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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AxoGen, Inc
ClinicalTrials.gov Identifier:
NCT00948025
First received: July 17, 2009
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

This study is a comparison of sensory recovery outcomes from the use of AVANCE and hollow tube conduits for peripheral nerve gap repairs in the hand.


Condition Intervention Phase
Traumatic Nerve Injury
Device: Hollow tube nerve conduit, synthetic or biosynthetic
Other: Processed Human Nerve Tissue Scaffold
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Prospective, Randomized, Comparative Study of Hollow Nerve Conduit and Avance Nerve Graft Evaluating Recovery Outcomes of Nerve Repair in the Hand. (CHANGE)

Further study details as provided by AxoGen, Inc:

Primary Outcome Measures:
  • Recovery of Static Two-point Discrimination in Target Digit [ Time Frame: 1, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Recovery of Moving Two-Point Discrimination in Target Digit [ Time Frame: 1, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]
  • Recovery of Sensation Assessed by Semmes-Weinstein Monofilament Testing in Target Digit [ Time Frame: 1, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]
  • DASH Questionnaire Score for Affect Hand [ Time Frame: 1, 3, 6, 9 and 12 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 165
Study Start Date: June 2009
Estimated Study Completion Date: April 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Avance Nerve Graft
Commercially available Avance Nerve Graft for repair of nerve gap
Other: Processed Human Nerve Tissue Scaffold
Implantation of appropriate length of processed human nerve tissue scaffold at time of surgery.
Active Comparator: Hollow Tube Conduit
Commercially available hollow tube conduit for repair of nerve gap.
Device: Hollow tube nerve conduit, synthetic or biosynthetic
Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)
Other Names:
  • Neurotube
  • NeuroLac
  • NeuraGen
  • NeuroMatrix
  • NeuroFlex

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948025

Locations
United States, Georgia
Georgia Hand, Shoulder and Elbow
Atlanta, Georgia, United States, 30309
United States, Indiana
Indiana Hand Center
Indianapolis, Indiana, United States, 46260
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40536
United States, Maryland
Curtis National Hand Center
Baltimore, Maryland, United States, 21218
Sponsors and Collaborators
AxoGen, Inc
  More Information

No publications provided

Responsible Party: AxoGen, Inc
ClinicalTrials.gov Identifier: NCT00948025     History of Changes
Other Study ID Numbers: ANG-CP-004
Study First Received: July 17, 2009
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by AxoGen, Inc:
Peripheral Nerve Repair
Conduit
AVANCE
Neuroma Resection
Nerve Gap Repair
Digital Nerve Repair

ClinicalTrials.gov processed this record on November 20, 2014