Comparison of High Flex and Standard Rotating Platform Total Knee Arthroplasty (TKA)

Study Overview
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Brief Summary
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The goal of this study is to determine if the rotating platform high flex design provides improved flexion compared to the standard rotating platform TKA.

Official Title
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A Prospective Comparison of Rotating Platform Cruciate Substituting Total Knee Arthroplasty With Rotating Platform High-Flex Cruciate Substituting Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Rotating Platform High-Flex Cruciate Substituting TKA
* Device: Rotating Platform Cruciate Substituting TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 40 to 75 years old Primary diagnosis of osteoarthritis of the knee Patients who, in the investigator's opinion, are appropriate candidates for a cemented, rotating platform TKA. Patients who, in the investigator's opinion, are capable of participation in a clinical trial and reliable enough to return for follow-up appointments. Exclusion Criteria: Pregnant or lactating female subjects Patients with post-traumatic or inflammatory arthritis Patients with a fixed flexion contracture of greater than 20 degrees Patients with advanced hip, spine, or ankle disease Patients with a BMI greater than 40, where knee flexion may be limited by soft tissues

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rotating Platform High-Flex Cruciate Substituting TKA<br> | Device: Rotating Platform High-Flex Cruciate Substituting TKA<br> <br> |
| Other: Rotating Platform Cruciate Substituting TKA<br> | Device: Rotating Platform Cruciate Substituting TKA<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | Preoperative, 4-6 weeks | 
| Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | 4-6 months | 
| Clinical Flexion | Maximum, passive flexion and extension of the operated knee joint in the supine position will be measured and recorded using a long goniometer. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Flexion | Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs. | preoperative, 4-6 weeks | 
| Radiographic Flexion | Lateral radiographs of the knee will be taken with the patient supine with maximal passive knee flexion. Flexion will then be measured directly from these radiographs. | 1 year | 
| Knee Society Score (KSS) | A standard clinical evaluation system for reporting results for patients undergoing total knee replacement. The minimum score is 0 and the highest score is 100. A higher score represents a better outcome. | 1 year | 
| Oxford Knee Score | A patient reported questionnaire for assessing the outcome of knee surgery. The minimum score is 0 and the maximum score is 48. A higher score represents a better outcome. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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total knee replacement, high flexion, range of motion, rotating platform, TKA