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Study was closed mainly because the surgeons participating no longer had the infrastructure to support the research and weren't following their subjects
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This is a multi-centre, prospective post marketing surveillance study to assess mid-term performance of the Mpact cup in subjects requiring primary total hip arthroplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mpact Acetabular Shell | Monitor the performance of the Mpact cup in the treatment of patients with hip joint disease requiring a total hip replacement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mpact Acetabular Shell | Device | Total Hip Replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Kaplan-Meier analysis as a measure of implant performance. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| The Harris Hip Score. | pre-op, 3/6 months, 1,2 and 5 years | |
| Radiological analysis as a meausure of safety. | 3/6 months, 1,2 and 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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primary total hip arthroplasty
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vail Orthopedics, P.C. | Denver | Colorado | 80230 | United States | ||
| Saint Alphonsus Regional Medical Center |
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| Boise |
| Idaho |
| 83702 |
| United States |
| Illinois Bone & Joint Institute, LLC | Libertyville | Illinois | 60048 | United States |
| Jordan Valley Medical Center | West Jordan | Utah | 84088 | United States |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D010020 | Osteonecrosis |
| D006618 | Hip Dislocation, Congenital |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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