NCT05008185

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"

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

This will be a prospective observational study that seeks to provide a comprehensive assessment of the outcomes after RPNI surgery compared to standard of care by utilizing multiple established and validated patient-reported outcomes measures, carefully tracking pre- and post-operative pain regimens, and performing functional and physiologic tests.

Conditions

• Neuroma

Interventions

Type	Name	Description
PROCEDURE	Regenerative Peripheral Nerve Interface (RPNI) surgery	Surgeons will perform neuroma resection and RPNI creation using a free muscle graft from the brachioradialis muscle harvested through a small separate incision
PROCEDURE	Traction Neurectomy	Surgeons will perform neuroma resection and traction neurectomy,

Timeline

• Start date: 2021-10-05
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2021-08-17
• Last updated: 2024-11-29

Locations

2 sites across 1 country: United States