Targeted Muscle Reinnervation in the Hand for the Managment of Symptomatic Neuroma Following Digit and Hand Amputations, A Prospective Case Series
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Pain character
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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
Intervention: Targeted muscle reinnervation (Procedure)
Outcomes
Primary Outcomes
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
Neuroma incidence
Time Frame: through study completion, an average of 1 year
Neuroma incidence post TMR operation is recorded via Tinel's sign
Neuroma recurrence
Time Frame: through study completion, an average of 1 year
Neuroma recurrence in cases of 2ry TMR cases
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
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
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
Secondary Outcomes
- Rate of infection(up to 30 days postoperative)
- operative time(intraoperative)