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| Name | Class |
|---|---|
| Rothman Institute Orthopaedics | OTHER |
| Keck School of Medicine of USC | OTHER |
| NYU Langone Health | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual Mobility | Experimental | 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. |
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| Conventional, Single-bearing hip implant | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual Mobility Implant | Device | Patients in this intervention will receive a dual mobility implant |
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| Measure | Description | Time Frame |
|---|---|---|
| Prosthetic Dislocation | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits | 6 weeks |
| Prosthetic Dislocation | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits | 3 months |
| Prosthetic Dislocation | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits | 2 years |
| Prosthetic Dislocation | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits | 5 years |
| Prosthetic Dislocation | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits | 10 years |
| Prosthetic Dislocation | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits | 15 years |
| Prosthetic Dislocation | The rate of prosthetic dislocation between the two cohorts will be measured at standard postoperative clinic visits | 20 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Any peri- or postoperative complications will be recorded, including component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates | up to 20 years after the patient is discharged from the hospital |
| Routine radiographs assess for loosening and proper component placement |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Craig Della Valle, MD | Contact | (312)432-2468 | craig.dellavalle@rushortho.com | |
| Anne DeBenedetti, BA | Contact | (312)432-2468 | anne.debenedetti@rushortho.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University Medical Center | Not yet recruiting | New York | New York | 10003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37019309 | Derived | Weintraub MT, DeBenedetti A, Nam D, Darrith B, Baker CM, Waren D, Schwarzkopf R, Courtney PM, Della Valle CJ. Dual-Mobility versus Large Femoral Heads in Revision Total Hip Arthroplasty: Interim Analysis of a Randomized Controlled Trial. J Arthroplasty. 2023 Jul;38(7S):S206-S210. doi: 10.1016/j.arth.2023.03.089. Epub 2023 Apr 3. |
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| ID | Term |
|---|---|
| D006617 | Hip Dislocation |
| ID | Term |
|---|---|
| D004204 | Joint Dislocations |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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Randomized controlled trial with two groups: revision THA with dual mobility components vs revision THA with large head, single bearing designs (36mm and 40mm).
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| Conventional, single-bearing implant | Device | Patients in this intervention will receive a conventional, single-bearing implant |
|
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. |
| 6 weeks |
| Routine radiographs assess for loosening and proper component placement | 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. | 3 months |
| Routine radiographs assess for loosening and proper component placement | 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. | 2 years |
| Routine radiographs assess for loosening and proper component placement | 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. | 5 years |
| Routine radiographs assess for loosening and proper component placement | 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. | 10 years |
| Routine radiographs assess for loosening and proper component placement | 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. | 15 years |
| Routine radiographs assess for loosening and proper component placement | 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. | 20 years. |
| Rothman Institute | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| D025981 |
| Hip Injuries |