Prevention of PostAmputation Pain With Targeted Muscle Reinnervation

NARecruitingINTERVENTIONAL
Enrollment

203

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

January 1, 2028

Study Completion Date

January 1, 2028

Conditions
Amputation, SurgicalPhantom Limb PainNeuroma AmputationSurgery
Interventions
PROCEDURE

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.

PROCEDURE

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.

Trial Locations (7)

1105 AZ

NOT_YET_RECRUITING

Amsterdam University Medical Center, Amsterdam

8025 AB

NOT_YET_RECRUITING

Isala Zwolle, Zwolle

2333 ZA

RECRUITING

Leiden University Medical Center, Leiden

2353 GA

NOT_YET_RECRUITING

Alrijne Zorggroep, Leiderdorp

3015 GD

NOT_YET_RECRUITING

Erasmus Medical Center, Rotterdam

2512 VA

NOT_YET_RECRUITING

Haaglanden Medisch Centrum, The Hague

3584 CX

NOT_YET_RECRUITING

University Medical Center Utrecht, Utrecht

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Alrijne Hospital

OTHER

collaborator

Medical Center Haaglanden

OTHER

collaborator

ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

collaborator

UMC Utrecht

OTHER

collaborator

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

OTHER

collaborator

Erasmus Medical Center

OTHER

collaborator

Isala

OTHER

lead

Leiden University Medical Center

OTHER