- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05668182
A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects
February 5, 2026 updated by: William Kent, University of California, San Diego
Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: A Case Series
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
5
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dominic Baun, MS
- Phone Number: 858-534-8268
- Email: jbaun@health.ucsd.edu
Study Contact Backup
- Name: William Kent, MD
- Phone Number: 619-543-2694
- Email: wkent@health.ucsd.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92093
- Recruiting
- University of California, San Diego
-
Contact:
- Dominic Baun, MS
- Phone Number: 858-534-8268
- Email: jbaun@health.ucsd.edu
-
Principal Investigator:
- William Kent, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Use of the TRUMATCH Graft Cage- Long Bone
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Healing Rates
Time Frame: 2 years
|
2 years
|
|
Reoperation Rates
Time Frame: 2 years
|
2 years
|
|
Complications
Time Frame: 2 years
|
2 years
|
|
Pain Scores
Time Frame: 2 years
|
2 years
|
|
Time to Return to Normal Activity
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 29, 2021
Primary Completion (Actual)
March 31, 2025
Study Completion (Estimated)
June 29, 2026
Study Registration Dates
First Submitted
December 19, 2022
First Submitted That Met QC Criteria
December 19, 2022
First Posted (Actual)
December 29, 2022
Study Record Updates
Last Update Posted (Actual)
February 9, 2026
Last Update Submitted That Met QC Criteria
February 5, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 210671
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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