Using Regenerative Peripheral Nerve Interfaces to treat painful neuromas after hand or finger amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of Regenerative Peripheral Nerve Interfaces (RPNI) surgery in alleviating neuroma pain in patients who have undergone digit or hand amputations. Participants will be assessed using validated patient-reported outcomes and will undergo a thorough evaluation of their pain management and functional capabilities before and after the surgery. The study will compare the outcomes of RPNI surgery with standard care practices to determine the potential benefits of this innovative approach.

Why it matters

Who can join: the full rules

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

Where it's running

• The Curtis National Hand Center at Medstar Union Memorial Hospital
  Baltimore, Maryland, United States Recruiting
• University of Michigan Plastic Surgery
  Ann Arbor, Michigan, United States Not yet recruiting

Study contacts

• Principal investigator: Aviram M Giladi, MS, MD — Medstar Union Memorial Hospital
• Study coordinator: Isaac C Fleming
• Email: ike.c.fleming@medstar.net
• Phone: 410-554-2486

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.