Status:
COMPLETED
Clinical Outcome of Birmingham Hip Resurfacing (BHR) Using VISIONAIRE Femoral Alignment Guide
Lead Sponsor:
Smith & Nephew, Inc.
Conditions:
Osteoarthritis
Eligibility:
All Genders
18-75 years
Brief Summary
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 postope...
Detailed Description
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 ef...
Eligibility Criteria
Inclusion
- 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:
- Non-inflammatory arthritis (degenerative joint disease) such as osteoarthritis, traumatic arthritis, avascular necrosis, or dysplasia/DDH, or
- Inflammatory arthritis such as rheumatoid arthritis.
- 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
- 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:
- Subjects with severe osteopenia should not receive a BHR procedure. Patients with a family history of severe osteoporosis or severe osteopenia.
- Subjects with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT Grade) should not receive a BHR.
- Subjects with multiple cysts of the femoral head (\>1cm) should not receive a BHR.
- Note: In cases of questionable bone stock, a DEXA scan may be necessary to assess inadequate bone stock.
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01427361
Start Date
October 1 2009
End Date
August 1 2011
Last Update
March 22 2018
Active Locations (2)
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1
London Health Science Centers
London, Ontario, Canada, N6G 1G9
2
Sr. Michaels Hospital
Toronto, Ontario, Canada, M5C 1R6