Skip to main content
OpenTrials
Completed

NCT Number: NCT06923566

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Targeted Muscle Reinervation Digital Amputation Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nerve Sheath Neoplasms Neuroma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University Faculty of medicine

Al ‘Abbāsīyah, Cairo Governorate, 11655, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Neuroma incidence

    Time frame: through study completion, an average of 1 year

    Neuroma incidence post TMR operation is recorded via Tinel's sign

  2. Neuroma recurrence

    Time frame: through study completion, an average of 1 year

    Neuroma recurrence in cases of 2ry TMR cases

  3. Pain intensity

    Time frame: will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study

    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

  4. Pain medication usage type

    Time frame: 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 type recorded

  5. Pain medication usage frequency

    Time frame: 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 recorded

  6. Pain character

    Time frame: will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study

    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

  7. Pain character

    Time frame: will be taken at intervals over time (1 month, 3 months,6 months, 9 months,1 year until the conclusion of the study

    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.

Secondary outcomes

  1. operative time

    Time frame: intraoperative

    measuring the operative time

  2. Rate of infection

    Time frame: up to 30 days postoperative

    surgical site infections were recorded

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.