Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain
Amputation, Neuroma Amputation, Phantom Limb Pain
About this trial
This is an interventional treatment trial for Amputation focused on measuring Targeted Muscle Re-innervation, Regenerative Peripheral Nerve Interface, TMR, RPNI
Eligibility Criteria
Inclusion Criteria:
- Patients ≥18 years old
- Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) as a primary or secondary sequela of trauma.
- Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for primary or secondary sequelae of malignancy.
- Secondary sequalae include but is not limited to metastatic disease and osteolytic disease.
- Patients scheduled for amputation of upper or lower extremity (including digit, ray, and hand) for vasculitic diseases.
Exclusion Criteria:
- Patients less than 18 years old
- Patients with cognitive impairment
- Patients who are imprisoned at the time of randomization
- Patients currently enrolled in other studies relating to neuropathic pain
- Patients actively undergoing radiation therapy
- Patients with existing neuroma or underwent prior neuroma surgery
- Patients with amputations scheduled congenital reasons
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Control Arm
Targeted Muscle Re-innervation
Regenerative Peripheral Nerve Interface
Standard Post-Amputation Surgical Care: Briefly, the transected nerves will be blindly tucked into surrounding bulky soft tissue to protect the nerve ends before the wound is closed.
Briefly, each transected nerve is identified after amputation using 6-0 Prolene suture and is dissected proximally for length. With minimal dissection, 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 tagged amputated nerve.
Briefly, a muscle graft (usually from the amputated limb) is wrapped around the clean ends of the transected nerve(s).