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NCT Number: NCT05668182

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

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.

Recruiting

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Key information

Conditions

Tibia Fracture Arm Injuries Femoral Fracture Femoral Fractures Fractures, Bone Humeral Fractures Humerus Fracture Leg Injuries Long Bone Segmental Defect Tibial Fractures Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Diego

San Diego, California, 92093, United States

Location status: Recruiting

Location contact

Dominic Baun, MS

CONTACT

[email protected]

858-534-8268

William Kent, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRUMATCH Graft Cage

Procedure

TRUMATCH Graft Cage for surgical repair of segmental long bone defect

Primary outcomes

  1. Use of the TRUMATCH Graft Cage- Long Bone

    Time frame: 2 years

Secondary outcomes

  1. Healing Rates

    Time frame: 2 years

  2. Reoperation Rates

    Time frame: 2 years

  3. Complications

    Time frame: 2 years

  4. Pain Scores

    Time frame: 2 years

  5. Time to Return to Normal Activity

    Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Dominic Baun, MS

CONTACT

[email protected]

858-534-8268

William Kent, MD

CONTACT

[email protected]

619-543-2694

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Dec 29, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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