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

NCT ID: NCT00948025

Last Updated: 2020-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-12-31

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 phase (pilot phase) assesses projected differences expected between two treatment groups. The second phase of the study provides comparison data between the two treatment groups.

AVANCE Nerve Graft is current regulated in the United States as a 361 HCT/P Tissue for transplantation; not a Drug, Biologic, or Medical Device. Hollow tube conduits are currently regulated in the United States as medical devices.

Conditions

Traumatic Nerve Injury

Keywords

Peripheral Nerve Repair; Conduit; AVANCE; Neuroma Resection; Nerve Gap Repair; Digital Nerve Repair; Nerve Graft; Nerve Allograft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Avance Nerve Graft

Commercially available Avance Nerve Graft for repair of nerve gap

Group Type: ACTIVE_COMPARATOR

Processed Human Nerve Tissue

Intervention Type: OTHER

Implantation of appropriate length of processed human nerve tissue at time of surgery.

Hollow Tube Conduit

Commercially available hollow tube conduit for repair of nerve gap.

Group Type: ACTIVE_COMPARATOR

Hollow tube nerve conduit, synthetic or biosynthetic

Intervention Type: DEVICE

Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)

Interventions

Hollow tube nerve conduit, synthetic or biosynthetic

Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)

Intervention Type: DEVICE

Processed Human Nerve Tissue

Implantation of appropriate length of processed human nerve tissue at time of surgery.

Intervention Type: OTHER

Other Intervention Names

Neurotube; NeuroLac; NeuraGen; NeuroMatrix; NeuroFlex; Avance Nerve Graft

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Axogen Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erick W DeVinney

Role: STUDY_DIRECTOR

Axogen Corporation

Locations

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

Countries

United States

Other Identifiers

ANG-CP-004

Identifier Type: -

Identifier Source: org_study_id