A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function

Study Overview
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Brief Summary
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The purpose of this study was to compare functional and radiographic results, range of motion of the knee, patient satisfaction, femoral component, revision and complication rates in patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.

Detailed Description
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Recently much debate and discussion has focused on the effect of gender-specific total knee arthroplasty. The purpose of this study was to compare functional and radiographic results, range of motion of the knee, patient satisfaction, femoral component, revision and complication rates in patients receiving either a standard posterior cruciate substituting-flex (LPS-flex) or gender-specific posterior cruciate substituting-flex (LPS-Flex) total knee prosthesis.

Official Title
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A Gender-Specific Posterior Cruciate-Substituting High-Flexion Knee Prosthesis Does Not Improve Fit and Function Compared With a Standard Posterior Cruciate-Substituting High-Flexion Knee Prostheis A Prospective, Randomized Study

Conditions
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Osteoarthritis of the Knee, Female

Intervention / Treatment
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* Device: Standard LPS flex TKA
* Device: Gender specific LPS -Flex TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: End-stage osteoarthritis of the knee joint requiring total knee arthroplasty with bilateral disease, in female patients Exclusion Criteria: Male patient Inflammatory disease patient with other Lower extremity disease which may affect functional outcome Neurologic disease effecting patients lower extremity Revision surgery
Sexes Eligible for Study
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Female

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard LPS Flex<br>Nexgen LPS-Flex total knee design used for TKA | Device: Standard LPS flex TKA<br>* TKA by Standard LPS flex TKA<br>* Other names: Standard Zimmer Nexgen Legacy posterior stabilized High-flex;|
| Experimental: Gender specific LPS-Flex<br>Gender specific LPS flex design used for TKA in female patients | Device: Gender specific LPS -Flex TKA<br>* Total knee design created specific for female patients<br>* Other names: Gender specific Zimmer LPS High-flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee function |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implant fit to patient |  | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gender specific knee, osteoarthritis, total knee arthroplasty