Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration

Study Overview
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Brief Summary
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There have been considerable efforts to control rising health care costs. One of the more recent developments is the practice of reprocessing single use medical devices. This practice has been shown to provide considerable savings for health care payers. Medical devices have been reprocessed in a number of different medical fields including Orthopaedic Surgery. One of the devices that has been reprocessed are the Precision Saw Blades from Stryker Inc. These saw blades are used during Total Knee Arthroplasty (TKA) surgery. The reprocessed Precision saw blades are Health Canada approved and are available at Capital Health. Beyond the benefits to the environment and cost savings, the investigators do not know if the reprocessed saw blades work better, work worse or the same as non reprocessed saw blades. This study is designed to determine if the reprocessed saw blades used during a TKA work as well as a new saw blade.

Official Title
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Effect of Cutting Blades for Total Knee Arthroplasty on Implant Migration. A Randomized Controlled Study With Radiostereometric Analysis

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: New saw blade
* Procedure: Reprocessed saw blade


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic osteoarthritis of the knee indicating surgical intervention Between the ages of 21 and 80 inclusive Ability to give informed consent Exclusion Criteria: Significant co-morbidity affecting ability to ambulate Flexion contracture greater than 15° Extension lag greater than 10° Tibial subluxation greater than 10 mm on standing AP radiograph Prior arthroplasty, patellectomy or osteotomy with the affected knee Lateral or medial collateral ligament instability (> 10° varus/valgus) Leg length discrepancy greater than 10 mm Bone quality precluding uncemented fixation Pregnancy Active or prior infection Morbid Obesity (BMI > 40) Medical condition precluding major surgery Severe osteoporosis or osteopenia Neuromuscular impairment

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: New saw blade<br>New saw blade | Procedure: New saw blade<br> <br> |
| Active Comparator: Reprocessed saw blade<br>Reprocessed saw blade | Procedure: Reprocessed saw blade<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant migration | Implant migration assessed with RSA | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economics | Cost comparison of saw blades | 1 year |