Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair

NCT ID: NCT01809002

Last Updated: 2023-07-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2021-08-30

Brief Summary

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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.

Detailed Description

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Conditions

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Peripheral Nerve Discontinuities

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Processed Nerve Allograft

Processed Nerve Allograft

Group Type EXPERIMENTAL

Processed Nerve Allograft (human)

Intervention Type BIOLOGICAL

Collagen Nerve Cuff

Group Type ACTIVE_COMPARATOR

Collagen Nerve Cuff

Intervention Type DEVICE

Bovine collagen based nerve cuff

Interventions

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Processed Nerve Allograft (human)

Intervention Type BIOLOGICAL

Collagen Nerve Cuff

Bovine collagen based nerve cuff

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Peripheral Nerve Injury

Exclusion Criteria

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

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Axogen Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jonathan E Isaacs, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Medical Center

L. Scott Levin, MD FACS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University California, Davis

Sacramento, California, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Florida Orthopaedic Institute

Tampa, Florida, United States

Site Status

Indiana Hand to Shoulder Center

Indianapolis, Indiana, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Curtis National Hand Center

Baltimore, Maryland, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Hennepin Healthcare

Minneapolis, Minnesota, United States

Site Status

Hand Surgery Specialists of Nevada

Las Vegas, Nevada, United States

Site Status

University of Rochester Medical Center

Rochester, New York, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Wake Forest Medical Center

Winston-Salem, North Carolina, United States

Site Status

Penn State Universtiy

Hershey, Pennsylvania, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Rothman Institute

Philadelphia, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Univeristy of Virginia

Charlottesville, Virginia, United States

Site Status

Virginia Commonwealth University Medical Center

Richmond, Virginia, United States

Site Status

Marshall Orthopaedics

Huntington, West Virginia, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ANG-CP-007

Identifier Type: -

Identifier Source: org_study_id

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