Comparing dual mobility and single bearing designs in hip revision surgery
Dual Mobility Acetabular Cups in Revision TJA
This study is testing if using dual mobility hip implants instead of single bearing designs can help patients who are having hip revision surgery avoid dislocations in the first year after their operation.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 322 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04090359 on ClinicalTrials.gov |
What this trial studies
This study compares the clinical outcomes of patients undergoing revision total hip arthroplasty (THA) using dual mobility bearings versus single bearing designs with large femoral heads. The hypothesis is that dual mobility components will result in a lower dislocation rate within the first year post-surgery. Patients eligible for this study include those scheduled for various types of revision THA, including conversions from hip resurfacing or hemiarthroplasty. The study aims to provide insights into the effectiveness of dual mobility implants in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are patients over 18 years old scheduled for revision total hip arthroplasty.
Not a fit: Patients undergoing primary THA or those with specific intraoperative decisions for constrained liners may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced dislocation rates in patients undergoing revision hip surgeries.
How similar studies have performed: Other studies have shown promising results with dual mobility implants, suggesting potential benefits in reducing dislocation rates.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient older than 18 years of age scheduled for a revision THA, including revision of both components, conversion of a hip resurfacing to THA, conversion of a hemiarthroplasty to THA, and revision of single components which allow implantation of dual-mobility bearings. In addition, patients undergoing reimplantation of a total hip arthroplasty following a two-stage revision for periprosthetic infection will also be included. Only patients with an acetabular shell diameter capable of accommodating at least a 36mm femoral head will be included. Exclusion Criteria: * Less than 18 years of age, primary THA, * conversion of non-arthroplasty femoral neck fracture fixation to THA, * patients unwilling to participate. * patients where the surgeon makes the intraoperative decision to use a constrained liner will be excluded.
Where this trial is running
New York, New York and 1 other locations
- New York University Medical Center — New York, New York, United States (Not_yet_recruiting)
- Rothman Institute — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Craig Della Valle, MD
- Email: craig.dellavalle@rushortho.com
- Phone: (312)432-2468
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.