About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Targeted Muscle Reinnervation (TMR)
- Standard neurectomy
Treatment groups
Sponsors and collaborators
Leiden University Medical Center
Lead sponsor
Alrijne Hospital
Collaborator
Medical Center Haaglanden
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborator
UMC Utrecht
Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator
Erasmus Medical Center
Collaborator
Isala
Collaborator