A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options

Stopped early · Not applicable

Conditions studied: Traumatic Nerve Injury

In brief

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.

Key facts

Study ID

NCT00948025

Run by

Axogen Corporation

People needed

23

Starts

2009-06-01

Expected to finish

2014-12-01

Last updated by the study team

2020-12-01

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Georgia Hand, Shoulder and Elbow — Atlanta, Georgia, United States
• Indiana Hand Center — Indianapolis, Indiana, United States
• University of Kentucky — Lexington, Kentucky, United States
• Curtis National Hand Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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