NCT04031820 Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
| NCT ID | NCT04031820 |
| Status | Recruiting |
| Phase | — |
| Sponsor | JointResearch |
| Condition | Total Hip Arthroplasty |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,100 participants in total. It began in 2019-01-01 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: The primary objective is to investigate whether there is a difference in the number of hip dislocations following primary total hip arthroplasty (THA), using the posterolateral approach, with a DM cup compared to a unipolar cup in elderly patients 1 year after surgery. Study design: Prospective multi-center nation wide, single blinded RCT nested in the LROI. Study population: Patients ≥ 70 years old, undergoing an elective primary cemented THA.
Eligibility 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.
Contact & Investigator
Rudolf Poolman, MD, PhD
PRINCIPAL INVESTIGATOR
OLVG, Amsterdam, the Netherlands
Frequently Asked Questions
Who can join the NCT04031820 clinical trial?
This trial is open to participants of all sexes, aged 70 Years or older, studying Total Hip Arthroplasty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04031820 currently recruiting?
Yes, NCT04031820 is actively recruiting participants. Contact the research team at l.w.a.h.vanbeers@olvg.nl for enrollment information.
Where is the NCT04031820 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT04031820 clinical trial?
NCT04031820 is sponsored by JointResearch. The principal investigator is Rudolf Poolman, MD, PhD at OLVG, Amsterdam, the Netherlands. The trial plans to enroll 1,100 participants.