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| Name | Class |
|---|---|
| Zimmer Biomet | INDUSTRY |
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There are two distinct aims of this study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Total hip Arthroplasty E-Poly™ liner in a titanium plasma sprayed RingLoc® shell |
|
| 2 | Active Comparator | Total hip Arthroplasty ArcomXL® polyethylene liner in a titanium plasma sprayed RingLoc® shell |
|
| 3 | Active Comparator | Total hip Arthroplasty E-Polyâ„¢ liner with Regenerex Ringloc +â„¢ shell |
|
| 4 | Active Comparator | Total hip Arthroplasty ArcomXL® polyethylene liner with Regenerex Ringloc +™ shell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Total Hip Arthroplasty | Procedure | Surgical implantation of specific hip replacement components for treatment of osteoarthritis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship: length of time implant remains without revision | Evaluated at 1,3,5,7 ,10th year over 10 years | |
| Complications and Adverse Events | Evaluated at 1,3,5,7 ,10th year over 10 years | |
| Incidence of radiolucencies (acetabular component) | Evaluated at 1,3,5,7 ,10th year over 10 years | |
| Patient administered Outcome Survey scores | Evaluated at 1,3,5,7 ,10th year over 10 years | |
| Polyethylene wear rates from AP radiographs | Evaluated at 1,3,5,7 ,10th year over 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survivorship in subcategories of infection, aseptic loosening and other | 1,3,5,7,10 yr over 10 years | |
| Subcategories of the outcome scores regarding pain, patient satisfaction, function,general quality of life. | 1,3,5,7,10 yr over 10 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henrik Malchau, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26692248 | Derived | Sillesen NH, Greene ME, Nebergall AK, Huddleston JI, Emerson R, Gebuhr P, Troelsen A, Malchau H. 3-year follow-up of a long-term registry-based multicentre study on vitamin E diffused polyethylene in total hip replacement. Hip Int. 2016 Jan-Feb;26(1):97-103. doi: 10.5301/hipint.5000297. Epub 2015 Dec 11. |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019644 | Arthroplasty, Replacement, Hip |
| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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| Other outcomes that may be relevant. | 1,3,5,7,10 yr over 10 years |
| Retrieval analysis | 1,3,5,7,10 yr over 10 years |
| D012216 |
| Rheumatic Diseases |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |