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

Femoral Fracture Clinical Trial

Official title:

Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: a Case Series

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05668182
• Other study ID #: 210671
• Status: Recruiting
• Start date: June 29, 2021
• Est. completion date: June 29, 2026

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: Dominic Baun, MS
• Phone: 858-534-8268
• Email: jbaun[@]health.ucsd.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Femoral Fracture
• Femoral Fractures
• Fractures, Bone
• Humeral Fractures
• Humerus Fracture
• Tibia Fracture
• Tibial Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Outcome

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