Targeted Muscle Reinnervation Study (TMR)

NCT05408520 | Unknown DMC

• 1 other identifier: STUDY00000650
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Amputation

Keywords

lower extremity amputation; neuroma; phantom limb pain; nerve damage; postoperative pain amputee; reinnervation; regenerative neurotization

Outcome Measures

Primary Outcomes (2)

• Effect of TMR on neuroma

  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).

  Pre-operative through 24 months

• Effect of TMR on phantom limb pain

  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).

  Pre-operative through 24 months

Study Arms (2)

Amputation with TMR

EXPERIMENTAL

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.

Procedure: Targeted Muscle Reinnervation

Amputation without TMR (SOC)

NO INTERVENTION

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

Interventions

Targeted Muscle Reinnervation PROCEDURE

When a nerve is severed or injured, it attempts to regenerate. The TMR procedure will transfer the transected nerves to adjacent muscle nerves in efforts to encourage the nerve to regenerate in an organized fashion.

Amputation with TMR

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Joshua Hustedt: lead

Study Sites (1)

Banner - University Medical Center, Phoenix campus

Phoenix, Arizona, 85006, United States

Location

Related Publications (9)

• Bowen JB, Ruter D, Wee C, West J, Valerio IL. Targeted Muscle Reinnervation Technique in Below-Knee Amputation. Plast Reconstr Surg. 2019 Jan;143(1):309-312. doi: 10.1097/PRS.0000000000005133.

  PMID: 30589808 BACKGROUND

• Kuiken TA, Dumanian GA, Lipschutz RD, Miller LA, Stubblefield KA. The use of targeted muscle reinnervation for improved myoelectric prosthesis control in a bilateral shoulder disarticulation amputee. Prosthet Orthot Int. 2004 Dec;28(3):245-53. doi: 10.3109/03093640409167756.

  PMID: 15658637 BACKGROUND

• Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.

  PMID: 18295618 BACKGROUND

• Bowen JB, Wee CE, Kalik J, Valerio IL. Targeted Muscle Reinnervation to Improve Pain, Prosthetic Tolerance, and Bioprosthetic Outcomes in the Amputee. Adv Wound Care (New Rochelle). 2017 Aug 1;6(8):261-267. doi: 10.1089/wound.2016.0717.

  PMID: 28831329 BACKGROUND

• Souza JM, Cheesborough JE, Ko JH, Cho MS, Kuiken TA, Dumanian GA. Targeted muscle reinnervation: a novel approach to postamputation neuroma pain. Clin Orthop Relat Res. 2014 Oct;472(10):2984-90. doi: 10.1007/s11999-014-3528-7.

  PMID: 24562875 BACKGROUND

• Valerio IL, Dumanian GA, Jordan SW, Mioton LM, Bowen JB, West JM, Porter K, Ko JH, Souza JM, Potter BK. Preemptive Treatment of Phantom and Residual Limb Pain with Targeted Muscle Reinnervation at the Time of Major Limb Amputation. J Am Coll Surg. 2019 Mar;228(3):217-226. doi: 10.1016/j.jamcollsurg.2018.12.015. Epub 2019 Jan 8.

  PMID: 30634038 BACKGROUND

• Valerio I, Schulz SA, West J, Westenberg RF, Eberlin KR. Targeted Muscle Reinnervation Combined with a Vascularized Pedicled Regenerative Peripheral Nerve Interface. Plast Reconstr Surg Glob Open. 2020 Mar 25;8(3):e2689. doi: 10.1097/GOX.0000000000002689. eCollection 2020 Mar.

  PMID: 32537346 BACKGROUND

• Dumanian GA, Potter BK, Mioton LM, Ko JH, Cheesborough JE, Souza JM, Ertl WJ, Tintle SM, Nanos GP, Valerio IL, Kuiken TA, Apkarian AV, Porter K, Jordan SW. Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial. Ann Surg. 2019 Aug;270(2):238-246. doi: 10.1097/SLA.0000000000003088.

  PMID: 30371518 BACKGROUND

• Chang BL, Mondshine J, Attinger CE, Kleiber GM. Targeted Muscle Reinnervation Improves Pain and Ambulation Outcomes in Highly Comorbid Amputees. Plast Reconstr Surg. 2021 Aug 1;148(2):376-386. doi: 10.1097/PRS.0000000000008153.

  PMID: 34398088 BACKGROUND

MeSH Terms

Conditions

Neuroma; Phantom Limb

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Joshua Hustedt, MD, MHS

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Orthopedics

Model Details: A traditional amputation follows the normal standard of care, with transection of peripheral nerves. The TMR procedure will transfer the transected nerves to adjacent muscle nerves.

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 7, 2022
• Study Start: May 1, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: April 19, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)