Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age70+
SponsorJointResearch
About this trial
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
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Unipolar cup
- Dual mobility cup
Treatment groups
1,100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov