Preventing pain after lower limb amputation using targeted muscle reinnervation
Official title: 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
Run by Leiden University Medical Center · NCT06719245 · Data updated 2026-11-12
This study is testing if a new technique called Targeted Muscle Reinnervation can help reduce pain after lower limb amputation compared to standard nerve handling.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 203 (estimated) |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 7 sites (Amsterdam, North Holland and 6 other locations) |
| Status | Recruiting |
| Started | December 31, 2024 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2028 |
| Registry record updated | September 19, 2025 |
| Trial ID | NCT06719245 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 75 scheduled for a lower extremity amputation due to vascular disease.
✕Probably not a fit
Patients with amputations due to trauma, neoplasms, or those with existing neuromas may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the occurrence of postamputation pain, including phantom limb pain and residual limb pain, in patients undergoing lower extremity amputation. Participants will be randomized to receive either standard nerve handling (neurectomy) or Targeted Muscle Reinnervation (TMR), a technique designed to prevent neuroma formation by rerouting nerves to functional motor nerves. The study will assess outcomes one year postoperatively through multiple online questionnaires, focusing on pain levels, quality of life, and societal participation. The hypothesis is that TMR will significantly reduce postamputation pain and improve overall patient outcomes.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic pain and improve the quality of life for amputation patients.
How similar studies have gone: Previous studies have shown promising results for TMR in preventing neuroma formation, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Leiden University Medical Center
Leiden, South Holland, Netherlands Recruiting -
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands Not yet recruiting -
Isala Zwolle
Zwolle, Overijssel, Netherlands Not yet recruiting -
Alrijne Zorggroep
Leiderdorp, South Holland, Netherlands Not yet recruiting -
Erasmus Medical Center
Rotterdam, South Holland, Netherlands Not yet recruiting -
Haaglanden Medisch Centrum
The Hague, South Holland, Netherlands Not yet recruiting
Show 1 more location
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University Medical Center Utrecht
Utrecht, Utrecht, Netherlands Not yet recruiting
Study contacts
- Principal investigator: Justus L Groen, MD PhD — Leiden University Medical Center
- Study coordinator: Justus L Groen, Md PhD
- Email: j.l.groen@lumc.nl
- Phone: +31715262109
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Neuropathic pain after childhood amputation
This project sees how common phantom and residual limb neuropathic pain is and how it affects children and teens who had limb amputations.
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Tracking early pain and recovery after a limb amputation
This project will look at early post‑operative pain and functional recovery in adults who had a limb amputation to see how pain changes and what factors are linked to better or worse recovery.
-
Effects of magnetic stimulation on phantom limb pain in amputees
This study tests if using magnetic stimulation can help reduce phantom limb pain in people who have had upper limb amputations.
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Evaluating a neuroprosthesis to reduce phantom limb pain and improve quality of life
This study is testing a new device to see if it can help people with phantom limb pain feel better and improve their experience with bionic limbs.
-
Neuromodulation for relieving phantom limb pain
This study is testing different ways to use electrical stimulation to help people who have had a limb amputated and are suffering from phantom limb pain feel better.
-
Treatment for phantom limb pain using visual simulation therapy
This study is testing if a new therapy using visual simulations can help amputees with phantom limb pain feel less discomfort compared to standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.