Effectiveness of dual-mobility cups for preventing dislocation after primary total hip arthroplasty by a posterolateral approach and their cost-effectiveness compared to unipolar cups in elderly patients.

Phase 4

Recruiting

Conditions: Total hip replacement
hip dislocation
10023213
10005944

Registration Number: NL-OMON54641

Lead Sponsor: Orthopedie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1000

Inclusion Criteria

- Patients who are eligible for elective primary THA with a cemented cup, with
a 32mm or 36mm femoral head, for any indication
- Patients aged >= 70
- Using posterolateral surgical approach.
- Adequate comprehension of written and spoken Dutch

Exclusion Criteria

- Patients unable to complete PROMs
- Patients with dementia, epilepsy*, spasticity*, mental retardation or
alcoholism.
- Patients not eligible for either a unipolar or a DM cup, * these patients
will be asked to participate in the non-randomized dual mobility cohort.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of dislocations, disregarding type of treatment (i.e. closed<br /><br>repositioning or revision).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Revision surgery of any component<br /><br>- Patient Reported Outcome Measures (PROMs)<br /><br>Standard following guidelines of the Dutch orthopaedic association (NOV.<br /><br>Follow-up pre- operative, 3 months and 1 year postoperative. Additional for<br /><br>this study: 2 years postoperative.<br /><br>o HOOS-PS<br /><br>o EQ-5D<br /><br>o NRS-pain rest/weight bearing<br /><br>o Anchor question about change in functioning<br /><br>Added as extra question to the standard PROMs:<br /><br>o Fear of hip dislocation on a 5 point Likert scale<br /><br>* Added at all follow-up moments<br /><br>o Healthcare and societal costs related to hip dislocation or surgery.<br /><br>* Added at 3 months and 1 year postoperative.</p><br>