Dual Mobility Acetabular Cups in Revision TJA
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Dual Mobility 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. |
Device: Dual Mobility Implant
Patients in this intervention will receive a dual mobility implant
|
| Active Comparator: Conventional, Single-bearing hip 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. |
Device: Conventional, single-bearing implant
Patients in this intervention will receive a conventional, single-bearing implant
|
Outcome Measures
Primary Outcome Measures
- Prosthetic Dislocation [6 weeks]
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
- Prosthetic Dislocation [3 months]
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
- Prosthetic Dislocation [2 years]
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
- Prosthetic Dislocation [5 years]
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
- Prosthetic Dislocation [10 years]
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
- Prosthetic Dislocation [15 years]
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
- Prosthetic Dislocation [20 years]
The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits
Secondary Outcome Measures
- 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
- Routine radiographs assess for loosening and proper component placement [6 weeks]
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.
- Routine radiographs assess for loosening and proper component placement [3 months]
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.
- Routine radiographs assess for loosening and proper component placement [2 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.
- Routine radiographs assess for loosening and proper component placement [5 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.
- Routine radiographs assess for loosening and proper component placement [10 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.
- Routine radiographs assess for loosening and proper component placement [15 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.
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University Medical Center | New York | New York | United States | 10003 |
| 2 | Rothman Institute | Philadelphia | Pennsylvania | United States | 19107 |
Sponsors and Collaborators
- Rush University Medical Center
- Rothman Institute Orthopaedics
- NYU Langone Health
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 17022801