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

NCT05344261 | Withdrawn

• 1 other identifier: STU-2021-0348
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amputation; Neuroma Amputation; Phantom Limb Pain; Residual Limbs

Keywords

Targeted Muscle Re-innervation; Regenerative Peripheral Nerve Interface; TMR; RPNI

Outcome Measures

Primary Outcomes (1)

• 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.

  Specifically at the time point 1 year after their primary incisions have healed.

Secondary Outcomes (4)

• Pain intensity score as measured PROMIS (Patient Reported Outcomes Measurement Information System) score

  Until 2 years after incisions have healed.

• Pain interference score as measured by PROMIS (Patient Reported Outcomes Measurement information System) questionnaire

  Until 2 years after incisions have healed.

• Pain behavior measured by PROMIS (Patient Reported Outcomes Measurement Information System) questionnaire

  Until 2 years after incisions have healed.

• Narcotic medical use post-operatively as measured by MME (Morphine Milligram Equivalent) Score

  Until 2 years after incisions have healed.

Study Arms (3)

Control Arm

ACTIVE COMPARATOR

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

Targeted Muscle Re-innervation

EXPERIMENTAL

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

Regenerative Peripheral Nerve Interface

EXPERIMENTAL

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

Interventions

Targeted Muscle Re-innervation PROCEDURE

Targeted Muscle Re-innervation involves re-routing transected nerve ends to functional motor nerves proximal to the site of amputation.

Targeted Muscle Re-innervation

Regenerative Peripheral Nerve Interface PROCEDURE

Regenerative Peripheral Nerve Interface involves placing transected nerve ends in harvested muscle grafts.

Regenerative Peripheral Nerve Interface

Standard Post-Amputation Surgical Care PROCEDURE

Standard post-amputation surgical care involves placing transected nerve ends into muscle/soft tissue proximal to the site of amputation.

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Related Publications (7)

• 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.

  PMID: 18295618 BACKGROUND

• 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.

  PMID: 30371518 BACKGROUND

• 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.

  PMID: 30634038 BACKGROUND

• 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.

  PMID: 30534497 BACKGROUND

• 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.

  PMID: 31461024 BACKGROUND

• 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.

  PMID: 32115057 BACKGROUND

• 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.

  PMID: 28579692 BACKGROUND

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Deborah Noble

  UT Southwestern Department of Plastic Surgery

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSISTANT PROFESSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 25, 2022
• Study Start: March 1, 2023
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share