Preventing pain after lower limb amputation using targeted muscle reinnervation
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
NA · Leiden University Medical Center · NCT06719245
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 203 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Locations | 7 sites (Amsterdam, North Holland and 6 other locations) |
| Trial ID | NCT06719245 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 scheduled for a lower extremity amputation due to vascular disease.
Not a fit: Patients with amputations due to trauma, neoplasms, or those with existing neuromas may not benefit from this study.
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 performed: Previous studies have shown promising results for TMR in preventing neuroma formation, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Amsterdam, North Holland and 6 other locations
- Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (NOT_YET_RECRUITING)
- Isala Zwolle — Zwolle, Overijssel, Netherlands (NOT_YET_RECRUITING)
- Leiden University Medical Center — Leiden, South Holland, Netherlands (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)
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Amputation, Surgical, Phantom Limb Pain, Neuroma Amputation, Surgery, TMR, Amputation, Phantom pain, Neuroma