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| ID | Type | Description | Link |
|---|---|---|---|
| RMM001 |
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| Name | Class |
|---|---|
| Stryker Orthopaedics | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gender Specific LPS flex | Experimental | Participants in this arm will receive the Zimmer LPS flex Gender Specific Implant design |
|
| LPS flex | Active Comparator | Participants in this arm will receive the Zimmer High Flex LPS implant |
|
| Triathlon | Active Comparator | Participants in this arm will receive the Stryker Triathlon Implant design |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer LPS flex Gender Specific Implant (Total knee replacement) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of improved pain relief and function | Pre-op, 4 weeks, 4 months, 1 year, 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Evidence of improved patellofemoral biomechanics | Pre-op, 4 months, 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| R. Michael Meneghini, M.D. | University of Connecticut Health Center, Farmington CT, United States | Principal Investigator |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019645 | Arthroplasty, Replacement, Knee |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Zimmer High Flex LPS Implant (Total knee replacement) | Device | 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 |
|
| Stryker Triathlon Implant (Total knee replacement) | Device | 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 |
|
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |