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Recruiting NCT05008185

Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation

— Observational Neuroma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Regenerative Peripheral Nerve Interface (RPNI) surgery, Traction Neurectomy.
Who it may be relevant to
Registry conditions: Neuroma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"

Overview

This study is being done to demonstrate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in treating symptomatic neuromas of the hand and digits following amputation compared to standard of care using a Prospective, Observational Trial

Detailed description

This will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after RPNI surgery compared to standard of care by utilizing multiple established and validated patient-reported outcomes measures, carefully tracking pre- and post-operative pain regimens, and performing functional and physiologic tests.

Interventions

  • Procedure Regenerative Peripheral Nerve Interface (RPNI) surgery
    Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
  • Procedure Traction Neurectomy
    Surgeons will perform neuroma resection and traction neurectomy,

Primary outcome measures

  • Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI) [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
  • Short-form McGill Pain Questionnaire (SF-MPQ-2) [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
  • PROMIS Global Health (GH) v1.2 [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
  • Patient Health Questionnaire (PHQ-9), [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
  • Generalized Anxiety Disorder measure (GAD-7), [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
  • PC-PTSD-5 [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
Secondary outcome measures (12)
  • PROMIS UpperExtremity (UE) [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
  • Brief Michigan Hand Outcomes Questionnaire (bMHQ) [Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months]
  • Grip Strength [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Pinch Strength -Key and Three-point [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Range of Motion [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Fine Motor Function - 9-Hole Peg Test (9HPT) [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • FunctionalTask Testing - Lifting boxes [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Functional Task Testing - Carrying Boxes [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Functional Task Testing - Push/Pull sled [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Functional Task Testing - Hammer [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Functional Task Testing - Vice Grip [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]
  • Functional Task Testing - Gear Shifting [Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months]

Eligibility criteria

Inclusion criteria

  • 18 years or older
  • History of unilateral digit, multiple digit, or partial hand amputation
  • Discrete neuroma pain on clinical exam
  • Following standard of care (SOC), confirmation through a local block and/or ultrasound imaging will be performed if indicated
  • Must be seen by a hand therapist for at least 6-week trial of desensitization therapy

Exclusion criteria

  • Patients with previous surgical treatment for symptomatic neuromas of the digits or hand
  • Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss
  • women pregnant at time of enrollment
  • prisoners
  • adults who are unable to consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-only

Study locations

United States · 2 centers
  • The Curtis National Hand Center at Medstar Union Memorial Hospital — Baltimore
  • University of Michigan Plastic Surgery — Ann Arbor

Publications

  • Woo SL, Kung TA, Brown DL, Leonard JA, Kelly BM, Cederna PS. Regenerative Peripheral Nerve Interfaces for the Treatment of Postamputation Neuroma Pain: A Pilot Study. Plast Reconstr Surg Glob Open. 2016 Dec 27;4(12):e1038. doi: 10.1097/GOX.0000000000001038. eCollection 2016 Dec. PMID 28293490
  • Urbanchek MG, Kung TA, Frost CM, Martin DC, Larkin LM, Wollstein A, Cederna PS. Development of a Regenerative Peripheral Nerve Interface for Control of a Neuroprosthetic Limb. Biomed Res Int. 2016;2016:5726730. doi: 10.1155/2016/5726730. Epub 2016 May 17. PMID 27294122
  • 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
  • Kemp SW, Cederna PS, Midha R. Comparative outcome measures in peripheral regeneration studies. Exp Neurol. 2017 Jan;287(Pt 3):348-357. doi: 10.1016/j.expneurol.2016.04.011. Epub 2016 Apr 17. PMID 27094121
  • Ursu DC, Urbanchek MG, Nedic A, Cederna PS, Gillespie RB. In vivo characterization of regenerative peripheral nerve interface function. J Neural Eng. 2016 Apr;13(2):026012. doi: 10.1088/1741-2560/13/2/026012. Epub 2016 Feb 9. PMID 26859115
  • Giladi AM, McGlinn EP, Shauver MJ, Voice TP, Chung KC. Measuring outcomes and determining long-term disability after revision amputation for treatment of traumatic finger and thumb amputation injuries. Plast Reconstr Surg. 2014 Nov;134(5):746e-755e. doi: 10.1097/PRS.0000000000000591. PMID 25347649
  • Langhals NB, Woo SL, Moon JD, Larson JV, Leach MK, Cederna PS, Urbanchek MG. Electrically stimulated signals from a long-term Regenerative Peripheral Nerve Interface. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:1989-92. doi: 10.1109/EMBC.2014.6944004. PMID 25570372
  • Frost CM, Cederna PS, Martin DC, Shim BS, Urbanchek MG. Decellular biological scaffold polymerized with PEDOT for improving peripheral nerve interface charge transfer. Annu Int Conf IEEE Eng Med Biol Soc. 2014;2014:422-5. doi: 10.1109/EMBC.2014.6943618. PMID 25569986

Identifiers

NCT: NCT05008185 · Pro00049513

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗