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Clinical Trials in the Netherlands / NCT04031820
Recruiting Not applicable

Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.

NCT04031820 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2019-01-01
Last updated
2025-02-28

Condition(s) studied

Total Hip ArthroplastyOsteoarthritis, Hip

Investigational drug(s) / intervention(s)

Unipolar cupDual mobility cup

Unipolar cup: Cemented unipolar acetabulum cup for primary THA

Dual mobility cup: Cemented dual mobility acetabulum cup for primary THA

Study 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

Sex
ALL
Min age
70 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
OLVG Amsterdam Netherlands Recruiting

More JointResearch trials in the Netherlands

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04031820 on ClinicalTrials.gov ↗ ← All trials in the Netherlands