Assessing the safety and performance of a hip resurfacing prosthesis compared with a conventional total hip prosthesis in relatively young males with primary arthritis; a prospective, controlled clinical study.

Completed

• Conditions: coxarthrosis; Arthritis of the hip; osteoarthitis; 10023213

• Registration Number: NL-OMON41141
• Lead Sponsor: Kliniek Orthopedium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Male patients between 18 and 60 years of age
2.Patients requiring primary hip replacement
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>- UCLA activity score<br /><br>- Incidence of device related adverse 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<br /><br>- Osteoarthritis Outcome Score (HOOS) over time<br /><br>- Evaluation of cobalt blood concentrations over time<br /><br>- Evaluation of the acetabular component positioning by X-ray</p><br>