Status:
RECRUITING
Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
Lead Sponsor:
JointResearch
Conditions:
Total Hip Arthroplasty
Osteoarthritis, Hip
Eligibility:
All Genders
70+ years
Phase:
NA
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, wi...
Detailed Description
Rationale: Dislocation is the leading reason for early revision surgery. To address the problem of dislocation, the dual-mobility (DM) cup was developed in France in the 1970's. This cup should provid...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT04031820
Start Date
January 1 2019
End Date
May 1 2027
Last Update
February 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
OLVG
Amsterdam, Netherlands, 1091 AC