Using Regenerative Peripheral Nerve Interfaces to treat painful neuromas after hand or finger amputation
Regenerative Peripheral Nerve Interfaces to Treat Painful Digit and Hand Neuromas After Amputation: A Prospective Observational Trial"
This study is testing a new surgery called Regenerative Peripheral Nerve Interfaces to see if it can help reduce pain from nerve issues in people who have had fingers or hands amputated.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medstar Health Research Institute Academic / other |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05008185 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a history of unilateral digit or hand amputation and discrete neuroma pain.
Not a fit: Patients who have previously undergone surgical treatment for symptomatic neuromas or have other major injuries causing chronic pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve function for patients suffering from neuromas after amputation.
How similar studies have performed: While the use of RPNI is a novel approach, similar studies have shown promise in addressing neuroma pain, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Baltimore, Maryland and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.