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

RECRUITINGSponsored by Medstar Health Research Institute
Actively Recruiting
SponsorMedstar Health Research Institute
Started2021-10-05
Est. completion2025-08
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations2 sites

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

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

CancerNeuroma

Locations2 sites

Maryland

1 site
The Curtis National Hand Center at Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
Ike Fleming410-554-2486ike.c.fleming@medstar.net

Michigan

1 site
University of Michigan Plastic Surgery
Ann Arbor, Michigan, 48109
Jenni Hammill, M.P.H570-559-7912jenberry@med.umich.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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