Prevention of PostAmputation Pain With Targeted Muscle Reinnervation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLeiden University Medical Center

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

203 Participants
are divided into 2 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