Surgical Treatments for Postamputation Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPrometei Pain Rehabilitation Center
About this trial
This is a double-blind randomised controlled trial (RCT) which compares the effectiveness of three surgical techniques for alleviating residual limb pain (RLP), neuroma pain and phantom limb pain (PLP). The three surgical treatments are Targeted Muscles Reinnervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), and an active control (neuroma excision and muscle burying). Patients will be follow-up for 4 years.
Eligibility criteria
Qualifiers
The participant must have a major limb amputation.
The participant is ≥ 18 years old at the time of consent.
The participant must be in generally good health to undergo a surgical intervention, as per the clinical investigator's opinion.
Time since the last amputation must be over a year at the time of consent.
Disqualifiers
Neurological or other conditions that affect nerve regeneration for the nerve to be treated.
Active infection in the residual limb.
Prior RPNI or TMR surgery of the nerve to be treated (with painful neuroma) to address postamputation pain.
Mental disorders (e.g., schizophrenia, paranoia, psychosis, etc.), reluctance, or language difficulties that result in difficulty understanding the meaning of study participation.
Trial design
Treatments tested in this trial
- Targeted Muscle Reinnervation (TMR)
- Regenerative Peripheral Nerve Interface (RPNI)
- Standard neuroma treatment, neuroma excision, and muscle burying
Treatment groups
110 Participants
are divided into 3 treatment groupsSponsors and collaborators
Prometei Pain Rehabilitation Center
Lead sponsor
Vastra Gotaland Region
Collaborator
Göteborg University
Collaborator
Istituto Ortopedico Rizzoli
Collaborator
Hospital del Trabajador de Santiago
Collaborator
NHS Lothian
Collaborator
NHS Greater Clyde and Glasgow
Collaborator
NHS Grampian
Collaborator
Northwestern Memorial Hospital
Collaborator
University of Michigan
Collaborator
Massachusetts General Hospital
Collaborator
Dandenong Hospital
Collaborator
University of Alberta
Collaborator
Source ClinicalTrials.gov