Dual-mobility Cups Compared to Unipolar Cups on Dislocation and Cost-effectiveness After Primary Total Hip Arthroplasty.
Recruiting · NCT04031820 · Interventional (participants receive a specific treatment) · Lead sponsor: JointResearch
View the official record on ClinicalTrials.gov →Interventions studied
Dual mobility cupUnipolar cup
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.
Who can take part
Age range
70 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- OLVG - Amsterdam, Netherlands