Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
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- Who runs it
- JointResearch
- Trial code
- NCT04031820
- Record updated
- 28 February 2025
- Original description
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.Read full original descriptionShow less
Effectiveness of Dual-mobility Cups for Preventing Dislocation After Primary Total Hip Arthroplasty by a Posterolateral Approach and Their Cost-effectiveness Compared to Unipolar Cups in Elderly Patients.
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.
Inclusion: 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: 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 unable to complete PROMs; 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.