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

NCT ID: NCT05668182

Last Updated: 2024-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-29

Study Completion Date

2026-06-29

Brief Summary

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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.

Detailed Description

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Conditions

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Tibia Fracture Humerus Fracture Femoral Fracture Long Bone Segmental Defect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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TRUMATCH Graft Cage

TRUMATCH Graft Cage for surgical repair of segmental long bone defect

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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William Kent

Assistant Professor of Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of California, San Diego

San Diego, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Dominic Baun, MS

Role: CONTACT

858-534-8268

William Kent, MD

Role: CONTACT

619-543-2694

Facility Contacts

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Dominic Baun, MS

Role: primary

858-534-8268

William Kent, MD

Role: backup

Other Identifiers

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210671

Identifier Type: -

Identifier Source: org_study_id

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