Targeted Muscle Reinnervation (TMR) Versus Regenerative Peripheral Nerve Interfaces (RPNI) Versus the Combined Technique of TMR-RPNI to Reduce Chronic and Phantom Limb Pain in Oncologic Amputees: A Randomized Control Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This clinical trial evaluates two surgical techniques (targeted muscle re-innervation \[TMR\] and regenerative peripheral nerve interfaces \[RPNI\]) alone and in combination for the alleviation of chronic residual limb and phantom limb pain in cancer patients who have had an amputation. Chronic residual limb pain and phantom limb pain are debilitating outcomes of traumatic and oncologic amputation. Emerging microsurgical treatments for post-amputation pain are very promising. TMR and RPNI are both approved surgical techniques that involve connecting cut nerves to parts of the muscle as a way to heal and protect the nerves. This trial evaluates these techniques alone and in combination for the treatment of residual and phantom limb pain in cancer patients who have received an amputation.

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

• Patients greater than or equal to 18 years of age who are receiving an amputation for oncologic reasons

• Patients with available mixed major nerves and donor motor nerves in the amputation stump or reconstructive tissue

• Patients able to complete informed consent

Locations
United States
Texas
M D Anderson Cancer Center
RECRUITING
Houston
Time Frame
Start Date: 2020-08-10
Estimated Completion Date: 2027-02-02
Participants
Target number of participants: 45
Treatments
Active_comparator: Arm 1 (targeted muscle reinnervation)
Patients undergo TMR procedure.
Active_comparator: Arm 2 (regenerative peripheral nerve interface)
Patients undergo RPNI procedure.
Experimental: Arm 3 (TMI + RPNI)
Patients undergo TMR in combination with RPNI.
Related Therapeutic Areas
Sponsors
Leads: M.D. Anderson Cancer Center

This content was sourced from clinicaltrials.gov