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After a review of status, request of investigators & since similar data was available from other sources
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The primary purpose of this investigation is to evaluate the surgical performance of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee and Instrumentation in a Multi-centre setting.
The secondary objective of this investigation is to evaluate the long-term survivorship of the DePuy Minimally Invasive (Preservation) Unicompartmental Knee.
Primary endpoint - to demonstrate the suitability of the developed instrumentation to safely and accurately implant the preservation Unicompartmental Knee using postoperative radiographic limb and component alignment data.
Secondary endpoints - to demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiological assessment, Oxford Knee Score and survivorship analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preservation Unicompartmental Knee | Other | Minimally invasive orthopaedic implant for single compartment knee arthritis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preservation Unicompartmental Knee | Device | Minimally invasive orthopaedic implant for single compartment knee arthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the suitability of the developed instrumentation to safely and accurately implant the Preservation Unicompartmental Knee using radiographic and intra-operative assessment | Intraoperative | 0 days |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the survivorship and performance of the Preservation Unicompartmental Knee using the American Knee Society clinical and radiographic assessment, Oxford Knee Score and survivorship analysis. | 6 months, 1, 3, 5, 10 and 15 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Dwyer, Ph.D | DePuy Synthes Joint Reconstruction | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sportsmed SA, 32 Payneham, Stepney | Adelaide | South Australia | 5069 | Australia |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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