Fully Constrained Acetabular Liner Versus Dual Mobility Hip Joint in the Surgical Treatment of Metastatic Bone Disease of the Hip - A Randomized, Open-Label, Two-Arm, Non-Inferiority Study Evaluating the Post-Operative Hip Dislocation Rate
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of the current study is to investigate whether dual mobility liners are non-inferior til constrained liners regarding the post-operative hip joint dislocation risk following total hip replacement in patients with metastatic bone disease of the hip.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Diagnosed with metastatic bone disease of the hip defined as bone lesions in the proximal femur because of secondary malignant growth of a primary cancer located elsewhere or bone lesions in the proximal femur due to hematological malignancies
• Determined eligible for total hip arthroplasty for metastatic bone disease of the hip and is planned to undergo surgery at the study site
• Provides informed consent prior to initiation of any study-specific activities/procedures
Locations
Other Locations
Denmark
Department of Orthopedic Surgery, Rigshospitalet
RECRUITING
Copenhagen
Contact Information
Primary
Afrim Iljazi, MD
afrim.iljazi.04@regionh.dk
+4535456125
Time Frame
Start Date: 2022-09-20
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 146
Treatments
Other: Constrained Liner
Other: Dual Mobility Cup
Related Therapeutic Areas
Sponsors
Leads: Rigshospitalet, Denmark