Dual Mobility Acetabular Cups in Revision TJA
- Conditions
- Dislocation, Hip
- Interventions
- Device: Conventional, single-bearing implantDevice: Dual Mobility Implant
- Registration Number
- NCT04090359
- Lead Sponsor
- Rush University Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 322
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Conventional, Single-bearing hip implant Conventional, single-bearing implant If patients are randomized to the conventional, single bearing cohort, surgeons will use their preferred implant design at their discretion using a 36 or 40mm head, depending on the diameter of the cup and manufacturer specifications. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized. Dual Mobility Dual Mobility Implant If patients are randomized to the dual mobility cohort, they will receive a dual mobility prosthesis at the surgeon's discretion. All surgeries will be performed via the posterior approach, per the participating surgeon's usual standard. Patients will be on postoperative hip precautions for 6 weeks, per departmental protocol. No braces will be utilized.
- Primary Outcome Measures
Name Time Method Prosthetic Dislocation 20 years The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
- Secondary Outcome Measures
Name Time Method Routine radiographs assess for loosening and proper component placement 20 years. Routine radiographs (AP Pelvis, frogleg lateral, and cross-table lateral radiographs) will be obtained at follow-up visits and assessed for cup placement, anteversion, radiographic signs of loosening, and component migration. Radiographics will be assessed for loosening in a yes/no way.
Complications up to 20 years after the patient is discharged from the hospital Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates
Trial Locations
- Locations (2)
New York University Medical Center
🇺🇸New York, New York, United States
Rothman Institute
🇺🇸Philadelphia, Pennsylvania, United States