Digital nerve procedure for Neuroma Amputation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Neuroma Amputation+2 MoreDigital nerve procedure - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will compare three treatments for nerve pain after finger amputation: targeted muscle reinnervation (TMR), regenerative peripheral nerve interfaces (RPNI), and standard traction neurectomy (TN).

Eligible Conditions
  • Neuroma Amputation
  • Pain
  • Amputation

Treatment Effectiveness

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Tinel's sign at 3 months; Tinel's sign at 6 months

Month 6
Grip strength
NPS
bMHQ
Month 6
Tinel's sign

Trial Safety

Trial Design

3 Treatment Groups

Traction Neurectomy
1 of 3
Targeted Muscle Reinnervation
1 of 3
Regenerative Peripheral Nerve Interface
1 of 3

Active Control

Experimental Treatment

39 Total Participants · 3 Treatment Groups

Primary Treatment: Digital nerve procedure · No Placebo Group · N/A

Targeted Muscle Reinnervation
Procedure
Experimental Group · 1 Intervention: Digital nerve procedure · Intervention Types: Procedure
Regenerative Peripheral Nerve Interface
Procedure
Experimental Group · 1 Intervention: Digital nerve procedure · Intervention Types: Procedure
Traction Neurectomy
Procedure
ActiveComparator Group · 1 Intervention: Digital nerve procedure · Intervention Types: Procedure

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: tinel's sign at 3 months; tinel's sign at 6 months

Who is running the clinical trial?

Indiana UniversityLead Sponsor
876 Previous Clinical Trials
749,687 Total Patients Enrolled
American Society for Surgery of the HandOTHER
8 Previous Clinical Trials
992 Total Patients Enrolled
Scott N Loewenstein, MDPrincipal InvestigatorIndiana University
Joshua Adkinson, MD5.01 ReviewsPrincipal Investigator - Indiana University
Indiana University

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People requiring amputations of one finger near the top of the hand.