Femoral Fracture Clinical Trial
Official title:
Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: a Case Series
| NCT number | NCT05668182 |
| Other study ID # | 210671 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 29, 2021 |
| Est. completion date | June 29, 2026 |
This project consists of a prospective case design. Study candidates will include all patients ages 18 and over who were evaluated at UCSD and found to have a critical-sized humerus, femur, or tibia segmental defect that would be fixed through surgery. Patients who consent to study participation will receive the TRUMATCH Graft Cage for their long bone segmental defect repair. Data on healing rates, complication rates, re-operation rates, time to return to normal activity, and pain levels will be collected for each participation. After 3 years of data collection, we will analyze this data to provide further insight on the utility of the TRUMATCH Graft Cage. Given the significant difficulty with repairing segmental long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.
| Status | Recruiting |
| Enrollment | 5 |
| Est. completion date | June 29, 2026 |
| Est. primary completion date | June 29, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Humerus, femur, or tibia segmental defects requiring surgery - Evaluation and treatment at UCSD - Ages 18 year and older - Abiltiy to understand the content of the patient information/informed consent form Exclusion Criteria: - Any not medically managed severe systemic disease - Their doctor has decided that it is in the patient's best interest to receive a different method of repair - Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study - Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it - Prisoner - Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of California, San Diego |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Use of the TRUMATCH Graft Cage- Long Bone | 2 years | ||
| Secondary | Healing Rates | 2 years | ||
| Secondary | Reoperation Rates | 2 years | ||
| Secondary | Complications | 2 years | ||
| Secondary | Pain Scores | 2 years | ||
| Secondary | Time to Return to Normal Activity | 2 years |
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|---|---|---|---|
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