CT analysis of the acetabular bone density behind the isoelastic RM press fit cup: Answer for prevention of stress shielding.

• Conditions: failure of the acetabular prosthesis; stress shielding; 10005944

• Registration Number: NL-OMON31842
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Patient selection:
- Unilateral THA
- Diagnosis: primary osteoarthritis (OA)
- No heterolateral complaints / symptoms fitting OA
- Patients should be - Informed consent should be given

Exclusion Criteria

Exclusion criteria*s:
- No bone metabolism diseases
- No anti osteoporotic supplements and oestrogen medications
- Previous acetabular operative reconstructions (Bilateral)
- Post operative complications such as infections, recurrent luxations, acetabular fractures, non compliance with normal post operative care / rehabilitation program.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is bone mineral density (BMD). BMD is determined as<br /><br>the mean mineral content (g/cm3) on a CT, measured in a zone of interest.<br /><br>Measurements are performed 1 week post operative , 6 months and 2 year<br /><br>(primairy endpoint) post operative.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Osteolyses, pain, functional outcome and adverse effects.</p><br>