[tw] OR tripl*[tw]) AND (mask*[tw] OR blind*[tw])) OR ("latin square"[tw]) OR placebos[mh] OR placebo*[tw] OR random*[tw] OR research design[mh:noexp] OR comparative study[pt] OR evaluation studies[mh] OR follow-up studies[mh] OR prospective studies[mh] OR cross-over studies[mh] OR control*[tw] OR prospective*[tw] OR volunteer*[tw])) EMBASE was search using the following search strategy: (‘needle lavage’ OR (needle AND lavage) OR ‘closed lavage’ OR (closed AND lavage)) AND (osteoarthritis OR gonarthritis) . limited to English language CINAHL was searched using the following strategy: ((closed AND lavage) OR (needle AND lavage)) AND (osteoarthritis OR gonarthritis) ARTHROSCOPIC LAVAGE AND/OR DEBRIDEMENT PubMed was searched for randomized controlled trials treating OA of the knee with arthroscopic lavage and/or debridement: (lavage OR debridement) AND ("knee"[MeSH Terms] OR knee[Text Word]) AND ("osteoarthritis"[MeSH Terms] OR osteoarthritis[Text Word] OR gonarthritis[Text Word] ) AND ((English[lang])) AND ((Randomized Controlled Trial[ptyp])) 220 .

EMBASE and CINAHL were searched with the following strategy used for all databases: ‘unispacer’ Using key terms “unispacer” “uni-spacer” and “UniSpacer” the following joint registries were searched: Australian National Joint Replacement Registry Canadian Joint Replacement Registry Norwegian Arthroplasty Register Swedish Knee Arthroplasty Register Finish Arthroplasty Registry Romanian Arthroplasty Register New Zealand National Joint Registry 199-2005 7 yr Report Scottish Arthroplasty Project National Joint Registry for England and Wales 221 .OSTEOTOMY PubMed was searched using the following search strategy: ("osteotomy"[MeSH Terms] OR osteotomy[Text Word]) AND ("knee"[MeSH Terms] OR ("knee joint"[TIAB] NOT Medline[SB]) OR "knee joint"[MeSH Terms] OR knee[Text Word]) AND ("osteoarthritis"[MeSH Terms] OR osteoarthritis[Text Word] OR gonarthritis[Text Word]) AND English[lang] NOT "comment"[Publication Type] NOT "editorial"[Publication Type] AND (("1"[EDat]:"2008/02/22"[EDat]) AND (English[lang])) AND (("1"[EDat]:"2008/02/22"[EDat])) EMBASE was search using the following search strategy: (osteotomy and (knee and (osteoarthritis or gonarthritis))) limited to English Language CINAHL was searched using the following strategy: osteotomy AND (knee AND (osteoarthritis OR gonarthritis)) FREE-FLOATING INTERPOSITIONAL DEVICE Pubmed.

APPENDIX V LEVEL OF EVIDENCE 222 .

QUESTION 3 If a comprehensive literature search is not conducted the systematic review does not meet the quality standards for inclusion in AAOS clinical practice guidelines.APPENDIX VI RATING THE QUALITY OF SYSTEMATIC REVIEWS WITH AMSTAR MAJOR FLAWS QUESTION 1 If an a priori design is not utilized the systematic review does not meet the quality standards for inclusion in AAOS clinical practice guidelines. The systematic review must have “Yes” answers to 50% or more of the questions. QUESTION 7 If the scientific qualities of the individual studies is not assessed using a priori methods the systematic review does not meet the quality standards for inclusion in AAOS clinical practice guidelines. A question answered “can’t answer” is given a half credit in determining item 1. 223 . 3. QUESTION 10 Answer not applicable if: • question 9 is answered “not applicable” • meta-analysis has less than 7 studies • meta-analysis found heterogeneity QUALITY RATING To determine if a systematic review is applicable for use in an AAOS clinical practice guideline the AMSTAR results will be evaluated using the following system: 1. SPECIAL RULES QUESTION 9 If a meta-analysis is NOT performed then the answer should be “not applicable”. QUESTION 6 If the characteristics of the included studies are not presented in aggregated form the systematic review does not meet the quality standards for inclusion in AAOS clinical practice guidelines. 2. A question answered “not applicable” is ignored in determining item 1.

caregiver. evaluator) • funding source/conflict of interest • intention to treat analysis • duration of the study • number of subjects and follow-up percentage • experimental and control groups • a priori power analysis Patient Characteristics (for all treatment groups in a study) • patient inclusion/exclusion criteria • co-interventions (if used) and co-morbidities (if present) • measures of disease severity • adverse events Results (for all relevant outcomes in a study) • outcome measure • is the outcome measure patient-oriented? validated? objective/subjective? • duration at which outcome measure was evaluated • statistic reported (for dichotomous results) • mean value and measure and value of dispersion (continuous results) • statistical test used. value of test statistic.APPENDIX VII DATA EXTRACTION ELEMENTS The data elements below were extracted into electronic forms in Microsoft® Access. The extracted information includes: Systematic Reviews • Conclusions • Inclusion/Exclusion Criteria • Date Range for Included Articles • Study Designs included • Number of trials included in the review • Number of Patients • Types of Analyses used to evaluate the data • Outcome measures used (See Types of Outcomes) Study Characteristics (for all relevant outcomes in a study) • methods of randomization and allocation • use of blinding (patient. and p-value • verification of calculations 224 .

APPENDIX VIII FORM FOR ASSIGNING GRADE OF RECOMMENDATION (INTERVENTIONS) GUIDELINE RECOMMENDATION___________________________________ PRELIMINARY GRADE OF RECOMMENDATION:________________________________________ STEP 1: LIST BENEFITS AND HARMS Please list the benefits (as demonstrated by the systematic review) of the intervention Please list the harms (as demonstrated by the systematic review) of the intervention Please list the benefits for which the systematic review is not definitive Please list the harms for which the systematic review is not definitive STEP 2: IDENTIFY CRITICAL OUTCOMES Please circle the above outcomes that are critical for determining whether the intervention is beneficial and whether it is harmful Are data about critical outcomes lacking to such a degree that you would lower the preliminary grade of the recommendation? What is the resulting grade of recommendation? STEP 3: EVALUATE APPLICABILITY OF THE EVIDENCE Is the applicability of the evidence for any of the critical outcomes so low that substantially worse results are likely to be obtained in actual clinical practice? Please list the critical outcomes backed by evidence of doubtful applicability: Should the grade of recommendation be lowered because of low applicability? What is the resulting grade of recommendation? STEP 4: BALANCE BENEFITS AND HARMS Are there trade-offs between benefits and harms that alter the grade of recommendation obtained in STEP 3? What is the resulting grade of recommendation? 225 .

226 .STEP 5 CONSIDER STRENGTH OF EVIDENCE Does the strength of the existing evidence alter the grade of recommendation obtained in STEP 4? What is the resulting grade of recommendation: What is the resulting grade of recommendation? NOTE: Because we are not performing a formal cost analyses. you should only consider costs if their impact is substantial.

The number of permissible dissenters for several workgroup sizes is given in the table below: Number of Permissible Dissenters Workgroup Size ≤3 4-5 6-8 9 Not allowed. or 9 is statistically non-significant (as determined using the binomial distribution). If disagreements are not resolved after three voting rounds.APPENDIX IX VOTING BY THE NOMINAL GROUP TECHNIQUE Voting on guideline recommendations and performance measures will be conducted using a modification of the nominal group technique (NGT).25 Briefly each member of the guideline workgroup ranks his or her agreement with a guideline recommendation or performance measure on a scale ranging from 1 to 9 (where 1 is “extremely inappropriate” and 9 is “extremely appropriate”). a method previously used in guideline development. Consensus is obtained if the number of individuals who do not rate a measure as 7. no recommendation/measure is adopted. Because the number of workgroup members who are allowed to dissent with the recommendation depends on statistical significance. the recommendation/measure is adopted without further discussion. If the number of dissenters is not permissible. Three rounds of voting are held to attempt to resolve disagreements. Statistical significance cannot be obtained 0 1 1 or 2 The NGT is conducted by first having members vote on a given recommendation/performance measure without discussion. the number of permissible dissenters varies with the size of the workgroup. 8. there is further discussion to see whether the disagreement(s) can be resolved. 227 . If the number of dissenters is “permissible”.

Day. may we list your society as a reviewer of this guideline? Yes Yes Yes No No No Reviewer Instructions Please read and review this Draft Clinical Practice Guideline and its associated Technical Report with particular focus on your area of expertise. and accuracy of the interpretation of the evidence. Year 228 . If you need more space than is provided. Please feel free to also comment on the overall structure and content of the guideline and Technical Report. Please complete and return this form electronically to wies@aaos. Thank you in advance for your time in completing this form and giving us your feedback.org or fax the form back to Jan Wies at (847) 823-9769. Please send the completed form and comments y Month. We value your input and greatly appreciate your efforts. Your responses are confidential and will be used only to assess the validity. please specify the draft page and line numbers in your comments.APPENDIX X STRUCTURED PEER REVIEW FORM Reviewer Information: Name of Reviewer_________________________________________ Address_________________________________________________ City___________________ State_________________ Zip Code___________ Phone _____________________Fax ________________________ E-mail_______________________ Specialty Area/Discipline: _______________________________________ Work setting: _________________________________________________ Credentials: _________________________________________________ May we list you as a Peer Reviewer in the final Guidelines? Are you reviewing this guideline as a representative of a professional society? If yes. clarity. please attach additional pages. If applicable.

229 .

230 . If applicable.COMMENTS Please provide a brief explanation of both your positive and negative answers in the preceding section. please specify the draft page and line numbers in your comments. Please feel free to also comment on the overall structure and content of the guideline and Technical Report OVERALL ASSESSMENT Would you recommend these guidelines for use in practice? (check one) Strongly recommend Recommend (with provisions or alterations) Would not recommend Unsure _______ _______ _______ _______ COMMENTS: Please provide the reason(s) for your recommendation.

Elizabeth G Matzkin. James J Irrgang. David Hunter. PhD: 1 (President. Smith & Nephew). 1=Board member/owner/officer/committee appointments. 7 (Biomet. Apopharma). Cheryl Rubin. 5A (Mitek. MD: (n). ARS Arthro AG. MD: (n). Smith & Nephew). MD: 1 (Arthroscopy Association of North America. Arthrosurface. 7= Research or institutional support from a company or supplier. 6= Research or institutional support from a publisher. MD: 7 (DePuy. Daniel Van Durme. Merck. Orthopaedic Section of the American Physical Therapy Association). 5B= Unpaid consultant. Robert G Marx. MD: 2 (Annals of Family Medicine). 5B (Omeros). Conflicts of interest are disclosed in writing with the American Academy of Orthopaedic Surgeons via a private on-line reporting database and also verbally at the recommendation approval meeting. Morgan H Jones. 4= Speakers bureau/paid presentations. Small Bone Innovations. MD: 7 (Biomimetic. 3= Royalties. Ramapo Valley Surgical Center). 8= Stock or Stock Options. 7 (DJ Orthopaedics. 2 (Arthritis Care and Research). Serica). Lifenet. Stryker. 231 . 9= Other financial/material support from a publisher.5A= Paid consultant. Stryker. Eastern Orthopedic Association. Michael Warren Keith. 7 (Arthrex. TissueLink. Disclosure Items: (n) = Respondent answered 'No' to all items indicating no conflicts. National Institutes of Health. MD PhD: 2 (Osteoarthritis and Cartilage. DePuy. Regen Biologics. 2= Medical/Orthopaedic Publications. Pfizer. AstraZeneca). Lynn Snyder-Mackler: (n). 2 (Arthroscopy). Bruce A Levy. Eli Lilly. 10= Other financial/material support from a company or supplier. A Johnson & Johnson Company. Arthritis and Rheumatism). Wyeth. MD: 1 (Arthroscopy Association of North America. Inc. New England Baptist Hospital).APPENDIX XI CONFLICT OF INTEREST All members of the AAOS workgroup disclosed any conflicts of interest prior to the development of the recommendations for this guideline. King Pharmacy. A Johnson & Johnson Company). Diapedia LLC. Stryker. John C Richmond. MD: (n).

232 . Intrisic Therapeutics. MD: 1 (Bone and Joint Decade. Work Loss Data Institute.William Charles Watters III. 5A (Blackstone Medical. Intrinsic Therapeutics. 8 (Intrinsic Therapeutics).. 2 (The Spine Journal). Stryker. Medtronic Sofamor Danek.S. American Board of Spine Surgery). U. North American Spine Society.A. MeKessen Health Care Solutions).

Included Studies Evidence Table 21. Systematic Review 233 . Primary Studies Included in Systematic Reviews Evidence Table 19. Design and Quality Evidence Table 24. AAOS Analysis . Analysis of Laupattarakasem et al. Analysis of Systematic Reviews Needle Lavage Evidence Table 20.Excluded Studies Evidence Table 17. Characteristics of Included Systematic Reviews Evidence Table 2. Systematic Reviews Excluded using AMSTAR Evidence Table 4. Primary Studies Included in Warden et al Systematic Review Evidence Table 9. Analysis of Warden et al Systematic Review Lateral Heel Wedges Evidence Table 10. Patient Characteristics Arthroscopic Debridement Evidence Table 25. Excluded Studies Evidence Table 22. Systematic Evidence Table 26. Primary Studies Included in Brouwer et al. Analysis of Roddy et al Systematic Review Patellar Taping Evidence Table 8. Relevant Systematic Reviews Quadriceps Strengthening Evidence Table 6.APPENDIX XII EVIDENCE TABLES See Evidence Tables Document (Evidence Tables. Results Evidence Table 23. Systematic Review Knee Braces Evidence Table 12. Systematic Review Evidence Table 7. Acupuncture Evidence Table 15. Systematic Review Evidence Table 14. AMSTAR Results Evidence Table 5.pdf) Systematic Reviews Overview Evidence Table 1. Analysis of Brouwer et al. Primary Studies Included in Brouwer et al Systematic Review Evidence Table 11. Systematic Reviews Included using AMSTAR Evidence Table 3. Primary Studies Included in Roddy et al.Results Intra-articular Corticosteroids Evidence Table 18.Included Studies Evidence Table 16. AAOS Analysis of Kirkley et al. AAOS Analysis . AAOS Analysis . Analysis of Brouwer et al. Systematic Review Evidence Table 13. Primary Studies Included in Laupattarakasem et al.

Design and Quality Evidence Table 31. Results 234 . AAOS Analysis . Included Studies Evidence Table 37. Included Studies Evidence Table 33. Results Evidence Table 35.Arthroscopic Lavage (AAOS Analysis) Evidence Table 27.Results Evidence Table 30.Included Studies Evidence Table 28.Excluded Studies Evidence Table 29. AAOS Analysis . AAOS Analysis . Excluded Studies Evidence Table 34.Patient Characteristics Realignment Osteotomy Evidence Table 32. Excluded Studies Evidence Table 38. AAOS Analysis . AAOS Analysis . Complications Free-Floating Interpositional Device Evidence Table 36.

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