MS 4027 – Surgical Technique – OrthoGlide® Medial Knee Implant Revision: M

DCO 2012-017

1.

Intended Use
The OrthoGlide ® Medial Knee Implant is intended for use in the osteoarthritic knee, where substantial amounts of cartilage have been lost as a result of the disease. The device is indicated for uncemented use in the treatment of moderate degeneration of the medial compartment of the knee (grade II-IV chondromalacia) with no more than minimal degeneration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoral compartment in patients with osteoarthritis.

Consult the ABS Package Insert (LBL 032) for additional information.
The Instructions for Use (IFU) Surgical Technique is to be used in conjunction with the ABS Package Insert (LBL 032) in order to perform the ABS OrthoGlide procedure. Consult the ABS Package Insert for Warnings, Precautions, and Contraindications. CAUTION – Federal law (U.S.A.) restricts this device to sale by or on the order of a physician.

2.

Product Description
The ABS OrthoGlide Medial Knee Implant System consists of a sterile Co-Cr implant and associated ABS instruments needed to prepare the knee joint for implantation. The instruments consist of: a Tibial Shaper, Femoral Congruency Rasps, a Posterior Tissue Elevator, Posterior Tibial Rasp, Gap Gauges, Tibial Spine Gauge, Trial Selector, Trial Devices, Implant Inserter, Inserter Extension, Inserter Sleeve, and Extraction Device. The procedure is performed after arthroscopically inspecting the entire joint to assure the preoperative indications are verified. The medial knee compartment is prepared for the implant by: releasing the posterior horn attachment of the medial meniscus and then excising the medial meniscus to a 2 mm rim, contouring the medial tibial and medial femoral surfaces using both arthroscopic and direct vision. This cartilage contouring process is monitored with flexion/extension gap measuring devices to achieve symmetrical flexion/extension spaces. The trial devices are then used to size the tibial plateau and to evaluate the fit and function. Lastly, the implant is inserted and final fit is evaluated.

3.

Pre-Operative Planning
Patient Expectations: • May need subsequent aspirations and corticosteroid injections if effusions occur, which is not uncommon • Time to optimal pain relief may be 6 to 12 months Patients should have the following radiographs taken of the operative knee within three months prior to surgery: • Anteroposterior (AP) view – weight bearing • Knee flexed 45 degrees, PA view ( Rosenberg or Skier view) - weight bearing • Lateral view • Merchant axial patellofemoral view • Hip to ankle alignment view In addition, an MRI may be used to aid in patient selection and evaluation especially when there is concern about the status of the patellofemoral or lateral compartments. Pre-operative planning for each patient includes measurement of the tibial plateau on the lateral view to determine the approximate size (AP) of the implant with correction of the degree of radiographic magnification. The indicated patient has an anatomic angular deformity of 4 degrees varus to 2 degrees valgus or as measured using the mechanical axis, up to 10 degrees varus. Evaluate the pre-operative x-rays and MRI for eligibility criteria including: cartilage loss, joint space, ligament integrity, anatomic and or mechanical axis and osteophytes that could interfere with implantation and other bony or soft tissue abnormalities. ©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc Page 1 of 8

Caution:

Exclude patients with Grades III or IV (Kellgren-Lawrence) osteoarthritis of the lateral or patellofemoral compartments of the knee. Identify osteophytes that will be addressed in surgery especially on the Posterior Tibia, Medial Femur and Tibia, Anterior Femur and Tibial / Femoral Notch. At the time of surgery, confirm pre-operative size estimations of the anterior-posterior (A-P) dimension. The device thickness will be determined intraoperatively after tibial preparation. Pre-operative size estimations may change subsequent to direct measurement at surgery. The OrthoGlide Medial Knee Implant comes in LEFT & RIGHT knee configurations, A-P lengths of 42 to 58 mm, and thicknesses 3 mm and 4 mm (see Table 1).

Table 1 -OrthoGlide Medial Knee Implant Sizes
Thickness (mm) 3 4

A-P Dimension (mm)
42   46   50   54   58  

Table 2 shows the range of tibial A-P sizes and the proper implant size selection to match tibial plateau length. Choose patients whose pre-operative assessment indicates an A-P length of 39 to 58 mm. Use a radiographic ruler to account for magnification on x-rays (for example, 10 to 20%). Alternatively, use the scale (ruler) built into the MRI for all measurements. Assess concavity of the tibial plateau and its potential for congruency with the bottom of the implant.

Table 2 – Relationship of tibial plateau length and implant size
Tibial Plateau A-P length Minimum Maximum

OrthoGlide A-P Dimension (mm)
42 39 42 46 43 46 50 47 50 54 51 54 58 55 58

4.0

Surgical Procedure
Ensure all instruments are available and sterilized according to the package insert (LBL-032). Caution: Caution: Do NOT over stretch or release the medial collateral ligament (MCL) while placing valgus stress on the lower leg during surgery. Do NOT damage subchondral bone on the tibia or femur during the preparation of the joint for insertion of the OrthoGlide Implant.

4.1

Diagnostic Arthroscopy
Prepare the patient for arthroscopy in accordance with the standard practice of the orthopedic surgeon. A knee post or thigh holder should be used to facilitate the application of valgus stress during the procedure. Perform a standard complete diagnostic arthroscopy evaluating all three knee compartments. Inspect for and rule out moderate to advanced OA in the lateral and patellofemoral compartments. Verify integrity of the ligaments (ACL, PCL, MCL and Lateral Complex). Observe for a collapse or loss of contour of the tibial plateau. Caution: Exclude patients with full thickness or near full thickness (Grade III/IV) cartilage loss on either the tibia or femur in the lateral compartment.

©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc

Page 2 of 8

Caution:

Exclude patients with full thickness or near full thickness (Grade III/IV) cartilage loss on either the patella or trochlear groove

4.2

Arthroscopic Debridement and Posterior Meniscectomy
4.2.1 Contour Medial Aspect of Intercondylar Eminence to Match Lateral Aspect of OrthoGlide

Remove the cartilage on the medial aspect of the intercondylar eminence (ICE) on the tibial spine area down to subchondral bone (typically with a high speed shaver, not burr). This allows a rounded right angle at the medial spine and then flattening the cartilage anterior and posterior to the spine to the level of the tibial plateau. (Note that these areas are typically not involved in the anteromedial cartilage wear pattern and therefore will require more cartilage removal than other areas of the tibia.)

4.2.2

Medial Menisectomy – Posterior

Release the posterior horn attachment of the medial meniscus. Perform a partial menisectomy of the posterior and medial portion of the medial meniscus to a 1 to 2 mm meniscal rim. Take special care not to violate the MCL. The anterior ½ of the meniscus is typically removed during the open portion of the procedure. In the posterior region that will accept the posterior OrthoGlide lip, the meniscal tibial attachment is elevated. Avoid injury to the posterior capsule.

4.2.3

Tibial Surface Contouring

Remove the necessary level of cartilage on the surface of the tibial plateau to match the point of maximal wear. If the maximal wear is to bone, then the entire plateau will be smoothed to the calcified cartilage level. The goal is a flat surface of uniform thickness onto which the implant will be seated. As with the areas anterior and posterior to the medial tibial spine, it is important to remove sufficient cartilage on the posterior tibial plateau that was underneath the recently removed meniscus (where there typically is minimal cartilage thinning).

4.2.4

Removal of Posterior Tibial Osteophytes

Use the Posterior Tissue Elevator to separate the posterior meniscotibial (coronary) ligament/ posterior capsule from the posterior tibia by first slipping the distal portion of the Posterior Tissue Elevator over the rim of the posterior tibia and rotating it 90 degrees. The purpose of this soft tissue elevation is to create a space to accept the posterior lip of the implant. Once the soft tissue is elevated the Posterior Tibial Rasp can be utilized. Insert the Posterior Tibial Rasp and rotate the handle 90 degrees. Move the rasp in a windshield wiper motion to remove the posterior osteophytes. Start centrally and move medially and laterally. Attention must be paid to the PCL fossa region of the tibial plateau. Osteophytes are not uncommon in this region. In some patients, early osteophytes may not be visible on radiographs, but would still interfere with posterior OrthoGlide lip insertion and thus need to be identified and removed. Care must be taken not to disrupt the anatomy of the posterior medial tibial plateau.

©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc

Page 3 of 8

4.3

Arthrotomy and Fat Pad Removal
Create a mini-arthrotomy by extending the medial arthroscopic portal vertically 1.5-2 inches (5-7 cm). Remove a portion of the infrapatellar fat pad for improved visualization.

4.4

Medial Menisectomy
Complete the menisectomy of the anterior portion of the medial meniscus. Care must be taken not to disturb the MCL.

4.5

Osteophyte Removal
Remove all osteophytes from the anterior, posterior and medial rim of the tibial plateau and femoral condyle and then smooth with a manual or power rasp. Removal of these “MCL tenting” osteophytes will allow a greater opening of the medial joint space. Anterior osteophytes or hypertrophy and sclerosis of the anterior tibial rim (highlighted area) can cause the OrthoGlide implant to sit too high anteriorly and cause impingement or overstuffing against the anterior medial femoral condyle on extension. A hand rasp may be used to remove 1-2 mm on the anterior superior rim of the tibia if this area is too prominent.

4.6

Tibial Plateau Surface Preparation
Use the ABS Tibial Shaper in a compatible reciprocating instrument to remove the cartilage to a uniform level throughout, typically near the calcified cartilage level. Use the Tibial Shaper in 10 second intervals, assessing the progress of contouring between each use to be sure subchondral bone is not violated.

©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc

Page 4 of 8

4.7

Flexion and Measurement

Extension

Gap

Balanced extension and flexion gaps are important for natural ligament tension through range of motion. With the OrthoGlide, the goal is to have balanced flexion and extension gaps. At this point in the procedure, the tibial cartilage resection is set and the “patient’s arthritis has set the extension gap. The ABS Gap Gauges (3mm, 4mm) are used to measure the extension gap and select the Trial Device thickness most appropriate for the patient. The Gap Gauges should be used with the knee in the neutral position and the gauge should slip in without forcing it in both the extended and flexed positions. With medial compartment arthritis more posterior femoral condyle cartilage remains intact. Therefore, the flexion gap at this point is smaller than the extension gap.

4.8

Tibial Plateau Sizing
Use the Trial Selector to estimate the correct trial size. Hook the probe over the posterior rim along the centerline of the medial tibial plateau and slide the tube so that it aligns with the anterior margin of the medial tibial plateau. Select the trial device that is close to the number at the end of the tube. As an alternative, use an arthroscopic probe or the posterior tibial rasp to estimate the correct trial size. Hook the probe or rasp over the posterior rim along the centerline of the medial tibial plateau and attach a clamp that aligns with the anterior margin of the medial tibial plateau. Measure this length with a ruler to estimate the Trial Device and Femoral Congruency Rasp anteroposterior (AP) length. Place the appropriate AP length 3 mm thick Trial Device on the tibial plateau with the posterior lip towards the medial tibial plateau. Use external rotation and valgus stress on the lower leg, and then move to ~30° of flexion while exerting posteriorly directed horizontal force on the Trial Device to accomplish insertion. Confirm the trial is fully inserted over the posterior tibial rim and that it is the appropriate length for the tibial plateau by visualization with respect to the anterior edge of the tibial plateau. The trial should cover the entire prepared medial tibial joint surface and the anterior edge of the trial should be at least even with or slightly longer than the tibial plateau. This can be further confirmed by feeling the superior/anterior portion of the trial while the leg is in full extension. A C-arm can also be utilized to assess proper trial device sizing.

4.9

Smoothing the Femoral Condyle while Balancing the Flexion and Extension Gap
After the initial assessment of the implant size using the Trial Device, insert either a Femoral Smoother or Femoral Congruency Rasp (the same size as the trial device) using the same procedure as the trial device. With the Femoral Smoother or Femoral Congruency Rasp in place on the tibia, fully flex and extend the knee while placing varus stress on the lower leg. When performing ROM cycles, check for uniform smoothing of the femoral condyle and smoothness of ROM in the joint. Inspect the joint frequently and clear the rasp of cartilage debris. The goal is a smooth transition of cartilage with emphasis on removing posterior condyle cartilage by using increased varus pressure as the knee is moved through deep flexion until the Gap Gauge smoothly inserts with the same force in flexion as previously determined in extension. When complete, thoroughly irrigate the joint to remove any cartilaginous debris. The flexion and extension spaces should now be equal.

©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc

Page 5 of 8

4.10 Tibial Spine Spacing
Now take the Tibial Spine Gauge and place it in the prepared area along the intercondylar eminence at full extension and at deep flexion to assess the space available for the mesial ridge of the implant. This will help prevent any impingement of the implant on the lateral aspect of the medial femoral condyle. With the gauge in place move the knee through a full range of motion and look for impingement on the medial femoral condyle. If impingement is found, a more extensive preparation of the intercondylar eminence and/or the medial femoral condyle will be needed.

4.11 Trial Device Insertion and Final Size Evaluation
Choose a Trial Device based on Femoral Congruency Rasp size and the Gap Gauge thickness. Insert the trial device in the same manner as before. Assess the Trial Device fit by: 1. The Trial Device covers the entire prepared medial tibial joint surface so that the anterior edge of the Trial is at least even with or slightly longer than the tibial plateau. This can be assessed by visualizing the superior/anterior portion of the Trial Device while the leg is in full extension. A Carm can also be utilized to assess proper Trial Device sizing. 2. The posterior lip of the Trial Device is engaged over the edge of the tibial plateau, and firmly resists anterior movement when traction is applied to the handle. A C-arm is used to optimize assessment. 3. The knee is cycled through full ROM (flexionextension). Note that there should be no or minimal movement of the front edge of the Trial Device. 4. The surface of the medial femoral condyle is in contact and shows good congruency with the Trial Device gliding path and there is no impingement occurring between the front margin of the femur and the anterior portion of the trial implant or between the central ridge of the implant and both the central margin of the femoral condyle and the prepared vertical wall of the medial spine/ intercondylar eminence during full range of motion.

©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc

Page 6 of 8

4.12 OrthoGlide Implantation
Choose the appropriate ABS OrthoGlide Implant based upon the Trial Device evaluation. With the Inserter Sleeve on the upper jaw of the Inserter, grasp the anterior portion of the implant (end away from lip) firmly in the jaws of the Inserter and tighten the knob hand-tight. Hold the posterior edge of the device firmly against the joint space. Place the knee in 20-45° of flexion with external rotation of the tibia and valgus stress on the knee. Controlled posterior force is necessary for insertion of the implant. As posterior force is applied, the device is rotated towards the PCL tibial attachment. Once the device posterior lip engages over the posterior aspect of the tibia, remove the Inserter by loosening the jaws. If the Inserter interferes with the joint so the implant lip will not engage, the Inserter Extension may be used to help position the implant. Making sure the implant stays in the joint, remove the Inserter from the implant. Remove the Inserter Sleeve from the Inserter. Clamp the Inserter Extension in the Inserter and tighten the knob hand-tight. Place the Inserter with Inserter Extension against the implant and apply posterior force, until the device posterior lip engages over the posterior aspect of the tibia.

4.13 OrthoGlide Evaluation
Assess the following aspects of the implant directly and using fluoroscopy (AP and lateral views): 1. The implant fit is the same as the Trial Device. 2. The knee can be cycled through full available ROM (flexion-extension) and the front edge of the implant has minimal motion. The posterior lip of the implant is engaged over the edge of the tibial plateau, and firmly resists anterior movement. The anterior edge of the implant is at least even with the anterior margin of the tibia or extends slightly beyond it. The surface of the medial femoral condyle is in contact with the implant glide path. The medial-lateral stability of the knee is acceptable.

3.

4.

5. 6.

If any of the parameters assessed above are not suitable, remove the implant. This is best accomplished by using the provided extractor. Once a firm grip has been established on the implant, firmly pull anteriorly on the implant while the knee is flexed to 30 degrees, lower leg is externally rotated, and valgus stress is applied to the knee. Determine whether further joint preparation or a different implant size---or both---is needed and repeat the implant evaluation. If the same implant is to be re-inserted, inspect the femoral articulating surface of the implant. If it was scratched during extraction, replace with a new implant.

©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc

Page 7 of 8

4.14 Completion of the procedure
At the completion of the procedure, with the appropriate implant in place, irrigate the knee joint, aspirate and close in layers. Apply a standard compressive dressing and a knee brace locked in extension or a knee immobilizer.

5.0

Recommendations for Rehabilitation of the Knee
1. 2. Use a compression dressing, cryotherapy and elevation in the immediate post-operative period. Crutches are used to allow touch-down weight bearing until the anesthetic has dissipated. Progressive weight bearing is allowed and encouraged as soon as tolerated with a normal gait—no limping. Patients are instructed to fully extend the operative knee as they walk. Crutches, a walking stick, or cane are used as necessary during this phase. Patients should ambulate frequently each day for short periods. Walking times and distances should increase as tolerated. When at rest, patients should flex and extend their operated knee and both ankles hourly. Prop the foot and ankle on a pillow to allow full knee extension and actively push the knee into maximal extension. This is supplemented with prone hangs three times per day. Patients should perform non-weight bearing active range of motion exercises for the operative knee at least 4 times a day until they achieve full range of motion. Advise patients to avoid combined bending and twisting motions of the operative knee. Advise patients not to pivot on their operative knee for the first month. With an individual patient specific approach, patients should gradually resume a low activity level that may consist of walking, swimming, recreational bicycling and light labor as tolerated. Patients should not resume full strenuous activity for 6 weeks to allow the bone to adjust to the implant. Patients with osteopenia or osteoporosis need to be instructed to avoid strenuous activity of the implanted knee. It is recommended to avoid aggressive physical therapy.

3.

4. 5. 6. 7.

8.

For further information, contact: ABS Corporation 5909 Baker Road, Suite 550 Minnetonka, MN 55345 (952) 979-0002

END OF DOCUMENT

©2011 ABS Corporation /var/www/apps/conversion/current/tmp/scratch_2/110273994.doc

Page 8 of 8

Master your semester with Scribd & The New York Times

Special offer for students: Only $4.99/month.

Master your semester with Scribd & The New York Times

Cancel anytime.