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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
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The objective of the study is to investigate head penetration, cup migration, and clinical outcome in total hip replacements using a factorial design. Treatment groups are E-Poly versus ArComXL liners, and 36 mm versus 32 mm head size.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Poly/32 mm | Active Comparator | E-Poly polyethylene liner in a titanium cup with a stem with 32 mm cobalt-chromium (CoCr) femoral head. |
|
| E-Poly/36 mm | Active Comparator | E-Poly polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. |
|
| ArComXL/32 mm | Active Comparator | ArComXL polyethylene liner in a titanium cup with a stem with 32 mm CoCr femoral head. |
|
| ArComXL/36 mm | Active Comparator | ArComXL polyethylene liner in a titanium cup with a stem with 36 mm CoCr femoral head. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E-Poly liner | Device | E-Poly liner with a titanium cup |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean head penetration from baseline to 5 year follow-up | Mean head penetration assessed using röntgen steregrammetry analysis (RSA) from baseline to 5 year follow-up | From baseline to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Mean cup migration form baseline to 5 year follow-up | Mean cup migration assessed using RSA from baseline to 5 year follow-up | From baseline to 5 years |
| Mean change in clinical outcome score from baseline to 5 year follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Abdalla N. El-Sahoury, BSc.med | OUH Den Ortopædkirurgiske Forskningsenhed | Principal Investigator |
| Ming Ding, Professor MD | Odense University Hospital, University of Southern Denmark | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joseph Abdalla Nommesen El-Sahoury | Odense C | Region Syddanmark | 5000 | Denmark |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 19, 2018 | Jun 1, 2018 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D010003 | Osteoarthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
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| ArComXL liner |
| Device |
ArComXL liner with a titanium cup |
|
| 32 mm femoral head | Device | Stem with a 32 mm CoCr femoral head |
|
| 36 mm femoral head | Device | Stem with a 36 mm CoCr femoral head |
|
Mean change in patient-reported hip function (Harris Hip Score), quality of life (EQ-5D and SF-36), and patient activity (UCLA Activity Score).
| From baseline to 5 years |