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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

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

Select...

I am 18 or older and need a leg amputation.

TMR Trial 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

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Targeted Muscle Reinnervation

2014

N/A

~60

0 / 1Eligibility criteria met

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

Plastic and Reconstructive SurgeryJournal

Targeted Muscle Reinnervation Technique in Below-knee Amputation

Bowen, J. Byers, Daniel Ruter, Corinne Wee, Julie West, and Ian L. Valerio. 2019. “Targeted Muscle Reinnervation Technique in Below-knee Amputation”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/prs.0000000000005133.

Prosthetics & Orthotics InternationalJournal

The Use of Targeted Muscle Reinnervation for Improved Myoelectric Prosthesis Control in a Bilateral Shoulder Disarticulation Amputee

Kuiken, T. A., G. A. Dumanian, R. D. Lipschutz, L. A. Miller, and K. A. Stubblefield. 2004. “The Use of Targeted Muscle Reinnervation for Improved Myoelectric Prosthesis Control in a Bilateral Shoulder Disarticulation Amputee”. Prosthetics & Orthotics International. Ovid Technologies (Wolters Kluwer Health). doi:10.3109/03093640409167756.

Archives of Physical Medicine and RehabilitationJournal

Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050

Ziegler-Graham, Kathryn, Ellen J. MacKenzie, Patti L. Ephraim, Thomas G. Travison, and Ron Brookmeyer. 2008. “Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050”. Archives of Physical Medicine and Rehabilitation. Elsevier BV. doi:10.1016/j.apmr.2007.11.005.

Advances in Wound CareJournal