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

RecruitingNAAges 70 Years - anyAllJointResearch
NCT04031820 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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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What it tests

  • Unipolar cup
  • Dual mobility cup
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Where

1 site
OLVG
Amsterdam, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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