Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

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

NCT ID: NCT05008185Sponsor: Medstar Health Research InstituteLast updated: 2024-11-29

Summary

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.

Arms & interventions

  • ProcedureRegenerative 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

  • ProcedureTraction Neurectomy

    Surgeons will perform neuroma resection and traction neurectomy,

Outcome measures

Primary

  • Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)

    PROMIS Pain Interference (PROMIS-PI) scale measures the extent to which pain hinders an individual's engagement with physical, mental, cognitive, emotional, recreational, and social activities over the past 7 days answering each questions with a response of not at all, a little bit, somewhat, quite a bit, and very much with not at all being the best and very much the worst.

    Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

  • Short-form McGill Pain Questionnaire (SF-MPQ-2)

    theShort-form McGill Pain Questionnaire (SF-MPQ-2) measures 24 different qualities of pain and related symptoms using the intensity of pain and related symptoms felt during the past week on 0 to 10 scale, with 0 being no pain and 10 being the worst pain .

    Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

  • PROMIS Global Health (GH) v1.2

    The Global Health Questionnaire contains 10 questions (7 general and 3 about the last 7 days). First 7 questions use a scale of excellent, very good, good, fair, and poor, poor being the worst with excellent being the best. The other three questions use different scales such as; never rarely, sometimes, often or always with never being the best and always being the worst; as well as none, mild, moderate, severe, very severe with none being the best and very severe being the worst; finally pain rating numbered 0-10 with 0 being no pain and 10 being the worst pain imaginable.

    Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

  • Patient Health Questionnaire (PHQ-9),

    The PHQ-9 form is a brief, self-administered questionnaire that assesses depression symptoms over the last 2 weeks consisting of 10 questions. 9 will be answered on a scale of 0-3 with 0 being the best and 3 bing the worst. The last question will use a response of not difficult at all, somewhat difficult, very difficult, and extremely difficult with not difficult at all being the best and extremely difficult being the worst.

    Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

  • Generalized Anxiety Disorder measure (GAD-7),

    Generalized Anxiety Disorder measure (GAD-7) is a screening tool and severity measure for generalised anxiety disorder (GAD) over the past 2 weeks consisting of 7 questions answered on a scale of 0-3 with 0 being the best and 3 being the worst.

    Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

  • PC-PTSD-5

    The Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) is a 5-item screening tool with 'Yes/No" answers designed to identify individuals with probable PTSD. Yes" answers represent the worst and "no" represents the best.

    Time frame: Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months

Secondary

  • 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

  • Functional Task Testing - Weapon Recoil

    Time frame: Assessing change from Baseline to 1 month, 3 months and 6 months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: Yes
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

Study locations (2)

The Curtis National Hand Center at Medstar Union Memorial Hospital

Baltimore, Maryland, 21218

Recruiting
Ike Fleming · Contact
410-554-2486ike.c.fleming@medstar.net
Alessandra Butanis · Contact
410-554-2123alessandra.l.butanis@medstar.net
Aviram M Gildai, MD, MS · Principal Investigator

University of Michigan Plastic Surgery

Ann Arbor, Michigan, 48109

Not Yet Recruiting
Jenni Hammill, M.P.H · Contact
570-559-7912jenberry@med.umich.edu
Theodore A Kung, MD · Principal Investigator

References

  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • 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.(PubMed)
  • Woo SL, Urbanchek MG, Cederna PS, Langhals NB. Revisiting nonvascularized partial muscle grafts: a novel use for prosthetic control. Plast Reconstr Surg. 2014 Aug;134(2):344e-346e. doi: 10.1097/PRS.0000000000000317. No abstract available.(PubMed)
  • Kung TA, Langhals NB, Martin DC, Johnson PJ, Cederna PS, Urbanchek MG. Regenerative peripheral nerve interface viability and signal transduction with an implanted electrode. Plast Reconstr Surg. 2014 Jun;133(6):1380-1394. doi: 10.1097/PRS.0000000000000168.(PubMed)
  • Kung TA, Bueno RA, Alkhalefah GK, Langhals NB, Urbanchek MG, Cederna PS. Innovations in prosthetic interfaces for the upper extremity. Plast Reconstr Surg. 2013 Dec;132(6):1515-1523. doi: 10.1097/PRS.0b013e3182a97e5f.(PubMed)
  • Hooper RC, Cederna PS, Brown DL, Haase SC, Waljee JF, Egeland BM, Kelley BP, Kung TA. Regenerative Peripheral Nerve Interfaces for the Management of Symptomatic Hand and Digital Neuromas. Plast Reconstr Surg Glob Open. 2020 Jun 4;8(6):e2792. doi: 10.1097/GOX.0000000000002792. eCollection 2020 Jun.(PubMed)
  • Svientek SR, Ursu DC, Cederna PS, Kemp SWP. Fabrication of the Composite Regenerative Peripheral Nerve Interface (C-RPNI) in the Adult Rat. J Vis Exp. 2020 Feb 25;(156):10.3791/60841. doi: 10.3791/60841.(PubMed)
  • Vu PP, Vaskov AK, Irwin ZT, Henning PT, Lueders DR, Laidlaw AT, Davis AJ, Nu CS, Gates DH, Gillespie RB, Kemp SWP, Kung TA, Chestek CA, Cederna PS. A regenerative peripheral nerve interface allows real-time control of an artificial hand in upper limb amputees. Sci Transl Med. 2020 Mar 4;12(533):eaay2857. doi: 10.1126/scitranslmed.aay2857.(PubMed)
  • Frost CM, Ursu DC, Flattery SM, Nedic A, Hassett CA, Moon JD, Buchanan PJ, Brent Gillespie R, Kung TA, Kemp SWP, Cederna PS, Urbanchek MG. Regenerative peripheral nerve interfaces for real-time, proportional control of a Neuroprosthetic hand. J Neuroeng Rehabil. 2018 Nov 20;15(1):108. doi: 10.1186/s12984-018-0452-1.(PubMed)