Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain

The University of Texas System (UT)

Status: Withdrawn

Conditions: Residual Limbs; Neuroma Amputation; Amputation; Phantom Limb Pain

Treatments: Procedure: Standard Post-Amputation Surgical Care; Procedure: Targeted Muscle Re-innervation; Procedure: Regenerative Peripheral Nerve Interface

Study type: Interventional

Funder types: Other

Identifiers

NCT05344261

STU-2021-0348

Details and patient eligibility

About

The purpose of this study is to analyze the efficacy of novel interventions in post-amputation surgical care (specifically Targeted Muscle Reinnervation and Regenerative Peripheral Nerve Interface) on post-amputation pain and functional outcomes at the time of amputation. These novel interventions have been shown to be successful in treating the downstream effects of amputations (pain, phantom limb pain, neuroma pain, etc.), but has not been studied in a randomized manner at the time of amputation.

Full description

The investigators plan a randomized control trial of all eligible patients undergoing major limb amputation at Parkland Memorial Hospital. Eligible patients undergoing an amputation will be consented for all possible interventions and randomized to either receive Targeted Muscle Re-Innervation (TMR), Regenerative Peripheral Nerve Interface (RPNI), or standard post-amputation surgical care at the time of their operation. Key pre-operative data including patient sex, age, BMI, past medical history, past surgical history, medications, allergies, social history, social support systems, exposure to narcotic medication, and reason for amputation will be analyzed. Intra-operatively, patients randomized to the treatment arm will receive TMR or RPNI and the transected nerve ends addressed will be recorded. Post-operative data that will be recorded include hospital stay, complications related to the procedure, complications leading to reoperation, functional results, need for pain medication, incidence of phantom limb pain, incidence of painful neuromas, length of follow-up, and all adverse events/complications. Analyses will be conducted using data obtained from patient medical records from the Parkland Health & Hospital System.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Control Arm

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Post-Amputation Surgical Care

Targeted Muscle Re-innervation

Experimental group

Description:

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.

Treatment:

Procedure: Targeted Muscle Re-innervation

Regenerative Peripheral Nerve Interface

Experimental group

Description:

Briefly, a muscle graft (usually from the amputated limb) is wrapped around the clean ends of the transected nerve(s).

Treatment:

Procedure: Regenerative Peripheral Nerve Interface