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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | measuring the operative time | intraoperative |
| Rate of infection | surgical site infections were recorded | up to 30 days postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ayman Ibrahim Fathy Aly Howeidy, Professor | Ain Shams University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Faculty of medicine | Al ‘Abbāsīyah | Cairo Governorate | 11655 | Egypt |
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| ID | Term |
|---|---|
| D009463 | Neuroma |
| ID | Term |
|---|---|
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| 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 |