Tibia FractureNCT05668182
A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects
An observational study of Tibia Fracture and Humerus Fracture, run by University of California, San Diego at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tibia Fracture, Humerus Fracture, Femoral Fracture
- What is being tested?
- TRUMATCH Graft Cage
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 29 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients 18 years or older presenting to UCSD Medical Center with a humerus, femur, or tibia segmental defects requiring surgery
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California, San Diego
San Diego, California, 92093
Dominic Baun, MS, 858-534-8268, jbaun@health.ucsd.edu
William Kent, MD
About this study
Official title: 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.
- Being tested
- TRUMATCH Graft Cage
- Medical subject headings
- Tibial Fractures, Humeral Fractures, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRUMATCH Graft CageProcedure or surgery
TRUMATCH Graft Cage for surgical repair of segmental long bone defect
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of the TRUMATCH Graft Cage- Long Bone
Measured: 2 years
Secondary outcomes (5)
Healing Rates
Measured: 2 years
Reoperation Rates
Measured: 2 years
Complications
Measured: 2 years
Pain Scores
Measured: 2 years
Time to Return to Normal Activity
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start29 Jun 2021
- Primary completion31 Mar 2025
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tibia FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Kent, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668182
- Sponsor's protocol ID
- 210671
- Status last verified
- Feb 2026
- First submitted
- 19 Dec 2022
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes Utilizing the TRUMATCH Graft Cage for Segmental Long Bone Defects: A Case Series
- ClinicalTrials.gov ID
- NCT05668182
- Acronym / sponsor ID
- 210671
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 29 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients 18 years or older presenting to UCSD Medical Center with a humerus, femur, or tibia segmental defects requiring surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRUMATCH Graft CageTRUMATCH Graft Cage for surgical repair of segmental long bone defect | Procedure or surgery | – |
Primary outcome
Use of the TRUMATCH Graft Cage- Long Bone
Time frame: 2 years
5 secondary outcomes
Healing Rates
Time frame: 2 years
Reoperation Rates
Time frame: 2 years
Complications
Time frame: 2 years
Pain Scores
Time frame: 2 years
Time to Return to Normal Activity
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tibia Fracture and Humerus Fracture, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dominic Baun, MS (858-534-8268, jbaun@health.ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of the TRUMATCH Graft Cage- Long Bone (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.