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

Axogen Corporation23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Traumatic Nerve Injury

Interventions

Hollow tube nerve conduit, synthetic or biosyntheticDEVICE

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

Processed Human Nerve TissueOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (4)

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

Outcomes

Primary Outcomes

Recovery of Static 2-point Discrimination in the Affected Digit

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

Time frame: 12 Months

Secondary Outcomes

Moving 2-point Discrimination

Percent Change from Baseline of Moving 2-Point Discriminations at Month 12

Time frame: 12 months

Semmes-Weinstein Monofilament Assessment

Percent Change from Baseline of Semmes-Weinstein Monofilament Assessment at Month 12

Time frame: 12 months

12-month DASH Core Module Scores

Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Core Module) at Month 12 The Disabilities of the Arm, Shoulder and Hand (DASH) core module questionnaire is a 30-item questionnaire includes 21 physical function items, 6 symptom items, and 3 social/role function items. It is a patient reported questionnaire used to assess physical function and severity of symptoms in patients with musculoskeletal disorders of the upper limb. Each of the items in the DASH use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula (\[sum of n responses)/ - 30 (minimum score\]/1.2 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no disability) to 100 (most severe disability).

Time frame: 12 months

12-month DASH (Work Module) Scores

Summary of Disability of the Arm, Shoulder, and Hand (DASH) scores (Work Module) at Month 12 The Disabilities of the Arm, Shoulder and Hand (DASH) Work Module questionnaire is a 4-item questionnaire used to identify the job-specific difficulties that workers might experience but which may not affect their activities of daily living. It is a patient reported questionnaire used to assess the impact that musculoskeletal disorders of the upper limb have on a patient's ability to perform work-related tasks. Each of the items in the DASH Work Module use a 5-point Likert scale to assess the corresponding severity or functional parameter. The outcome measure is scored based on the formula (\[sum of n responses)/ - 4 (minimum score\]/0.16 (range of scores ÷100), where n represents the number of completed items. Computed scores range from 0 (no difficulty) to 100 (most severe difficulty).

Data from ClinicalTrials.gov

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