Clinical trial · Interventional
Prevention of PostAmputation Pain With 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 questionnaires postoperatively regarding these outcomes at five evaluation moments (at 2 weeks, and at 3, 6, 9, and 12 months).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Amputation, Surgical | — | UNRESOLVED | — |
| Neuroma Amputation | — | UNRESOLVED | — |
| Phantom Limb Pain | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard neurectomy | Procedure | — | UNRESOLVED |
| Targeted Muscle Reinnervation (TMR) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard Neurectomy (control)
- description
- Standard Neurectomy during amputation (control)
- interventionNames
- Procedure: Standard neurectomy
- type
- OTHER
- label
- Targeted Muscle Reinnervation (intervention)
- description
- Targeted Muscle Reinnervation (TMR) during amputation (intervention)
- interventionNames
- Procedure: Targeted Muscle Reinnervation (TMR)
Primary outcomes (4)
- measure
- Postoperative residual limb pain
- timeFrame
- at 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (26)
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- BACKGROUNDMioton LM, Dumanian GA, Shah N, Qiu CS, Ertl WJ, Potter BK, Souza JM, Valerio IL, Ko JH, Jordan SW. Targeted Muscle Reinnervation Improves Residual Limb Pain, Phantom Limb Pain, and Limb Function: A Prospective Study of 33 Major Limb Amputees. Clin Orthop Relat Res. 2020 Sep;478(9):2161-2167. doi: 10.1097/CORR.0000000000001323. PMID 32452928
- BACKGROUNDDal-Re R, Janiaud P, Ioannidis JPA. Real-world evidence: How pragmatic are randomized controlled trials labeled as pragmatic? BMC Med. 2018 Apr 3;16(1):49. doi: 10.1186/s12916-018-1038-2. PMID 29615035
- BACKGROUNDTorrance N, Lawson KD, Afolabi E, Bennett MI, Serpell MG, Dunn KM, Smith BH. Estimating the burden of disease in chronic pain with and without neuropathic characteristics: does the choice between the EQ-5D and SF-6D matter? Pain. 2014 Oct;155(10):1996-2004. doi: 10.1016/j.pain.2014.07.001. Epub 2014 Jul 11. PMID 25020004
- BACKGROUNDParsons B, Schaefer C, Mann R, Sadosky A, Daniel S, Nalamachu S, Stacey BR, Nieshoff EC, Tuchman M, Anschel A. Economic and humanistic burden of post-trauma and post-surgical neuropathic pain among adults in the United States. J Pain Res. 2013 Jun 17;6:459-69. doi: 10.2147/JPR.S44939. Print 2013. PMID 23825931
- BACKGROUNDGroffen AJ, Klapwijk T, van Rootselaar AF, Groen JL, Tijssen MA. Genetic and phenotypic heterogeneity in sporadic and familial forms of paroxysmal dyskinesia. J Neurol. 2013 Jan;260(1):93-9. doi: 10.1007/s00415-012-6592-5. Epub 2012 Jun 30. PMID 22752065
- BACKGROUNDValerio IL, Dumanian GA, Jordan SW, Mioton LM, Bowen JB, West JM, Porter K, Ko JH, Souza JM, Potter BK. Preemptive Treatment of Phantom and Residual Limb Pain with Targeted Muscle Reinnervation at the Time of Major Limb Amputation. J Am Coll Surg. 2019 Mar;228(3):217-226. doi: 10.1016/j.jamcollsurg.2018.12.015. Epub 2019 Jan 8.