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Targeted Muscle Reinnervation for Amputees (TMR Trial)

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
Screening 3 weeks
Treatment Varies
Follow Up pre-operative through 24 months
Awards & highlights

TMR Trial 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.Check my eligibility
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.See study design
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.

TMR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am 18 or older and need a leg amputation.

TMR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effect of TMR on neuroma
Effect of TMR on phantom limb pain

TMR 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Targeted Muscle Reinnervation

Find a Location

Who is running the clinical trial?

Joshua HustedtLead Sponsor
Joshua Hustedt, MD, MHSPrincipal InvestigatorUniversity of Arizona

Media Library

Targeted Muscle Reinnervation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05408520 — N/A
Amputation Research Study Groups: Amputation with TMR, Amputation without TMR (SOC)
Amputation Clinical Trial 2023: Targeted Muscle Reinnervation Highlights & Side Effects. Trial Name: NCT05408520 — N/A
Targeted Muscle Reinnervation (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05408520 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What eligibility criteria must one fulfill to participate in this experiment?

"This clinical trial will include 50 participants with lower limb amputations between 18 and 99 years old. Candidates must meet the following criteria to be eligible: Individuals aged 18 or above that have been indicated for an amputation at Banner-University Medical Center Phoenix, either below knee or above knee."

Answered by AI

Are there any remaining openings to participate in this experiment?

"Clinicaltrials.gov confirms that enrolment for this trial is ongoing, with the initial post dating back to December 1st 2022 and recent edits occurring on October 23rd of the same year."

Answered by AI

Does this research endeavor accept individuals of advanced age?

"This research is inviting patients aged 18 years or greater but younger than 99 to apply."

Answered by AI

How many participants has this trial recruited thus far?

"Affirmative. The clinicaltrials.gov registry shows that this experiment is actively looking for participants, having been first posted on December 1st 2022 and edited as recently as October 23rd 2022. A total of 50 individuals will be enrolled at a single medical facility."

Answered by AI
Recent research and studies
~25 spots leftby May 2025