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Prevention of PostAmputation Pain With Targeted Muscle Reinnervation
Sponsor: Leiden University Medical Center
Summary
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).
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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
203
Start Date
2024-12-31
Completion Date
2028-01-01
Last Updated
2025-09-19
Healthy Volunteers
No
Interventions
Targeted Muscle Reinnervation (TMR)
In short: each transected nerve is identified after amputation and is dissected proximally for length. A nerve stimulator is used to identify functional motor nerve branches. Near the point where the motor branch enters the muscle, the motor nerve branch is transected and an end-to-end coaptation is performed with a nearby amputated nerve.
Standard neurectomy
During the amputation a standard neurectomy will be performed based on the surgeons preference. Standard neurectomy will include cutting of the nerve, with or without traction, with or without coagulation, and with or without infiltration with a local anesthetic (i.e., ropivacaine) or phenol. Ligation of the nerve will not be allowed.
Locations (7)
Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands
Isala Zwolle
Zwolle, Overijssel, Netherlands
Leiden University Medical Center
Leiden, South Holland, Netherlands
Alrijne Zorggroep
Leiderdorp, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Haaglanden Medisch Centrum
The Hague, South Holland, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands