Clinical trial · Observational
Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation
Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"
NCT05008185CI-TRIAL-00083119recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neuroma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Regenerative Peripheral Nerve Interface (RPNI) surgery | Procedure | — | UNRESOLVED |
| Traction Neurectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Regenerative Peripheral Nerve Interface
- description
- symptomatic neuroma is excised, and the end of the peripheral nerve is implanted into a small denervated free muscle graft harvested from the patient
- interventionNames
- Procedure: Regenerative Peripheral Nerve Interface (RPNI) surgery
- label
- Traction Neurectomy
- description
- simple excision and traction neurectomy
- interventionNames
- Procedure: Traction Neurectomy
Primary outcomes (6)
- measure
- Patient-Reported Outcomes Measurement Information System - Pain Interference (PROMIS-PI)
- timeFrame
- Assessing change from Baseline to 1 week, 1 month, 3 months and 6 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (18)
- BACKGROUNDWoo 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
- BACKGROUNDUrbanchek 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
- BACKGROUNDSantosa 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
- BACKGROUNDKemp 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
- BACKGROUNDUrsu 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
- BACKGROUNDGiladi 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
- BACKGROUNDLanghals 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.