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Surgical Technique-OrthoGlide Medial Knee-Rev L

Surgical Technique-OrthoGlide Medial Knee-Rev L

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Published by: Praful Rana on Aug 22, 2012
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MS 4027 – Surgical Technique – OrthoGlide
Medial Knee ImplantRevision: L
DCO 2011-013
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 thanminimal degeneration (grade I-II chondromalacia, no loss of joint space) in the lateral and patellofemoralcompartment 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 (LBL032) 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 ABSinstruments needed to prepare the knee joint for implantation. The instruments consist of: a Tibial Shaper, FemoralCongruency Rasps, a Posterior Tissue Elevator, Posterior Tibial Rasp, Gap Gauges, Tibial Spine Gauge, TrialSelector, Trial Devices, Implant Inserter, Inserter Extension, Inserter Sleeve, and Extraction Device. The procedureis performed after arthroscopically inspecting the entire joint to assure the preoperative indications are verified. Themedial knee compartment is prepared for the implant by: releasing the posterior horn attachment of the medialmeniscus and then excising the medial meniscus to a 2 mm rim, contouring the medial tibial and medial femoralsurfaces using both arthroscopic and direct vision. This cartilage contouring process is monitored withflexion/extension gap measuring devices to achieve symmetrical flexion/extension spaces. The trial devices are thenused to size the tibial plateau and to evaluate the fit and function. Lastly, the implant is inserted and final fit isevaluated.
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 monthsPatients 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 concernabout 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 determinethe 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 themechanical 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 implantationand other bony or soft tissue abnormalities.
©2011 ABS Corporation Page 1 of 8/var/www/apps/conversion/current/tmp/scratch31792/106974645.doc
Caution:Exclude patients with Grades III or IV (Kellgren-Lawrence) osteoarthritis of the lateral orpatellofemoral 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 devicethickness will be determined intraoperatively after tibial preparation. Pre-operative size estimations may changesubsequent 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
A-P Dimension (mm)
 
 
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 theMRI 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 PlateauA-P length
OrthoGlide A-P Dimension (mm)
4.0Surgical Procedure
Ensure all instruments are available and sterilized according to the package insert (LBL-032).
Caution:Do NOT over stretch or release the medial collateral ligament (MCL) while placing valgusstress on the lower leg during surgery.Caution:Do NOT damage subchondral bone on the tibia or femur during the preparation of the joint forinsertion of the OrthoGlide Implant.
4.1Diagnostic Arthroscopy
Prepare the patient for arthroscopy in accordance with the standard practice of the orthopedic surgeon. A knee postor 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 ruleout 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 eitherthe tibia or femur in the lateral compartment.
©2011 ABS Corporation Page 2 of 8/var/www/apps/conversion/current/tmp/scratch31792/106974645.doc
Caution:Exclude patients with full thickness or near full thickness (Grade III/IV) cartilage loss on eitherthe patella or trochlear groove
4.2Arthroscopic Debridement and Posterior Meniscectomy
4.2.1 Contour Medial Aspect of Intercondylar Eminence toMatch 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 highspeed shaver, not burr). This allows a rounded right angle at the medial spineand then flattening the cartilage anterior and posterior to the spine to the levelof the tibial plateau. (Note that these areas are typically not involved in theanteromedial cartilage wear pattern and therefore will require more cartilageremoval than other areas of the tibia.)
4.2.2Medial Menisectomy – Posterior
Release the posterior horn attachment of the medial meniscus. Perform a partial menisectomy of the posterior and medial portion of the medialmeniscus to a 1 to 2 mm meniscal rim. Take special care not to violate theMCL. 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.
4.2.3Tibial Surface Contouring
Remove the necessary level of cartilage on the surface of the tibial plateau tomatch 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 flatsurface of uniform thickness onto which the implant will be seated. As with theareas anterior and posterior to the medial tibial spine, it is important to removesufficient cartilage on the posterior tibial plateau that was underneath therecently removed meniscus (where there typically is minimal cartilage thinning).
4.2.4Removal of Posterior Tibial Osteophytes
Use the Posterior Tissue Elevator to separate the posterior meniscotibial(coronary) ligament/ posterior capsule from the posterior tibia by first slippingthe 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 tocreate a space to accept the posterior lip of the implant. Once the soft tissue iselevated the Posterior Tibial Rasp can be utilized. Insert the Posterior TibialRasp and rotate the handle 90 degrees. Move the rasp in a windshield wiper motion to remove the posterior osteophytes. Start centrally and move mediallyand laterally. Attention must be paid to the PCL fossa region of the tibial plateau. Osteophytes are not uncommon in this region. In some patients, earlyosteophytes 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 Page 3 of 8/var/www/apps/conversion/current/tmp/scratch31792/106974645.doc

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