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

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Amsterdam University Medical Center
NOT_YET_RECRUITING
Amsterdam
Leiden University Medical Center
RECRUITING
Leiden
Alrijne Zorggroep
NOT_YET_RECRUITING
Leiderdorp
Erasmus Medical Center
NOT_YET_RECRUITING
Rotterdam
Haaglanden Medisch Centrum
NOT_YET_RECRUITING
The Hague
University Medical Center Utrecht
NOT_YET_RECRUITING
Utrecht
Isala Zwolle
NOT_YET_RECRUITING
Zwolle
Contact Information
Primary
Justus L Groen, Md PhD
j.l.groen@lumc.nl
+31715262109
Time Frame
Start Date: 2024-12-31
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 203
Treatments
Other: Standard Neurectomy (control)
Standard Neurectomy during amputation (control)
Other: Targeted Muscle Reinnervation (intervention)
Targeted Muscle Reinnervation (TMR) during amputation (intervention)
Related Therapeutic Areas
Sponsors
Collaborators: UMC Utrecht, Alrijne Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Isala, Medical Center Haaglanden, Erasmus Medical Center, ZonMw: The Netherlands Organisation for Health Research and Development
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov