Study Comparing Traditional and Gender-specific Total Knee Replacement Designs

Study Overview
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Brief Summary
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The purpose of this study is to compare results obtained with gender-specific and traditional knee replacement systems design among women undergoing total knee replacement surgery. Women who qualify and agree to participate will be randomly assigned to receive either a traditional or gender-specific knee replacement. During surgery, measurements of bone resection and bone-to-implant relationships will be recorded. At selected time intervals, participants will be asked to fill out questionnaires regarding pain and function, will be examined by their surgeon and routinely obtained xrays will be evaluated. In addition, a subset of participants will be randomly selected to undergo gait analysis to evaluate knee motion and muscle function.

Official Title
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A Prospective, Randomized, Control Trial Comparing Total Knee Arthroplasty With Traditional and Gender-Specific Designs

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)
* Device: Zimmer High Flex LPS Implant (Total knee replacement)
* Device: Stryker Triathlon Implant (Total knee replacement)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical diagnosis of end-stage degenerative joint disease of the knee must be deemed appropriate for total knee replacement surgery Exclusion Criteria: severe flexion deformity of the knee greater than 20deg varus or valgus malalignment osteomyelitis, septicemia, prior infection of the knee joint presence of infections or highly communicable diseases significant neurological or musculoskeletal disorders that affect gait or ability to bear weight on lower extremity metastatic disease congenital, developmental, bone disease or previous knee surgery that may interfere with the total knee prosthesis survival or success previous total knee replacement in affected knee arthrodesis of the affected knee

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gender Specific LPS flex<br>Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design | Device: Zimmer LPS flex Gender Specific Implant (Total knee replacement)<br>* Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company<br>|
| Active Comparator: LPS flex<br>Participants in this arm will receive the Zimmer High Flex LPS implant | Device: Zimmer High Flex LPS Implant (Total knee replacement)<br>* Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company<br>|
| Active Comparator: Triathlon<br>Participants in this arm will receive the Stryker Triathlon Implant design | Device: Stryker Triathlon Implant (Total knee replacement)<br>* Outcomes comparison between a gender specific total knee implant, a standard total knee implant by the same company, and a standard total knee implant from another company<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of improved pain relief and function |  | Pre-op, 4 weeks, 4 months, 1 year, 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of improved patellofemoral biomechanics |  | Pre-op, 4 months, 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Knee Replacement, Gender Specific Design