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| Name | Class |
|---|---|
| New York University | OTHER |
| Rothman Institute Orthopaedics | OTHER |
| Keck School of Medicine of USC | OTHER |
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The aim of this study is to compare clinical outcomes of patients considered to be high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single bearing design.
This study aims to compare the clinical outcomes of patients considered to be at high risk for prosthetic dislocation undergoing primary total hip arthroplasty (THA) with the use of a dual mobility bearing versus a conventional, single-bearing design.
We hypothesize that in primary THA patients considered to be at high risk for prosthetic dislocation, the use of dual-mobility components will be associated with a lower dislocation rate in the first year following the index procedure. We do not anticipate a difference. In other clinical outcome measures or functional outcome scores between the two cohorts.
Study Design: Randomized controlled trial with two groups: THA with dual mobility.
44 components vs THA with single-bearing designs
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual mobility | Experimental | Patients in this group will receive a dual mobility hip implant |
|
| Single bearing, traditional hip implant | Active Comparator | Patients in this group will receive a traditional, single-bearing hip implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dual mobility implant | Device | Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant |
| Measure | Description | Time Frame |
|---|---|---|
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 6 weeks following their index surgical procedure. |
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 1 year following their index surgical procedure. |
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 2 years following their index surgical procedure. |
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 5 years following their index surgical procedure. |
| Hip Dislocation | The rate of prosthetic dislocation between the two cohorts | 10 years following their index surgical procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Complications | Any peri- or postoperative complications will be recorded component loosening, occurrence of intraprosthetic dislocation, infection, periprosthetic fractures, revision rates | Complications will be assess up to 10 years following their index surgical procedure |
| Radiographic signs of loosening and proper component placement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck School of Medicine of USC | Los Angeles | California | 90033 | United States | ||
| Rush University Medical Center |
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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: THA with dual mobility components vs THA with single-bearing designs.
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| Traditional, Single-bearing hip implant | Device | Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility 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. These radiographs will be assess for the presence of loosening in a yes/no format |
| 6 weeks following their index surgical procedure. |
| Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format | 1 year following their index surgical procedure. |
| Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format | 2 years following their index surgical procedure. |
| Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format | 5 years following their index surgical procedure. |
| Radiographic signs of 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. These radiographs will be assess for the presence of loosening in a yes/no format | 10 years following their index surgical procedure. |
| Chicago |
| Illinois |
| 60612 |
| United States |
| New York University Medical Center | New York | New York | 10003 | United States |
| Rothman Orthopaedic Institute | Philadelphia | Pennsylvania | 19107 | United States |
| D025981 |
| Hip Injuries |