Comparing dual-mobility and unipolar cups in hip replacement surgery
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.
NA · JointResearch · NCT04031820
This study is testing whether using dual-mobility hip cups instead of unipolar cups can lower the chances of hip dislocation in patients aged 70 and older after hip replacement surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 70 Years and up |
| Sex | All |
| Sponsor | JointResearch (other) |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT04031820 on ClinicalTrials.gov |
What this trial studies
This study investigates the difference in hip dislocation rates following primary total hip arthroplasty (THA) using dual-mobility (DM) cups versus unipolar cups in patients aged 70 and older. It is a prospective, multi-center, single-blinded randomized controlled trial nested within the Dutch Arthroplasty Register. The primary focus is to assess dislocation rates one year post-surgery, while secondary objectives include evaluating revision rates and cost-effectiveness of the two cup types. The study aims to provide high-quality evidence regarding the effectiveness of DM cups, which have been used in specific patient populations but lack comprehensive evaluation.
Who should consider this trial
Good fit: Ideal candidates are patients aged 70 and older who are eligible for elective primary total hip arthroplasty with a cemented cup.
Not a fit: Patients with cognitive impairments, such as dementia or mental retardation, and those unable to complete patient-reported outcome measures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved stability and reduced dislocation rates in elderly patients undergoing hip replacement surgery.
How similar studies have performed: While dual-mobility cups have been used in specific cases, high-quality evidence from similar studies regarding their effectiveness is limited, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who are eligible for elective primary THA with a cemented cup, with a 32mm or 36 mm liner, for any indication. * THA using posterolateral surgical approach. * Patients ≥ 70 years old * Adequate comprehension of written and spoken Dutch Exclusion Criteria * Patients unable to complete PROMs * Patients with dementia, epilepsy\*, spasticity\*, mental retardation or alcoholism. (If dementia or mental retardation is not already mentioned in the medical chart, this can be determined by doctors opinion.) * Patients not eligible for either a unipolar or a DM cup * These patients will be asked to participate in the non-randomized dual mobility observational cohort.
Where this trial is running
Amsterdam
- OLVG — Amsterdam, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Rudolf Poolman, MD, PhD — OLVG, Amsterdam, the Netherlands
- Study coordinator: Loes van Beers, MSc
- Email: l.w.a.h.vanbeers@olvg.nl
- Phone: +31205993653
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Total Hip Arthroplasty, Osteoarthritis, Hip, Primary total hip arthroplasty, Dual Mobility cup