An interventional study of Targeted Muscle Re-innervation and Regenerative Peripheral Nerve Interface in Amputation, Neuroma Amputation and Phantom Limb Pain, sponsored by University of Texas Southwestern Medical Center. Withdrawn. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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.
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.
155 studies on the registry are indexed under Phantom Limb; 38 are open to participants now.
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Exclusion Criteria:
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.
Procedure: Standard Post-Amputation Surgical Care
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.
Procedure: Targeted Muscle Re-innervation
Briefly, a muscle graft (usually from the amputated limb) is wrapped around the clean ends of the transected nerve(s).
Procedure: Regenerative Peripheral Nerve Interface
Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.
Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.
Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site of amputation.
Incidence of Phantom Limb Pain
The primary outcome measure of the study will the incidence of phantom limb pain in each group over the course of the recovery period.
Time frame: Specifically at the time point 1 year after their primary incisions have healed.
Pain intensity score as measured PROMIS (Patient Reported Outcomes Measurement Information System) score
Pain intensity score is measured bv PROMIS (Patient Reported Outcomes Measurement Information System) Scores via patient questionnaires administered at follow-up visits. Possible scores range from 1-5 where higher scores indicate worse outcome (pain severity).
Time frame: Until 2 years after incisions have healed.
Pain interference score as measured by PROMIS (Patient Reported Outcomes Measurement information System) questionnaire
Pain interference score as measured by PROMIS (Patient Reported Outcomes Measurement information System) scores via patient questionnaires administered at follow-up visits. Possible scores range from 1-5, where higher scores indicate worse outcome (pain interference).
Time frame: Until 2 years after incisions have healed.
Pain behavior measured by PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire
Pain behavior score measured by PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire that pertains to subject social health. Raw summed score from 8 to 40, where 40 represents severely maladaptive pain behavior.
Time frame: Until 2 years after incisions have healed.
Narcotic medical use post-operatively as measured by MME (Morphine Milligram Equivalent) Score
Narcotic medical use post-operatively as measured by MME (Morphine Milligram Equivalent) Score This is a tool to condense and standardize the patient's narcotic pain regimen.
Time frame: Until 2 years after incisions have healed.
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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