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

NCT05668182 | Recruiting

• 1 other identifier: 210671
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Use of the TRUMATCH Graft Cage- Long Bone

  2 years

Secondary Outcomes (5)

• Healing Rates

  2 years

• Reoperation Rates

  2 years

• Complications

  2 years

• Pain Scores

  2 years

• Time to Return to Normal Activity

  2 years

Interventions

TRUMATCH Graft Cage PROCEDURE

TRUMATCH Graft Cage for surgical repair of segmental long bone defect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients 18 years or older presenting to UCSD Medical Center with a humerus, femur, or tibia segmental defects requiring surgery

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

RECRUITING

MeSH Terms

Conditions

Tibial Fractures; Humeral Fractures; Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries; Arm Injuries

Central Study Contacts

Dominic Baun, MS

CONTACT

858-534-8268; jbaun@health.ucsd.edu

William Kent, MD

CONTACT

619-543-2694; wkent@health.ucsd.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopaedic Surgery

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 29, 2022
• Study Start: June 29, 2021
• Primary Completion: March 31, 2025
• Study Completion (Estimated): June 29, 2026
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)