Clinical trial NCT00948025: A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Traumatic Nerve Injury
Keywords: Peripheral Nerve Repair
Conduit
AVANCE
Neuroma Resection
Nerve Gap Repair
Digital Nerve Repair
Nerve Graft
Nerve Allograft
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2009-07-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Recovery of Static 2-point Discrimination in the Affected Digit
timeFrame: 12 Months
Secondary outcomes:
measure: Moving 2-point Discrimination
timeFrame: 12 months
measure: Semmes-Weinstein Monofilament Assessment
timeFrame: 12 months
measure: 12-month DASH Core Module Scores
timeFrame: 12 months
measure: 12-month DASH (Work Module) Scores
timeFrame: 12 month
measure: 12- Month DASH (Sports/Performing Arts Module)
timeFrame: 12 months
measure: Pain at 12-months
timeFrame: 12-months
measure: Thermal Discretion at 12-months
timeFrame: 12-month
measure: Protective Sensation Present at 12-months
timeFrame: 12 months
measure: Functional Recovery Classification (Medical Research Council Evaluation of Sensory Function) at 12-months
timeFrame: 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Georgia Hand, Shoulder and Elbow
state: Georgia
city: Indianapolis
country: United States
facility: Indiana Hand Center
state: Indiana
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Baltimore
country: United States
facility: Curtis National Hand Center
state: Maryland
Study officials:
affiliation: Axogen Corporation
name: Erick W DeVinney
role: STUDY_DIRECTOR
References: