Comparing dual-mobility and unipolar cups in hip replacement surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.