NL-OMON38532
Withdrawn
Not Applicable
A prospective, single arm, open label study assessing the performance and safety of the Birmingham Hip Resurfacing system in relatively young males with primary arthritis of the hip requiring hip replacement. - BHR studie
Kliniek Orthopedium0 sites100 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Kliniek Orthopedium
- Enrollment
- 100
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Male patients between 18 and 60 years of age
- •2\.Patients requiring hip replacement, suitable for the use of the BHR system
- •3\.Patients with an endstage of primary arthritis of the hip
- •4\.Patients with a femoral head \* 50 mm (as measured by calibrated X\-ray imaging)
Exclusion Criteria
- •1\.Patients with a BMI \>35
- •2\.Patients with infection or sepsis
- •3\.Patients with bone stock inadequate to support the device including:
- •a.Patients with severe osteopenia or with a family history of severe osteoporosis or severe osteopenia
- •b.Patients with osteonecrosis or avascular necrosis (AVN) with \>50% involvement of the femoral head (regardless of FICAT grade)
- •c.Patients with multiple cysts of the femoral head (\> 1cm)
- •4\.Patients with known moderate to severe renal insufficiency
- •5\.Patients who are immunologically suppressed with diseases such as AIDS, or patients who are receiving corticosteroids in high doses
- •6\.Patients with known or suspected metal sensitivity
- •7\.Patients who are skeletally immature
Outcomes
Primary Outcomes
Not specified
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