Health TrialsbyHealthPanel

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

ConditionsTibia FractureHumerus FractureFemoral FractureLong Bone Segmental Defect
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients 18 years or older presenting to UCSD Medical Center with a humerus, femur, or tibia segmental defects requiring surgery

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

  • TRUMATCH Graft Cage

    Procedure/Surgery

    TRUMATCH Graft Cage for surgical repair of segmental long bone defect

Treatment groups

No treatment groups listed

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Source ClinicalTrials.gov
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