Clinical trial NCT01809002: Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair
Official title: A Multicenter, Prospective, Randomized, Subject and Evaluator Blinded Comparative Study of Nerve Cuffs and Avance® Nerve Graft Evaluating Recovery Outcomes for the Repair of Nerve Discontinuities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Peripheral Nerve Discontinuities
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.


Eligibility criteria: Inclusion Criteria:

* Peripheral Nerve Injury

Exclusion Criteria:

* Peripheral Neuropathy
* Allergic to Bovine products such as Bovine Collagen Nerve Cuff

Primary outcomes:
measure: Static Two-Point Discrimination (Pre-defined Mixed Modeling Approach)
timeFrame: Month 12
measure: Static Two-Point Discrimination (Data As-reported)
timeFrame: Up to Month 12
Secondary outcomes:
measure: Response Rate for Recovery of s2PD at Month 12 (Data As-Reported)
timeFrame: Month 12
measure: Percent Recovery to Pre-Injury Baseline (Contralateral Control Value) s2PD at Month 12 (Pre-defined Modeling Approach)
timeFrame: Month 12
measure: Time to Recovery of s2PD (Data As-reported)
timeFrame: Assessed at Month 3, Month 6, Month 9, Month 12 (some patients were seen for their 12-month visit up to 15 calendar months post-op)
measure: Medical Research Council (MRC) Classification for Sensory Function Scores at Month 12 (Data As-reported)
timeFrame: Month 12
measure: Change in Pain Visual Analogue Scale (VAS) Scores at Month 12 (Pre-defined Modeling Approach)
timeFrame: Month 12
Other outcomes:
measure: Number of Participants With Persistent and Unresolved Pain (Data As-reported)
timeFrame: Operative Day+1, Month 1, Month 3, Month 6, Month 9, Month 12
Locations:
city: Sacramento
country: United States
facility: University California, Davis
state: California
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Tampa
country: United States
facility: Florida Orthopaedic Institute
state: Florida
city: Indianapolis
country: United States
facility: Indiana Hand to Shoulder 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
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Minneapolis
country: United States
facility: Hennepin Healthcare
state: Minnesota
city: Las Vegas
country: United States
facility: Hand Surgery Specialists of Nevada
state: Nevada
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Medical Center
state: North Carolina
city: Hershey
country: United States
facility: Penn State Universtiy
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Charlottesville
country: United States
facility: Univeristy of Virginia
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Huntington
country: United States
facility: Marshall Orthopaedics
state: West Virginia
Study officials:
affiliation: Virginia Commonwealth University Medical Center
name: Jonathan E Isaacs, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: L. Scott Levin, MD FACS
role: PRINCIPAL_INVESTIGATOR
References: