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Targeted Muscle Reinnervation for Amputees (TMR Trial)

N/A

Waitlist Available

Led By Joshua Hustedt, MD, MHS

Research Sponsored by Joshua Hustedt

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any individual 18 years and older indicated for a below knee or above knee amputation at Banner-University Medical Center Phoenix

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-operative through 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will help researchers understand if targeted muscle reinnervation, a treatment for amputees, is effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the specific side effects are not detailed, TMR involves surgery which can typically include pain, swelling, infection risk, and possible nerve issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 or older and need a leg amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-operative through 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-operative through 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-operative through 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Effect of TMR on neuroma

Effect of TMR on phantom limb pain

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Amputation with TMRExperimental Treatment1 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 Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Targeted Muscle Reinnervation

2014

N/A

~60

0 / 1Eligibility criteria met