Study Stopped
inadequate enrollment
Pain After Proximal Digital Amputation Prevention
PAPDAP
1 other identifier
interventional
39
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pain
Started Mar 2020
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2020
CompletedFirst Submitted
Initial submission to the registry
May 4, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedAugust 30, 2023
August 1, 2023
2.9 years
May 4, 2020
August 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
bMHQ
Breif Michigan Hand Questionnaire Score difference
3 months postop minus preop; 6 months postop minus preop
Secondary Outcomes (2)
NPS
3 months postop minus preop; 6 months postop minus preop
Grip strength
3 months postop minus preop; 6 months postop minus preop
Other Outcomes (1)
Tinel's sign
Tinel's sign at 3 months; Tinel's sign at 6 months
Study Arms (3)
Traction Neurectomy
ACTIVE COMPARATORTraction neurectomy - of digital sensory nerves at the time of amputation.
Targeted Muscle Reinnervation
EXPERIMENTALTargeted Muscle Reinnervation - of digital sensory nerves at the time of amputation
Regenerative Peripheral Nerve Interface
EXPERIMENTALRegenerative Peripheral Nerve Interface - of digital sensory nerves at the time of amputation
Interventions
The type of procedure performed on the digital nerve at the time of amputation
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- American Society for Surgery of the Handcollaborator
Study Sites (1)
Eskenazi Hospital
Indianapolis, Indiana, 46202, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Adkinson, MD
Indiana University
- PRINCIPAL INVESTIGATOR
Scott N Loewenstein, MD
Indiana University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Surgery
Study Record Dates
First Submitted
May 4, 2020
First Posted
May 7, 2020
Study Start
March 1, 2020
Primary Completion
February 1, 2023
Study Completion
February 1, 2023
Last Updated
August 30, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share