Targeted Muscle Reinnervation Study (TMR)

Not Applicable

• Conditions: Amputation
• Interventions: Procedure: Targeted Muscle Reinnervation

• Registration Number: NCT05408520
• Lead Sponsor: Joshua Hustedt

Brief Summary

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.

Detailed Description

After an amputation, patients often experience pain, both from the cut nerves themselves as well as perceived pain from a 'missing' limb. A technique has been developed to regenerate the cut nerve so that it doesn't cause pain. The technique includes sewing the nerve into another nerve so that it continues to function. This technique, called targeted muscle reinnervation, can reduce the postoperative pain amputee patients experience.

Targeted muscle reinnervation (TMR) has shown promising success in the reduction of neuroma and phantom limb pain following extremity amputation. TMR was originally designed to allow for regenerative neurotization of end target muscle for the purpose of utilizing myoelectric prosthesis for amputees. While these indications have been successful, it has been the secondary outcome of reduction in neuroma and phantom limb pain that have led to significant improvements in patient outcomes.

In the United States there are 200,000 amputations every year, and 1.6 million Americans living as amputees. Despite the technical success of the procedures, over 75% of patients will experience neuroma pain, and 85% will experience phantom limb pain. In addition, this pain limits the postoperative ambulation of many patients leading to a 75% 5-year mortality rate for patients who undergo lower extremity amputation in the US.3 TMR has shown promising clinical results in addressing phantom limb and neuroma pain. In pooled data it showed that patients who underwent TMR had residual limb pain of 0% and phantom limb pain of 7%. In a larger comparative study of 489 patients, patients who underwent TMR had phantom limb pain scores with an average of 1, compared to an average of 5 for control amputees. The TMR patients also had an average residual limb pain of 1, compared to an average of 4 for controls.

Yet despite these promising outcomes, questions with TMR still remain. In the Valerio study, the largest study to date, all patients were grouped together regardless of the reason for amputation. While the percentage of patients undergoing amputation for cancer, infection, ischemia, trauma, or other, was reported, there was no comparison of outcomes in these groups. In a new study, the benefits of TMR have been shown to hold in highly comorbid patients presenting to a level 1 trauma center. Given the outcomes of TMR in these studies, there seems to be strong evidence to encourage the procedure, yet no study has yet to randomize patients to measure the true clinical outcome in a trauma population.

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-06-03
• Study First Posted: 2022-06-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-17
• Last Update Posted: 2023-04-19
• Study Start: 2023-05
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Any individual who does not meet inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amputation with TMR	Targeted Muscle Reinnervation	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.

Primary Outcome Measures

Name	Time	Method
Effect of TMR on neuroma	Pre-operative through 24 months	Subject data will be collected from EMR and patient reported outcome surveys, rating pain on a scale of 1-10 (1 being no pain and 10 being the worst pain).
Effect of TMR on phantom limb pain	Pre-operative through 24 months	Subject data will be collected from EMR and patient reported outcome surveys, rating pain on a scale of 1-10 (1 being no pain and 10 being the worst pain).

Trial Locations

Locations (1)

Banner - University Medical Center, Phoenix campus; 🇺🇸 Phoenix, Arizona, United States