Digital Amputation, Neuroma, Targeted Muscle Reinervation
Conditions
Keywords
Targeted muscle reinnervation, neuroma, amputation
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
Interventions
PROCEDURETargeted 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
Sponsors
Ain Shams University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain character | 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 |
| Pain medication usage type | 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 | 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 |
| Neuroma incidence | through study completion, an average of 1 year | Neuroma incidence post TMR operation is recorded via Tinel's sign |
| Neuroma recurrence | through study completion, an average of 1 year | Neuroma recurrence in cases of 2ry TMR cases |
| Pain intensity | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of infection | up to 30 days postoperative | surgical site infections were recorded |
| operative time | intraoperative | measuring the operative time |
Countries
Egypt
Outcome results
None listed