Comparing Standard Nerve Cutting and Targeted Muscle Reinnervation to Prevent Post-Amputation Pain in Lower Limb Amputations for Vascular Disease Patients Aged 18 to 75

What this Trial Is About

Researchers are investigating postamputation pain, including phantom limb pain and residual limb pain, in patients who have undergone lower extremity amputation due to vascular disease. The study compares standard nerve handling neurectomy with Targeted Muscle Reinnervation TMR, a surgical technique aimed at preventing neuroma formation by rerouting cut nerve ends to motor nerves. This national, multicenter, randomized, sham-controlled trial aims to assess if TMR improves pain outcomes, quality of life, social participation, and reduces health-related costs. Participants aged 18 to 75 years undergoing transfemoral to transtibial amputation are randomly assigned to either standard neurectomy or TMR. Standard neurectomy involves cutting nerves with or without traction, coagulation, or local anesthetic infiltration but without nerve ligation. TMR involves identifying transected nerves, dissecting them proximally, stimulating motor nerve branches, and coapting amputated nerves end-to-end to motor branches. For upper leg amputations, an additional superficial incision is made in both groups to maintain blinding. The procedure extends surgery time by 30 to 90 minutes. Participants will complete multiple online questionnaires at five time points postoperatively 2 weeks, and 3, 6, 9, and 12 months. Researchers will measure pain intensity using numerical rating scales and patient-reported pain behavior and interference. Secondary outcomes include neuropathic pain, anxiety, depression, prosthetic rehabilitation, quality of life, and healthcare costs. The study will monitor safety, surgical complications, and overall patient burden, with minimal risk anticipated from the additional procedure and follow-up lasting one year.

Prevention of PostAmputation Pain With Targeted Muscle Reinnervation