Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion
Principal Investigator
by William Kent, MD
Headshot of William Kent
William Kent

Description

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 segemnetal long bone defects, it is imperative to evaluate novel systems to appropriately manage these injuries.

Official Title

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

Keywords

Segmental Long Bone Defect Requiring Surgical Treatment, TRUMATCH Graft Cage

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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.

Location

  • University of California, San Diego accepting new patients
    San Diego California 92093 United States

Lead Scientist at UCSD

  • William Kent, MD
    Assistant Clinical Professor, Orthopedic Surgery, Vc-health Sciences-schools. Authored (or co-authored) 25 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT05668182
Study Type
Observational
Participants
Expecting 5 study participants
Last Updated