Prevention of postamputation pain with targeted muscle reinnervation (PreventPAP trial): protocol for a national, multicentre, randomised, sham-controlled trial.

introductionIn the Netherlands, approximately 2200 major amputations of the lower extremities are performed each year, the majority in vascular patients. Around 61% of these patients will develop postamputation pain (PAP). PAP is a severe, lifelong, disabling condition profoundly affecting quality of life. During amputations, the common practice is to cut the nerves without employing nerve-surgical techniques to prevent chronic pain due to neuroma formation. In recent years, targeted muscle reinnervation (TMR) has been the most frequently studied technique for treating PAP, inhibiting neuroma formation by rerouting the cut mixed nerve to a functional motor nerve. We hypothesise that a primary TMR procedure during major lower limb amputations will result in a lower prevalence of PAP. METHODS AND ANALYSIS: We propose a national, multicentre, randomised, sham-controlled trial comparing TMR with traction neurectomy in major amputations of the lower extremities in patients with vascular disease. 203 patients will be recruited with an indication for a transfemoral to transtibial amputation as a primary or secondary sequela of vascular disease. The subjects are randomly assigned to the TMR group or the traction neurectomy group. PAP will be evaluated 1 year postoperatively as the primary endpoint. Secondary outcomes include quality of life, mobility, neuropathic pain, hospital anxiety and depression, cost-effectiveness and complications. ETHICS AND DISSEMINATION: This study has been reviewed and approved by the local ethical review body, 'The Medical Ethics Committee Leiden The Hague Delft', under the reference: P24.073 on 28 November 2024. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT06719245. Dutch trial registry: NL87196.058.24.