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

November 28, 2023 updated by: Travis Boyd, University of Texas Southwestern Medical Center

Prophylactic Treatment of Neuroma and Phantom Limb Pain With Targeted Muscle Reinnervation (TMR) and Regenerative Peripheral Interface (RPNI) at the Time of Major Limb Amputation: A Randomized Control Trial

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
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
Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site of amputation.
Experimental: Targeted Muscle Re-innervation
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
Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.
Experimental: Regenerative Peripheral Nerve Interface
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
Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Phantom Limb Pain
Time Frame: Specifically at the time point 1 year after their primary incisions have healed.
The primary outcome measure of the study will the incidence of phantom limb pain in each group over the course of the recovery period.
Specifically at the time point 1 year after their primary incisions have healed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity score as measured PROMIS (Patient Reported Outcomes Measurement Information System) score
Time Frame: Until 2 years after incisions have healed.
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).
Until 2 years after incisions have healed.
Pain interference score as measured by PROMIS (Patient Reported Outcomes Measurement information System) questionnaire
Time Frame: Until 2 years after incisions have healed.
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).
Until 2 years after incisions have healed.
Pain behavior measured by PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire
Time Frame: Until 2 years after incisions have healed.
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.
Until 2 years after incisions have healed.
Narcotic medical use post-operatively as measured by MME (Morphine Milligram Equivalent) Score
Time Frame: Until 2 years after incisions have healed.
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.
Until 2 years after incisions have healed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Study Director: Deborah Noble, UT Southwestern Department of Plastic Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

March 28, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

December 5, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU-2021-0348

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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