An interventional study of Targeted muscle reinnervation in Targeted Muscle Reinervation, Digital Amputation and Neuroma, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-11.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
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
71 studies on the registry are indexed under Neuroma; 9 are open to participants now.
This study's enrollment of 17 is below the median of 32 across 50 interventional studies indexed under Neuroma.
Browse Neuroma studies →Ain Shams University is the lead sponsor of 1,932 studies on the registry; 433 are open to participants now.
Of its 33 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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
Neuroma incidence
Neuroma incidence post TMR operation is recorded via Tinel's sign
Time frame: through study completion, an average of 1 year
Neuroma recurrence
Neuroma recurrence in cases of 2ry TMR cases
Time frame: 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
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
Pain medication usage type
pain medication usage type recorded
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
pain medication usage frequency recorded
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 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
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
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.
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
operative time
measuring the operative time
Time frame: intraoperative
Rate of infection
surgical site infections were recorded
Time frame: up to 30 days postoperative
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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