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This prospective study will evaluate the hip function and quality of life of patients operated for total hip arthroplasty with Masterloc femoral stem and MPACT acetabular cup. The results of this study will establish the performance of Masterloc femoral component (Medacta International SA) and MPACT acetabular component (Medacta International SA), and provide a general estimate of survivorship, clinical effectiveness and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup | All patients enrolled will receive the Medacta Masterloc Stem and MPACT cup with Highcross PE liner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Femoral Component:Medacta Masterloc Stem and Medacta MPACT cup. | Device | Total hip arthroplasty (THA) is one of the most commonly performed and successful orthopaedic operations in improving a patient's quality of life. Orthopaedic surgeons are continually striving to improve all aspects of care relating to this procedure whether this is improvements in implant technology, instrument improvement, or the technique involved in performing the procedure.The results of this study will establish the performance of the femoral component and acetabular component, and provide a general estimate of survivorship, clinical effectiveness and complications. |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | Assessment of the improvement of clinical outcomes following total hip replacement using the Harris Hip Score | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. |
| Hip Disability and Osteoarthritis Outcome Score (HOOS) | Assessment of the improvement in activity levels following total hip replacement using the Hip Disability and Osteoarthritis Outcome Score | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. |
| Oxford Hip Score (OHS) | Assessment of the improvement in the patients physical level of activity using the Oxford Hip Score | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. |
| Veterans Rand 12 (VR-12) | Assessment of the improvement in your health using the Veterans Rand 12 | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. |
| EuroQol 5 dimension (EQ-5D) | Assessment of the improvement in quality of life and joint movement using the EQ-5D | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic analysis | Radiographic analysis will include evaluation of osteolysis, radiolucent lines, bone hypertrophy, component migration, heterotopic ossification, resorption of calcar. | pre-operative, 4-8 weeks post-operative, 4-8 months post-operative, 9-15 months post operative, 18-30 months post-operative, 4-6 years post-operative, 9-11 years post-operative. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing surgery as part of routine care.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Othropedic Institute | Oro Valley | Arizona | 85755 | United States | ||
| Jordan Valley Medical Center of Orthopedics Rehabilitation and Excellence |
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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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|
| West Jordan |
| Utah |
| 84088 |
| United States |
| Spokane Joint Replacement Center | Spokane | Washington | 99218 | United States |
| D012216 |
| Rheumatic Diseases |