Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

Study Overview
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Brief Summary
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Patients were randomly assigned to a fixed bearing or rotating platform of two prostheses. A subsequent study (the one retrospectively registering the original study) asked these patients a series of questions from published questionnaires to assess long term outcomes.

Official Title
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Outcomes of Rotating Platform Versus Mobile Bearing Total Knee Arthroplasty

Conditions
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Total Knee Arthroplasty

Intervention / Treatment
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* Device: Fixed bearing total knee arthroplasty
* Device: Rotating platform total knee arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Osteoarthritis Rheumatoid or other inflammatory arthritis Post-traumatic arthritis Juvenile rheumatoid arthritis Avascular necrosis Exclusion Criteria: History of recent/active joint sepsis Charcot neuropathy Psycho-social disorders that would limit rehabilitation Metabolic disorders of calcified tissues, such as Paget's disease Joint replacement due to autoimmune disorders Skeletal immaturity Ligamentous laxity requiring a constrained prosthesis
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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rotating platform total knee arthroplasty<br>These patients were randomly assigned to receive a rotating platform total knee arthroplasty. | Device: Rotating platform total knee arthroplasty<br>* Rotating platform total knee arthroplasty<br>|
| Active Comparator: Fixed bearing total knee arthroplasty<br>These patients were randomly assigned to receive a fixed bearing total knee arthroplasty. | Device: Fixed bearing total knee arthroplasty<br>* Fixed bearing total knee arthroplasty<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Status over time | Knee Society Clinical Rating Scale | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. | 
| Change in Osteoarthritis Status over time | Western Ontario and McMaster University Osteoarthritis Index (WOMAC)- A 24 item questionnaire to assess pain, stiffness, and physical function in patients with hip or knee osteoarthritis divided into 3 subscales: Pain (5 items), Stiffness (2 items), Physical function (17 items) | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. | 
| Change in Overall Health Status over time | Medical Outcomes Study Short Form -36 Health Survey (SF-36)- A 36 item questionnaire to assess overall health. | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Satisfaction of Knee over time | 4-point Likert scale used to assess satisfaction with knee Scale-1. Extremely satisfied 2. Satisfied 3. Unsatisfied 4. Extremely unsatisfied | Pre-operative, Post-operative Week 6, Month 3, Month 6, Year 1, Year 2, Year 5, Year 10, Year 12, Year 15 and Year 20. |