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| ID | Type | Description | Link |
|---|---|---|---|
| ACTRN12622001125718 | Registry Identifier | ANZCTR |
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low enrollment
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Prospective, single arm, post-market evaluation to evaluate the use and performance of the IM Implant in a post market setting.
This study will evaluate the use and performance of the Curvafix IM intramedullary system for pelvic fixation in a post-market setting. Study participants will undergo follow-up care per institutional practice and data will then be collected from participant medical records. There will be no active patient participation requirements outside of standard of care. Any follow up evaluations will be documented and reported through 6 months post-implantation. The study will evaluate secondary surgical interventions as a primary study endpoint. Data will also be collected and analyzed for pelvic reduction stability, fracture healing, participant mobility/ambulation, and general health economics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM Implant | Male and female patients who present with a pelvic ring and/or acetabular fracture that has recently undergone surgery to be fixed with a CurvaFix IM Implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM Implant | Device | Patients that have had surgical interventions with one or more IM Implant as part of standard of care for a pelvic and/or acetabular fracture |
|
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Surgical Interventions (SSIs) | Performance will be evaluated based upon the number of Secondary Surgical Interventions (SSIs) that occur within the subject's participation as identified through a review of subject medical records. | 6 months post-implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Mobility | Mobility (ability to advance to weight bearing) assessed by medical record review | 6 months post-implantation |
| Pelvic Reduction Stability | Pelvic reduction stability (ability to maintain reduction over time) assessed by medical record review |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be selected from medical facility study sites that have agreed to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Hebert | Clin-Assist, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Medical Center, Springfield | Springfield | Illinois | 62781 | United States | ||
| Missouri Orthopaedic Institute |
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| 6 months post-implantation |
| Health Economics | General health economics (length of hospital stay) assessed by medical record review | 6 months post-implantation |
| Columbia |
| Missouri |
| 65212 |
| United States |
| Mount Carmel Research Institute | Columbus | Ohio | 43219 | United States |
| University of Pennsylvania, Perelman School of Medicine | Philadelphia | Pennsylvania | 19104 | United States |
| Prisma Health | Columbia | South Carolina | 29203 | United States |
| UT Health San Antonio | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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