Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
Prevention of PostAmputation Pain With Targeted Muscle Reinnervation: A National, Multicenter, Randomized, Sham-controlled Superiority Trial, Comparing Standard Neurectomy With Targeted Muscle Reinnervation in Amputations of the Lower Extremities
Leiden University Medical Center
203 participants
Dec 31, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this study is to compare postamputation pain (phantom limb pain and residual limb pain) one year postoperatively in patients who received a lower extremity amputation (LEA) with standard nerve handling (neurectomy) versus those who received Targeted Muscle Reinnervation (TMR). Patients between 18 and 75 years old, scheduled for an LEA (transfemoral to transtibial) as a primary or secondary sequela of vascular disease, are randomized into standard neurectomy or TMR. TMR is a frequently studied surgical technique and prevents neuroma formation by rerouting a cut mixed nerve end to a functional motor nerve. The investigators hypothesize that TMR during amputation surgery will significant improve PostAmputation Pain (PAP), quality of life, participation in family life and society, and reduction of health-related costs. Participants will be asked to complete multiple online questionnaires postoperatively regarding these outcomes at five evaluation moments (at 2 weeks, and at 3, 6, 9, and 12 months).
Eligibility
Inclusion Criteria2
- Patients aged between 18 and 75 years old.
- Scheduled for a transtibial, through-knee, or transfemoral amputation as a primary or secondary sequela of vascular disease.
Exclusion Criteria7
- Insensate limbs at the level of amputation.
- Complex Regional Pain Syndrome.
- Existing neuroma or prior neuroma surgery in the affected limb.
- Undergoing radiotherapy on the affected limb.
- Cognitive impairment, or delirium at the time of consent.
- Patients who are unfit for general anesthesia.
- No nerve surgeon trained in the TMR procedure is available
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Interventions
In short: each transected nerve is identified after amputation and is dissected proximally for length. A nerve stimulator is used to identify functional motor nerve branches. Near the point where the motor branch enters the muscle, the motor nerve branch is transected and an end-to-end coaptation is performed with a nearby amputated nerve.
During the amputation a standard neurectomy will be performed based on the surgeons preference. Standard neurectomy will include cutting of the nerve, with or without traction, with or without coagulation, and with or without infiltration with a local anesthetic (i.e., ropivacaine) or phenol. Ligation of the nerve will not be allowed.
Locations(7)
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NCT06719245