Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations

Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations, A Prospective Case Series

Neuromas are a common complication after digital and hand amputations, resulting in significant pain, discomfort, and functional impairment. Various management methods are available, including surgical excision, nerve blocks, and nerve stump protectors, but these treatments may have limited success rates and potential complications. Targeted muscle reinnervation (TMR) is a promising technique that involves surgically rerouting a severed nerve into a nearby muscle, which can prevent the formation of neuromas and provide improved muscle function

Study Overview

• Status: Completed
• Conditions: Neuroma; Targeted Muscle Reinervation; Digital Amputation
• Intervention / Treatment: Procedure: Targeted muscle reinnervation

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo
    • Al Abbasiyah, Cairo, Egypt, 11655
      • Ain Shams University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Arabic or English speaking individuals
• An upper limb amputation distal to the wrist crease
• A symptomatic neuroma within the hand or digits: defined as patient-reported localized pain consistent with a clinical exam of a neuroma pain.There must be a supporting Tinel's sign on physical exam.

Exclusion Criteria:

• Cognitive impairment for better assessment of patient reported outcomes and filling questionnaires and signing consents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: targeted muscle reinervation post digit amputation group; In 1ry TMR ,after the amputation is performed by the standard method , transected nerves will be replanted micro surgically to motor entry points (MEPS)in the hand as predetermined by Daugherty et al , Motor branches in the recipient muscles could be determined by a nerve stimulator intraoperatively. In 2ry TMR , neuroma site will be explored and it will be excised ,the distal end of the transected nerve will be connected micro surgically to the nearest MEPS

Procedure: Targeted muscle reinnervation; In 1ry TMR ,after the amputation is performed by the standard method , transected nerves will be replanted micro surgically to motor entry points (MEPS)in the hand as predetermined by Daugherty et al , Motor branches in the recipient muscles could be determined by a nerve stimulator intraoperatively. In 2ry TMR , neuroma site will be explored and it will be excised ,the distal end of the transected nerve will be connected micro surgically to the nearest MEPS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuroma incidence	Neuroma incidence post TMR operation is recorded via Tinel's sign	through study completion, an average of 1 year
Neuroma recurrence	Neuroma recurrence in cases of 2ry TMR cases	through study completion, an average of 1 year
Pain intensity	measured using pain rating numerical scale commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning "no pain" and 10 meaning "the worst pain imaginable	will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
Pain medication usage type	pain medication usage type recorded	Followed up at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
Pain medication usage frequency	pain medication usage frequency recorded	Followed up at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
Pain character	Leeds Assessment of neuropathic symptoms and signs pain scale is a valuable tool designed to evaluate and categorize pain. Its primary purpose is to determine if nerve damage is the primary cause of the pain, distinguishing between neuropathic and nociceptive pain. The scale comprises seven items, divided into two sections. The first part consists of five questions related to symptoms experienced by the individual. The second part involves two clinical examination items that are typically conducted in collaboration with a healthcare provider. A score of 12 or more on this scale confirms a diagnosis of neuropathic pain to some degree. Scores below 12 are less likely to show neuropathic pain	will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study
Pain character	The McGill Pain Questionnaire is a well-known assessment tool used to quantify and understand the subjective experience of pain. It primarily consists of three major categories of word descriptors-sensory affective, and evaluative-through which patients can express and specify their pain experience. In addition to these descriptors, the questionnaire includes an intensity scale and other items to further capture the properties of the pain being experienced.	will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	measuring the operative time	intraoperative
Rate of infection	surgical site infections were recorded	up to 30 days postoperative

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Study Chair: Ayman Ibrahim Fathy Aly Howeidy, Professor, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2021
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): September 2, 2023

Study Registration Dates

• First Submitted: March 6, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 11, 2025

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: amputation; neuroma; Targeted muscle reinnervation
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Nerve Sheath Neoplasms; Neuroma
• Other Study ID Numbers: FMASU MD 145/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No