Actively Recruiting
Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
Led by JointResearch · Updated on 2025-02-28
1100
Participants Needed
1
Research Sites
434 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
Who Can Participate
Eligibility Criteria
You may qualify if you...
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.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
OLVG
Amsterdam, Netherlands, 1091 AC
Actively Recruiting
Research Team
L
Loes van Beers, MSc
CONTACT
N
Nienke Willigenburg, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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