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Recruiting NCT04031820

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

Trial Parameters

Condition Total Hip Arthroplasty
Sponsor JointResearch
Study Type INTERVENTIONAL
Phase N/A
Enrollment 1,100
Sex ALL
Min Age 70 Years
Max Age N/A
Start Date 2019-01-01
Completion 2026-05-01
Interventions
Unipolar cupDual mobility cup

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.

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