Status:
TERMINATED
A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options
Lead Sponsor:
Axogen Corporation
Conditions:
Traumatic Nerve Injury
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand.
Detailed Description
The CHANGE study is a post-marketing study designed as a prospective, single-blind, randomized, two phase study comparing clinical outcomes of AVANCE Nerve Graft to hollow tube conduits. The first pha...
Eligibility Criteria
Inclusion
- Require primary or secondary nerve injury repair with Hollow Nerve Conduit or AVANCE™ in at least 1 digital nerve;
- Undergo End to End nerve to nerve graft coaptation on both the proximal and distal portion of the nerve gap in the AVANCE™ group or nerve entubulation in the Hollow Nerve Conduit group;
- Be willing to comply with all aspects of the treatment and evaluation schedule over a 12 Month duration; and
- Sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures.
Exclusion
- Nerve gaps of \< 5 mm or \> 20 mm;
- Estimated distance of regeneration of \>125 mm (distance from injury site to sensory target)
- Nerve crush or avulsion injuries;
- Incomplete nerve transections;
- Injury requiring replantation of target digit;
- Contralateral digital injuries corresponding to the target digit;
- Nerve injuries in the affected limb proximal to the crease of the wrist;
- End to side nerve repair;
- Injuries with significant vascular damage which may impair adequate perfusion of the target limb;
- Subjects who are undergoing treatment with chemotherapy, radiation therapy, or other know treatment which affects the growth of neural and/or vascular system;
- Use of bovine collagen based hollow nerve conduit in a subject with known or suspected bovine sensitivity;
- Subjects age ≤18 years or ≥70 years;
- History neuropathy, diabetic or any other known neuropathy;
- Secondary nerve repair \>12 weeks post initial injury;
- Currently enrolled in another investigational study;
- Expected use of medications during the study that are known to cause peripheral neuropathy;
- History or Reynaud's or other disorder known to compromise circulation or sensation in the upper extremity; and
- Any subject who at the discretion of the Investigator is not suitable for inclusion in the study.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00948025
Start Date
June 1 2009
End Date
December 1 2014
Last Update
December 1 2020
Active Locations (4)
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1
Georgia Hand, Shoulder and Elbow
Atlanta, Georgia, United States, 30309
2
Indiana Hand Center
Indianapolis, Indiana, United States, 46260
3
University of Kentucky
Lexington, Kentucky, United States, 40536
4
Curtis National Hand Center
Baltimore, Maryland, United States, 21218