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.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Netherlands
OLVG
RECRUITING
Amsterdam
Contact Information
Primary
Loes van Beers, MSc
l.w.a.h.vanbeers@olvg.nl
+31205993653
Backup
Nienke Willigenburg, PhD
n.w.willigenburg@olvg.nl
+31205992415
Time Frame
Start Date: 2019-01-01
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 1100
Treatments
Active_comparator: unipolar cup
550 patients will receive a total hip arthroplasty with a unipolar cup.
Active_comparator: Dual Mobility cup
550 patients will receive a total hip arthroplasty with a dual mobility cup.
Related Therapeutic Areas
Sponsors
Leads: JointResearch