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Recruiting NCT05668182

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

— Observational Tibia Fracture Humerus Fracture Femoral Fracture Long Bone Segmental Defect

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRUMATCH Graft Cage.
Who it may be relevant to
Registry conditions: Tibia Fracture, Humerus Fracture, Femoral Fracture, Long Bone Segmental Defect. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure TRUMATCH Graft Cage
    TRUMATCH Graft Cage for surgical repair of segmental long bone defect

Primary outcome measures

  • Use of the TRUMATCH Graft Cage- Long Bone [Time frame: 2 years]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of California, San Diego — San Diego

Identifiers

NCT: NCT05668182 · 210671

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗