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Prevention of PostAmputation Pain With Targeted Muscle Reinnervation

RecruitingNAAges 18 Years - 75 YearsAllLeiden University Medical Center
NCT06719245 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 ques

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📋 Eligibility rules (as published)
Inclusion criteria * 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 criteria * 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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What it tests

  • Targeted Muscle Reinnervation (TMR)
  • Standard neurectomy
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Where

7 sites
Amsterdam University Medical Center
Amsterdam, Netherlands
Isala Zwolle
Zwolle, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Alrijne Zorggroep
Leiderdorp, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
Haaglanden Medisch Centrum
The Hague, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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