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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 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

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
~10 spots leftby May 2025
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