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The primary objective of this study is to investigate the accuracy of the femoral implant placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing (BHR) surgery postoperatively after total hip resurfacing using the BHR System.
This is a prospective, multi- site, clinical study of clinical outcomes following hip resurfacing using VISIONAIRE Femoral Alignment Guide. The objective of this study is to evaluate the safety and efficacy of the blocks and to assess alignment of the BHR system when using VISIONAIRE Femoral Alignment Guide. This study will also document any device-related surgical complications or adverse radiographic observations.
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| Measure | Description | Time Frame |
|---|---|---|
| Investigate the accuracy of the femoral implant placement utilizing the VISIONAIRE Femoral Alignment Guide in BHR surgery postoperatively after total hip resurfacing using the BHR System | Radiographic evaluation of postoperative femoral stem angle. | 6 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Surgical and device related adverse events or revision | 6 week and 6 month |
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Inclusion Criteria:
Males or females, at least 21 years of age, inclusive, and skeletally mature.
Patient diagnosed with osteoarthritis of the hip requiring primary total hip resurfacing due to:
Patient is willing to consent to participate in the study
Patient is in stable health and is free of or treated and stabilized for cardiac, pulmonary, hematological, or other conditions that would pose excessive operative risk.
Patient meets medical clearance to have surgery required for this study
Exclusion Criteria:
Patient with infection or sepsis.
Patient with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery.
Patient is pregnant or plans to become pregnant during the course of the study.
Patient known to have insufficient bone stock to support the BHR device including:
Patient has known moderate to severe renal insufficiency. Subjects on medications (such as high-dose or chronic aminoglycoside treatment) or with co-morbidities (such as diabetes) that increase the risk of future, significant renal impairment should be advised of the possibility of increase in systemic metal ion concentration.
Patient has a known sensitivity to materials in the device.
Patient is immuno-suppressed.
Patient has physical, emotional or neurological conditions that would compromise the patient's compliance with postoperative rehabilitation and follow-up.
Patient has BMI >40.
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The patient population considered for this study is patients requiring total hip resurfacing. The following inclusion and exclusion criteria will be used to identify study candidates.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Science Centers | London | Ontario | N6G 1G9 | Canada | ||
| Sr. Michaels Hospital |
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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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| Toronto |
| Ontario |
| M5C 1R6 |
| Canada |