A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects

University of California San Diego

Status: Enrolling

Conditions: Humerus Fracture; Long Bone Segmental Defect; Tibia Fracture; Femoral Fracture

Treatments: Procedure: TRUMATCH Graft Cage

Study type: Observational

Funder types: Other

Identifiers

NCT05668182

210671

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.