Dual Mobility Acetabular Cups in Revision TJA
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 322
- Locations
- 3
- Primary Endpoint
- Prosthetic Dislocation
Study Overview
Brief Summary
The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.
Detailed Description
The aim of this study is to the compare clinical outcomes of patients undergoing a revision total hip arthroplasty (THA) with the use of a dual mobility bearing versus a single bearing design with the use of a large femoral head (36mm or 40mm). We hypothesize the use of dual-mobility components in revision THA will be associated with a lower dislocation rate in the first year following surgery.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Prosthetic Dislocation
Time Frame: 20 years
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Secondary Outcomes
- Routine radiographs assess for loosening and proper component placement(20 years.)
- Complications(up to 20 years after the patient is discharged from the hospital)