Targeted Muscle Reinnervation for Amputees

(TMR Trial)

Overseen By Anna Valencia, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Joshua Hustedt

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the effect of targeted muscle reinnervation on the outcomes of amputees at a level 1 trauma center. The investigators propose to randomize all patients requiring amputation with and without targeted muscle reinnervation. This study will help delineate the efficacy of targeted muscle reinnervation in the general population.

Research Team

Joshua Hustedt, MD, MHS

Principal Investigator

University of Arizona

Eligibility Criteria

This trial is for adults over 18 who need a below knee or above knee amputation at Banner-University Medical Center Phoenix. It's not open to those who don't meet these requirements.

Inclusion Criteria

I am 18 or older and need a leg amputation.

Exclusion Criteria

Any individual who does not meet inclusion criteria

Treatment Details

Interventions

• Targeted Muscle Reinnervation

Trial Overview The study is testing the effectiveness of targeted muscle reinnervation (TMR) in improving outcomes for amputees. Participants will be randomly assigned to receive TMR or not during their amputation surgery.

Participant Groups

Group I: Amputation with TMR Experimental Treatment 1 Intervention

Amputation will follow standard procedure, but with the addition of the TMR procedure, which involves rerouting severed or injured nerves to new muscle targets using microsurgical techniques to provide the nerve endings with a new muscle to innervate.

Group II: Amputation without TMR (SOC) Active Control 1 Intervention

A traditional amputation follows the normal standard of care, with transection of peripheral nerves.

Who Is Running the Clinical Trial?

Joshua Hustedt

Lead Sponsor

Trials

1

Recruited

50+