Comparing two types of hip joint liners for patients with metastatic bone disease
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
This study tests whether a new type of hip joint liner can help prevent dislocations after hip replacement surgery for patients with metastatic bone disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT05461313 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of dual mobility liners compared to constrained liners in preventing hip joint dislocation after total hip replacement in patients with metastatic bone disease. The research focuses on a high-risk population where dislocation is a significant concern. By evaluating the post-operative outcomes, the study aims to determine if dual mobility liners can provide a safer alternative without compromising joint stability. Participants will be monitored for dislocation rates following surgery.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with metastatic bone disease of the hip who are eligible for total hip arthroplasty.
Not a fit: Patients who have had previous surgeries on the same hip or those who cannot undergo the surgical procedure will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced dislocation rates for patients undergoing hip replacement due to metastatic bone disease.
How similar studies have performed: Previous studies have shown success with dual mobility cups in other high-risk hip surgeries, suggesting potential for similar outcomes in this population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Previous osteosynthesis or endoprosthetic surgery of the ipsilateral hip * Pelvic reconstruction of the ipsilateral hip * Total femoral replacement of the ipsilateral femur * It is not surgically viable to insert an acetabular cup and/or a femoral stem * Subject is currently or has previously been enrolled in this study * Subject is incapable of understanding the patient information or unable to provide informed consent
Where this trial is running
Copenhagen
- Department of Orthopedic Surgery, Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Principal investigator: Afrim Iljazi, MD — Rigshospitalet, Denmark
- Study coordinator: Afrim Iljazi, MD
- Email: afrim.iljazi.04@regionh.dk
- Phone: +4535456125
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.