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.

Withdrawn

Conditions: Arthritis of the hip
coxarthrosis
osteoarthitis
10023213

Registration Number: NL-OMON38532

Lead Sponsor: Kliniek Orthopedium

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 100

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
8.Patients with any vascular insufficiency, muscular atrophy, or neuromuscular disease severe enough to compromise implant stability or postoperative recovery
9. Patients suffering from diabetes type I or II

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure for efficacy in this study is the Oxfrd Hip Score.<br /><br>This is a common outcome measure for this type of studies as shown in<br /><br>literature.<br /><br>The safety outcome is defined as the incidence of device related adverse<br /><br>events.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>* Evaluation of overall survival of the BHR<br /><br>* Evaluation of quality of life, as assessed by the EQ-5D score, the Harris Hip<br /><br>Score (HHS) and the Hip disability and Osteoarthritis Outcome Score (HOOS)<br /><br>over time<br /><br>* Evaluation of cobalt blood concentrations over time<br /><br>* Evaluation of the acetabular component positioning by X-ray</p><br>