Pain After Proximal Digital Amputation Prevention (PAPDAP)

Finger amputations are common and may be complicated by debilitating nerve pain. This study seeks to determine if nerve pain after digital amputation can be more effectively prevented with either of two new surgical techniques-targeted muscle reinnervation (TMR) or regenerative peripheral nerve interfaces (RPNI)-compared to standard treatment by traction neurectomy (TN).

Study Overview

• Status: Terminated
• Conditions: Pain; Amputation; Amputation Neuroma
• Intervention / Treatment: Procedure: Digital nerve procedure

Detailed Description

Patients who require proximal amputations will have the opportunity to enroll in the study, will be randomized intraoperatively to receiving one of the aforementioned treatments, and will be followed at 3 and 6 month for outcome measures.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Eskenazi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients requiring single finger amputations at the level of the proximal interphalangeal joint or proximal (i.e., closer to the body than this joint).
• Patients have the capacity to complete the informed consent process

Exclusion Criteria:

• Patients less than 18 years of age, prisoner, or other vulnerable population
• Patients with significant concomitant ipsilateral extremity injuries that would confound study
• Patients requiring emergent, staged (guillotine-type) amputations of any kind

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Traction Neurectomy; Traction neurectomy - of digital sensory nerves at the time of amputation.	Procedure: Digital nerve procedure; The type of procedure performed on the digital nerve at the time of amputation
Experimental: Targeted Muscle Reinnervation; Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation	Procedure: Digital nerve procedure; The type of procedure performed on the digital nerve at the time of amputation
Experimental: Regenerative Peripheral Nerve Interface; Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation	Procedure: Digital nerve procedure; The type of procedure performed on the digital nerve at the time of amputation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
bMHQ	Breif Michigan Hand Questionnaire Score difference	3 months postop minus preop; 6 months postop minus preop

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NPS	Numerical Pain Score difference	3 months postop minus preop; 6 months postop minus preop
Grip strength	Grip strength score difference	3 months postop minus preop; 6 months postop minus preop

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinel's sign	Tinel's sign at amputation site	Tinel's sign at 3 months; Tinel's sign at 6 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: American Society for Surgery of the Hand
• Investigators: Principal Investigator: Joshua Adkinson, MD, Indiana University; Principal Investigator: Scott N Loewenstein, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): February 1, 2023
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 30, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Finger Amputation; Amputation Neuroma
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nerve Sheath Neoplasms; Neuroma
• Other Study ID Numbers: 1907889836

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No