Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury
Study Overview
Status
Intervention / Treatment
Detailed Description
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150 years much research has been performed. PEG-Axon fusion on the other hand is relatively new in mammals. Success has already been obtained by two institutions in the rat sciatic nerve transections, demonstrating rapid return of behavioral function4. These however are very controlled injuries and unclear how well these will translate into human studies. For this reason 3 separate clinical studies in increasing order of complexity are proposed.
The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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-
Pennsylvania
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York, Pennsylvania, United States, 17405
- WellSpanYork Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- Isolated nerve transections of the digits, forearm, wrist, and palm will be included.
- Class III nerve injury (Sunderland's 4th or 5th degree injury)
- Nerve injuries that can be prepared using minimal or acceptable tension (according to surgeon discretion).
- Pregnant and breastfeeding women cannot participate because of possible unknown and unpredictable risks to the unborn child.
- Injuries beyond 24 hours will be excluded
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nerve injury to palm and fingers
Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited
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Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
Time Frame: 12 months
|
Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair.
This will demonstrate the safety and efficacy of the procedure
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Richard C Trevino, MD, WellSpan York Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 696230-1
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