Actively Recruiting
A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Led by Auxilium Biotechnologies · Updated on 2025-11-10
80
Participants Needed
6
Research Sites
34 weeks
Total Duration
On this page
Sponsors
A
Auxilium Biotechnologies
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of Auxilium's NeuroSpan Bridge, a device designed to support nerve regeneration, in people with peripheral nerve injuries in the arms or legs. This prospective, randomized clinical trial compares the NeuroSpan Bridge with two other nerve repair methods: the NeuraGen Nerve Guide for nerve gaps of 0.5 to 1.0 cm and nerve autografts for gaps of 1.1 to 3.0 cm. The study is double-blinded, meaning both participants and evaluators do not know which treatment is given, to fairly assess the treatments' impacts. Participants will be assigned to one of three treatment groups based on the size of their nerve injury. Those with smaller gaps (0.5-1.0 cm) will receive the NeuraGen Nerve Guide, a resorbable implant that helps nerve repair by creating a protective conduit. Those with larger gaps (1.1-3.0 cm) will receive a nerve autograft, which transplants the patient's own nerve tissue to bridge the injury. The NeuroSpan Bridge, a novel device mimicking natural nerve structure with multiple linear channels, is used to support regeneration across any nerve gap length. Treatments aim to provide a conduit for nerve fibers to grow across the injury. Participants will be followed for 12 months after treatment to evaluate nerve function and safety. Assessments include static and moving two-point discrimination tests, motor and sensory function grading, and questionnaires about arm, shoulder, and hand disabilities. Researchers will monitor for complications such as infections, inflammation, tissue rejection, neuroma formation, chronic pain, and device malfunctions. This comprehensive follow-up will help determine how well each treatment supports nerve repair and overall recovery over a year.
CONDITIONS
Brief Title
A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm
- Nerve diameter at injury site 3 mm or less
- 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
- For motor nerve injuries: distance from injury to nearest innervated muscle is 100 mm or less
- For sensory and mixed nerve injuries: distance from injury to nearest sensory nerve target is 250 mm or less
- Repair must occur within 3 months from injury
- No contraindications to surgical repair such as risk of infection or dog bite
You will not qualify if you...
- Previous nerve repair attempt on the treated nerve
- Diseases that reduce nerve regeneration such as diabetes, non-traumatic peripheral neuropathy, or chemotherapy
- Allergy to bovine products like bovine collagen nerve cuff
- Pregnancy or planning to become pregnant
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure
Participants receive surgical repair of their peripheral nerve injury using either the NeuroSpan Bridge, NeuraGen Nerve Guide, or Nerve Autograft device depending on nerve gap size.
1 surgical visit
Duration - 12 months
Participants are monitored for recovery and potential complications following nerve repair surgery.
Approximately 6 post-operative visits
Trial Site Locations
Total: 6 locations
1
UCSF Orthopedic Institute
San Francisco, California, United States, 94158
Actively Recruiting
2
Medstar Union Memorial Hospital- The Curtis National Hand Center
Baltimore, Maryland, United States, 21218
Actively Recruiting
3
NYU Langone Orthopedic Center
New York, New York, United States, 10003
Actively Recruiting
4
OSU Wexner Medical Center
Columbus, Ohio, United States, 43212
Actively Recruiting
5
University of Pennsylvania- Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
San Antonio, Texas, United States, 78258
Actively Recruiting
Research Team
J
Jacob Koffler, PhD, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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