Evaluation of the safety and efficacy of the MHP- total hip arthroplasty
Completed
- Conditions
- hip artrosiship wear10005944
- Registration Number
- NL-OMON50762
- Lead Sponsor
- Zimmer Biomet
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
Inclusion Criteria
1. Candidates for a total hip replacement because of arthritis of the hip.
2. Patients with a good general condition.
3. Patients willing and able to participate in the clinical trial with a 10
years follow up and who have signed an informed consent.
4. Males and females.
5. Age between 55 and 75.
6. Absence or little presence of osteoporotic bone (t>-2).
7. ASA score 1 and 2.
Exclusion Criteria
Severe comorbidities
Infection
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- - Stability measured with RSA at discharge, 3, 6, 12 and 24 months<br /><br>postoperative.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Safety defined as absence of serious device related complications.<br /><br>- Efficacy defined as functional outcome measured with HHS and the HOOS<br /><br>preoperatively, 6 weeks, 3, 6 and 12 months and subsequently annually until 7<br /><br>years postoperatively and at 10 years postoperatively.<br /><br>- Bone density measured using DEXA preoperative and 6 weeks, 1 and 2 10 years<br /><br>postoperative.<br /><br>- Quality of life measured with the SF12 preoperatively, 6 weeks, 3, 6 and 12<br /><br>months and subsequently annually until 7 years postoperatively and at 10 years<br /><br>postoperatively..</p><br>