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

Primary Purpose

Amputation, Neuroma Amputation, Phantom Limb Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Targeted Muscle Re-innervation
Regenerative Peripheral Nerve Interface
Standard Post-Amputation Surgical Care
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Control Arm

    Targeted Muscle Re-innervation

    Regenerative Peripheral Nerve Interface

    Arm 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.

    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).

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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).
    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).
    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.
    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.

    Full Information

    First Posted
    March 28, 2022
    Last Updated
    February 27, 2023
    Sponsor
    University of Texas Southwestern Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05344261
    Brief Title
    Effect of Prophylactic TMR and RPNI on Neuroma and Phantom Limb Pain
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    March 1, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2024 (Anticipated)
    Study Completion Date
    December 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Amputation, Neuroma Amputation, Phantom Limb Pain, Residual Limbs
    Keywords
    Targeted Muscle Re-innervation, Regenerative Peripheral Nerve Interface, TMR, RPNI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Arm
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Targeted Muscle Re-innervation
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Regenerative Peripheral Nerve Interface
    Arm Type
    Experimental
    Arm Description
    Briefly, a muscle graft (usually from the amputated limb) is wrapped around the clean ends of the transected nerve(s).
    Intervention Type
    Procedure
    Intervention Name(s)
    Targeted Muscle Re-innervation
    Intervention Description
    Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.
    Intervention Type
    Procedure
    Intervention Name(s)
    Regenerative Peripheral Nerve Interface
    Intervention Description
    Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.
    Intervention Type
    Procedure
    Intervention Name(s)
    Standard Post-Amputation Surgical Care
    Intervention Description
    Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site of amputation.
    Primary Outcome Measure Information:
    Title
    Incidence of Phantom Limb Pain
    Description
    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.
    Secondary Outcome Measure Information:
    Title
    Pain intensity score as measured PROMIS (Patient Reported Outcomes Measurement Information System) score
    Description
    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.
    Title
    Pain interference score as measured by PROMIS (Patient Reported Outcomes Measurement information System) questionnaire
    Description
    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.
    Title
    Pain behavior measured by PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire
    Description
    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.
    Title
    Narcotic medical use post-operatively as measured by MME (Morphine Milligram Equivalent) Score
    Description
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Muhammad H Harirah, MD
    Phone
    (214) 645-2353
    Email
    Muhammad.Harirah@UTSouthwestern.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Travis G Boyd, MD
    Phone
    (214) 645-2353
    Email
    Travis.Boyd@UTSouthwestern.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Deborah Noble
    Organizational Affiliation
    UT Southwestern Department of Plastic Surgery
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    18295618
    Citation
    Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
    Results Reference
    background
    PubMed Identifier
    30371518
    Citation
    Dumanian GA, Potter BK, Mioton LM, Ko JH, Cheesborough JE, Souza JM, Ertl WJ, Tintle SM, Nanos GP, Valerio IL, Kuiken TA, Apkarian AV, Porter K, Jordan SW. Targeted Muscle Reinnervation Treats Neuroma and Phantom Pain in Major Limb Amputees: A Randomized Clinical Trial. Ann Surg. 2019 Aug;270(2):238-246. doi: 10.1097/SLA.0000000000003088.
    Results Reference
    background
    PubMed Identifier
    30634038
    Citation
    Valerio IL, Dumanian GA, Jordan SW, Mioton LM, Bowen JB, West JM, Porter K, Ko JH, Souza JM, Potter BK. Preemptive Treatment of Phantom and Residual Limb Pain with Targeted Muscle Reinnervation at the Time of Major Limb Amputation. J Am Coll Surg. 2019 Mar;228(3):217-226. doi: 10.1016/j.jamcollsurg.2018.12.015. Epub 2019 Jan 8.
    Results Reference
    background
    PubMed Identifier
    30534497
    Citation
    Eberlin KR, Ducic I. Surgical Algorithm for Neuroma Management: A Changing Treatment Paradigm. Plast Reconstr Surg Glob Open. 2018 Oct 16;6(10):e1952. doi: 10.1097/GOX.0000000000001952. eCollection 2018 Oct.
    Results Reference
    background
    PubMed Identifier
    31461024
    Citation
    Kubiak CA, Kemp SWP, Cederna PS, Kung TA. Prophylactic Regenerative Peripheral Nerve Interfaces to Prevent Postamputation Pain. Plast Reconstr Surg. 2019 Sep;144(3):421e-430e. doi: 10.1097/PRS.0000000000005922.
    Results Reference
    background
    PubMed Identifier
    32115057
    Citation
    Santosa KB, Oliver JD, Cederna PS, Kung TA. Regenerative Peripheral Nerve Interfaces for Prevention and Management of Neuromas. Clin Plast Surg. 2020 Apr;47(2):311-321. doi: 10.1016/j.cps.2020.01.004. Epub 2020 Feb 1.
    Results Reference
    background
    PubMed Identifier
    28579692
    Citation
    Kuiken TA, Barlow AK, Hargrove L, Dumanian GA. Targeted Muscle Reinnervation for the Upper and Lower Extremity. Tech Orthop. 2017 Jun;32(2):109-116. doi: 10.1097/BTO.0000000000000194.
    Results Reference
    background

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

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