Condition: Amputation, Surgical · Phantom Limb Pain · Neuroma Amputation · Sponsor: Leiden University Medical Center
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).
This description comes directly from the study's public registry record.
Justus L Groen, Md PhD · +31715262109 · j.l.groen@lumc.nl
Always discuss trial participation with your own doctor first.
| 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 |
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Source record: clinicaltrials.gov/study/NCT06719245