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NCT05668182
A Case Series: TRUMATCH Graft Cage for Segmental Long Bone Defects
Conditions: Segmental Long Bone Defect Requiring Surgical Treatment
Sex: All
Ages: 18 Years – N/A
Enrollment: 5
Sponsor: University of California, San Diego
Location: United States
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.
Eligibility Criteria
Inclusion Criteria:Humerus, femur, or tibia segmental defects requiring surgeryEvaluation and treatment at UCSDAges 18 year and olderAbiltiy to understand the content of the patient information/informed consent formExclusion Criteria:Any not medically managed severe systemic diseaseTheir doctor has decided that it is in the patient's best interest to receive a different method of repairTheir doctor has determined that the patient has a condition that would make them unsuitable for participation in the studyPregnancy 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 itPrisonerParticipation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study.
Source: ClinicalTrials.gov (NCT05668182). StuddyBuddy aggregates publicly available trial information.