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Pain After Proximal Digital Amputation Prevention (PAPDAP)

Primary Purpose

Pain, Amputation Neuroma, Amputation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital nerve procedure
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Amputation Neuroma, Finger Amputation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eskenazi Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Traction Neurectomy

Targeted Muscle Reinnervation

Regenerative Peripheral Nerve Interface

Arm Description

Traction neurectomy - of digital sensory nerves at the time of amputation.

Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation

Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation

Outcomes

Primary Outcome Measures

bMHQ
Breif Michigan Hand Questionnaire Score difference

Secondary Outcome Measures

NPS
Numerical Pain Score difference
Grip strength
Grip strength score difference

Full Information

First Posted
May 4, 2020
Last Updated
August 28, 2023
Sponsor
Indiana University
Collaborators
American Society for Surgery of the Hand
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1. Study Identification

Unique Protocol Identification Number
NCT04378062
Brief Title
Pain After Proximal Digital Amputation Prevention
Acronym
PAPDAP
Official Title
Pain After Proximal Digital Amputation Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
inadequate enrollment
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
February 1, 2023 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
American Society for Surgery of the Hand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Amputation Neuroma, Amputation
Keywords
Pain, Amputation Neuroma, Finger Amputation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traction Neurectomy
Arm Type
Active Comparator
Arm Description
Traction neurectomy - of digital sensory nerves at the time of amputation.
Arm Title
Targeted Muscle Reinnervation
Arm Type
Experimental
Arm Description
Targeted Muscle Reinnervation - of digital sensory nerves at the time of amputation
Arm Title
Regenerative Peripheral Nerve Interface
Arm Type
Experimental
Arm Description
Regenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation
Intervention Type
Procedure
Intervention Name(s)
Digital nerve procedure
Intervention Description
The type of procedure performed on the digital nerve at the time of amputation
Primary Outcome Measure Information:
Title
bMHQ
Description
Breif Michigan Hand Questionnaire Score difference
Time Frame
3 months postop minus preop; 6 months postop minus preop
Secondary Outcome Measure Information:
Title
NPS
Description
Numerical Pain Score difference
Time Frame
3 months postop minus preop; 6 months postop minus preop
Title
Grip strength
Description
Grip strength score difference
Time Frame
3 months postop minus preop; 6 months postop minus preop
Other Pre-specified Outcome Measures:
Title
Tinel's sign
Description
Tinel's sign at amputation site
Time Frame
Tinel's sign at 3 months; Tinel's sign at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Adkinson, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Scott N Loewenstein, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Pain After Proximal Digital Amputation Prevention

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