Femoral Fracture, Humerus Fracture, Long Bone Segmental Defect, Tibia Fracture
Conditions
Brief summary
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.
Interventions
PROCEDURETRUMATCH Graft Cage
TRUMATCH Graft Cage for surgical repair of segmental long bone defect
Sponsors
University of California, San Diego
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Use of the TRUMATCH Graft Cage- Long Bone | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Healing Rates | 2 years |
| Reoperation Rates | 2 years |
| Complications | 2 years |
| Pain Scores | 2 years |
| Time to Return to Normal Activity | 2 years |
Countries
United States
Contacts
CONTACTDominic Baun, MS
CONTACTWilliam Kent, MD
Outcome results
None listed