Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
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.
JointResearch
1,100 participants
Jan 1, 2019
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria4
- 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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Interventions
Cemented unipolar acetabulum cup for primary THA
Cemented dual mobility acetabulum cup for primary THA
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04031820