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

NCT00948025 | Terminated Results FDA Device

• 1 other identifier: ANG-CP-004
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 4

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.

Conditions

Traumatic Nerve Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Recovery of Static 2-point Discrimination in the Affected Digit

  Mean change in static 2-Point Discrimination between baseline and 12 months

  12 Months

Secondary Outcomes (9)

• Moving 2-point Discrimination

  12 months

• Semmes-Weinstein Monofilament Assessment

  12 months

• 12-month DASH Core Module Scores

  12 months

• 12-month DASH (Work Module) Scores

  12 month

• 12- Month DASH (Sports/Performing Arts Module)

  12 months

Study Arms (2)

Avance Nerve Graft

ACTIVE COMPARATOR

Commercially available Avance Nerve Graft for repair of nerve gap

Other: Processed Human Nerve Tissue

Hollow Tube Conduit

ACTIVE COMPARATOR

Commercially available hollow tube conduit for repair of nerve gap.

Device: Hollow tube nerve conduit, synthetic or biosynthetic

Interventions

Hollow tube nerve conduit, synthetic or biosynthetic DEVICE

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

Also known as: Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex

Hollow Tube Conduit

Processed Human Nerve Tissue OTHER

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

Also known as: Avance Nerve Graft

Avance Nerve Graft

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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;

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (4)

Georgia Hand, Shoulder and Elbow

Atlanta, Georgia, 30309, United States

Location

Indiana Hand Center

Indianapolis, Indiana, 46260, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Curtis National Hand Center

Baltimore, Maryland, 21218, United States

Location

Limitations and Caveats

1. Early termination due to planned changes in the regulatory status of the study product from an HC/T product to a licensed biologic (planned). 2. High loss-to-follow-up rate.

Results Point of Contact

• Title: Vice President, Clinical and Translational Sciences
• Organization: AxoGen, Inc

edevinney@axogeninc.com

3864626829

Study Officials

• Erick W DeVinney

  Axogen Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2009
• First Posted: July 29, 2009
• Study Start: June 1, 2009
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 1, 2020
• Results First Posted: December 1, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)