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

NCT06923566 | Completed DMC

• 1 other identifier: FMASU MD 145/2021
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Targeted Muscle Reinervation; Digital Amputation; Neuroma

Keywords

Targeted muscle reinnervation; neuroma; amputation

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (2)

• operative time

  intraoperative

• Rate of infection

  up to 30 days postoperative

Study Arms (1)

targeted muscle reinervation post digit amputation group

EXPERIMENTAL

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

Interventions

Targeted muscle reinnervation PROCEDURE

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

targeted muscle reinervation post digit amputation group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Faculty of medicine

Al ‘Abbāsīyah, Cairo Governorate, 11655, Egypt

Location

MeSH Terms

Conditions

Neuroma

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Ayman Ibrahim Fathy Aly Howeidy, Professor

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 11, 2025
• Study Start: August 20, 2021
• Primary Completion: July 30, 2023
• Study Completion: September 2, 2023
• Last Updated: April 11, 2025

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)