{
  "abstract": "Introduction In 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",
  "authors": [
    {
      "affiliations": [
        "Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands",
        "Surgery, Leiden University Medical Center, Leiden, The Netherlands"
      ],
      "name": "Guus A H Tendijck"
    },
    {
      "affiliations": [
        "Surgery, Leiden University Medical Center, Leiden, The Netherlands"
      ],
      "name": "Jan van Schaik"
    },
    {
      "affiliations": [
        "Plastic, Reconstructive and Hand Surgery, Leiden University Medical Center, Leiden, The Netherlands"
      ],
      "name": "Robert R Dijkman"
    },
    {
      "affiliations": [
        "Anesthesiology and Pain Medicine, Leiden University Medical Center, Leiden, The Netherlands"
      ],
      "name": "Marieke Niesters"
    },
    {
      "affiliations": [
        "Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands"
      ],
      "name": "Erik W van Zwet"
    },
    {
      "affiliations": [
        "Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands"
      ],
      "name": "Wilbert B van den Hout"
    },
    {
      "affiliations": [
        "Surgery, Alrijne Zorggroep, Leiderdorp, The Netherlands"
      ],
      "name": "Arianne J Ploeg"
    },
    {
      "affiliations": [
        "Plastic, Reconstructive and Hand Surgery, Isala Hospital, Zwolle, The Netherlands"
      ],
      "name": "Willem G van Rijt"
    },
    {
      "affiliations": [
        "Neurosurgery, Medisch Centrum Haaglanden, Den Haag, The Netherlands"
      ],
      "name": "Godard C W de Ruiter"
    },
    {
      "affiliations": [
        "Plastic, Reconstructive and Hand Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands"
      ],
      "name": "J Henk Coert"
    },
    {
      "affiliations": [
        "Plastic, Reconstructive and Hand Surgery, Amsterdam University Medical Centres, Amsterdam, The Netherlands"
      ],
      "name": "Liron S Duraku"
    },
    {
      "affiliations": [
        "Plastic, Reconstructive and Hand Surgery, Erasmus MC, Rotterdam, The Netherlands"
      ],
      "name": "J Michiel Zuidam"
    },
    {
      "affiliations": [
        "Surgery, Maastricht UMC+, Maastricht, The Netherlands"
      ],
      "name": "Willemien van de Water"
    },
    {
      "affiliations": [
        "Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands",
        "Neurosurgery, Alrijne Zorggroep, Leiderdorp, The Netherlands"
      ],
      "name": "Willem Pondaag"
    },
    {
      "affiliations": [
        "Rehabilitation Medicine, Leiden University Medical Center, Leiden, The Netherlands"
      ],
      "name": "Hanneke van der Krogt"
    },
    {
      "affiliations": [
        "Neurosurgery, Leiden University Medical Center, Leiden, The Netherlands",
        "Neurosurgery, Alrijne Zorggroep, Leiderdorp, The Netherlands"
      ],
      "name": "Justus L Groen"
    },
    {
      "affiliations": [],
      "name": "PreventPAP consortium"
    }
  ],
  "title": "Prevention of postamputation pain with targeted muscle reinnervation (PreventPAP trial): protocol for a national, multicentre, randomised, sham-controlled trial",
  "uid": "343f4914-0ef0-5ec0-8eb3-1e2116c92475"
}