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No patients will be recruited at Massachsetts General hospital. IRB approval changed to core center.
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| Name | Class |
|---|---|
| MAKO Surgical Corp. | INDUSTRY |
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The objectives of this study are to evaluate the clinical value of robotic-assisted total hip arthroplasty with respect to acetabular cup implantation, and to document the long-term clinical outcome of patients with Total Hip Arthroplasty (THA). IRB approval will be obtained at every study site to evaluate the basic clinical outcomes and post-operative component placement accuracy of each MAKO® THA patient.
The hypothesis is that robotic preparation of the acetabulum will significantly reduce the variability and inaccuracy in the component alignment parameters that lead to post-operative complications, including implant failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase II | An evaluation of long-term outcomes, patient reported outcomes, and radiographic analysis will be conducted prospectively on 500 patients | ||
| Phase I | An analysis of post-operative component positioning will be evaluated for 500 patients, retrospectively. |
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| Measure | Description | Time Frame |
|---|---|---|
| Survivorship of Components | Defined as implant remaining in subject. | 10 Years |
| Adverse Events | Protocol deviations, complications, "lost to follow-up" | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Retrieval Analysis of implants from revision surgery | When possible, analysis of the THR components that are removed at revision surgery will be anlaysed for signs of component impingment or signs of damage related to component position. These observations will be correlated to the clinical reason for revision. | Up to 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment/questionaire HOOS | Hip Disability and Osteoarthritis Outcome | Pre-op, 1, 3, 5, 7, 10 years after surgery |
| Assessment/Questionaire UCLA Activty Score | Assesses level of activity |
Inclusion Criteria:
Exclusion Criteria:
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Adults requiring a total hip arthroplasty procedure.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Pre-op, 1, 3, 5, 7, 10 years after surgery |
| Assessment/Questionaire EQ-5D | General health and cost effective analysis | Pre-op, 1, 3, 5, 7, 10 years after surgery |
| Assessment/questionaire | Hip desease specific questionaire | Pre-op, 1, 3, 5, 7, 10 years after surgery |
| Assessment/Questionaire Case Mix Indicator | Identifies comorbidities | Pre-op, 1, 3, 5, 7, 10 years after surgery |