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| Name | Class |
|---|---|
| Smith & Nephew, Inc. | INDUSTRY |
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Retro/Prospective study to collect 2 year follow-up on REDAPT sleeved stem.
The purpose of this study is to assess performance and safety of the Smith & Nephew REDAPT Sleeved Stem by collecting retrospective 2 year post-op with PROMs or prospective 2 year post-op with PROMs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Other | subjects who have redapt sleeved stem implant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REDAPT Sleeved Stem | Device | The REDAPT Sleeved Stem is designed to provide secondary proximal support to the distal fixation and enhance implant stability. |
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| Measure | Description | Time Frame |
|---|---|---|
| Harris HIp Score (HHS) | measures pain, function, absence of deformity and range of motion after hip surgery. This is performed by a qualified health care provider. The higher the score, the better the outcome. | 2 years |
| Hip Disablity and Osterarthritis Outcome Score (HOOS) | Scoring from 0-100 with 0 indicating the worst possible hip symptoms and 100 indicating no symptoms. This tool assesses patients opinion of their hip and associated problems, evaluate symptoms and functional limitations. There are 40 items assessing 5 subscales of: Pain, symptoms, activities of daily living (ADL), function in sport and recreation and Hip related quality of life. | 2 year |
| HOOS Jr. | Scoring from 0-100 with 0 indicating the worst possible hip symptoms and 100 indicating no symptoms. This tool assesses patients opinion of their hip and associated problems, evaluate symptoms and functional limitations. this version is shortened to 6 questions assessing function, pain and quality of life. | 2 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foundation for Orthopaedic Research and Education | Tampa | Florida | 33607 | United States |
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Participants who have been implanted with REDAPT Sleeved Stem
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