A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair

Description

This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.

Conditions

Peripheral Nerve Injuries

Talk to us

Study Overview

On this page

Study Details

Study overview

This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.

A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)

A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair

Condition
Peripheral Nerve Injuries
Intervention / Treatment

-

Contacts and Locations

San Francisco

UCSF Orthopedic Institute, San Francisco, California, United States, 94158

New York

NYU Langone Orthopedic Center, New York, New York, United States, 10003

Columbus

OSU Wexner Medical Center, Columbus, Ohio, United States, 43212

Philadelphia

University of Pennsylvania- Penn Presbyterian Medical Center, Philadelphia, Pennsylvania, United States, 19104

San Antonio

The San Antonio Orthopaedic Group (TSAOG Orthopaedics), San Antonio, Texas, United States, 78258

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm.
  • 2. Nerve diameter at injury site ≤3mm.
  • 3. Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot.
  • 4. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm
  • 5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
  • 6. Repair must take place within 3 months from injury
  • 7. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)
  • 1. Previous history of nerve repair attempt at the treated nerve.
  • 2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
  • 3. Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
  • 4. Pregnancy or planning to become pregnant

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Auxilium Biotechnologies,

Study Record Dates

2028-08