RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-10-05
Study Completion:2025-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05008185

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years or older
  2. * History of unilateral digit, multiple digit, or partial hand amputation
  3. * Discrete neuroma pain on clinical exam
  4. * Following standard of care (SOC), confirmation through a local block and/or ultrasound imaging will be performed if indicated
  5. * Must be seen by a hand therapist for at least 6-week trial of desensitization therapy
  1. * Patients with previous surgical treatment for symptomatic neuromas of the digits or hand
  2. * Patients with other major injuries more proximal in the ipsilateral extremity that cause chronic pain or functional loss
  3. * women pregnant at time of enrollment
  4. * prisoners
  5. * adults who are unable to consent

Contacts and Locations

Study Contact

Isaac C Fleming
CONTACT
410-554-2486
ike.c.fleming@medstar.net

Principal Investigator

Aviram M Giladi, MS, MD
PRINCIPAL_INVESTIGATOR
Medstar Union Memorial Hospital

Study Locations (Sites)

The Curtis National Hand Center at Medstar Union Memorial Hospital
Baltimore, Maryland, 21218
United States
University of Michigan Plastic Surgery
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: Medstar Health Research Institute

  • Aviram M Giladi, MS, MD, PRINCIPAL_INVESTIGATOR, Medstar Union Memorial Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-05
Study Completion Date2025-08

Study Record Updates

Study Start Date2021-10-05
Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

  • Neuroma
  • Neuroma Pain
  • Finger Amputation
  • Hand Amputation

Additional Relevant MeSH Terms

  • Neuroma