Comparing different methods for repairing peripheral nerve injuries

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

This study is testing three different ways to fix nerve injuries to see which method helps people heal better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Auxilium Biotechnologies (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 6 sites (San Francisco, California and 5 other locations)
• Trial ID: NCT06529835 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of three different approaches for repairing peripheral nerve injuries: the NeuroSpan Bridge, the NeuraGen Nerve Guide, and traditional nerve autograft. It is a multicenter, prospective, randomized trial where both subjects and evaluators are blinded to ensure unbiased results. Participants will be selected based on specific criteria related to their nerve injury, and the repair must occur within three months of the injury. The study aims to determine which method provides the best outcomes for nerve repair.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with specific types of upper or lower extremity nerve injuries that meet the study's criteria.

Not a fit: Patients with previous nerve repair attempts or concurrent diseases that impair nerve regeneration may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved recovery and functionality for patients with peripheral nerve injuries.

How similar studies have performed: Other studies have explored nerve repair techniques, but this specific comparison of these three methods is novel.

Eligibility criteria

Inclusion 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)

Exclusion Criteria:

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

Where this trial is running

San Francisco, California and 5 other locations

• UCSF Orthopedic Institute — San Francisco, California, United States (Recruiting)
• Medstar Union Memorial Hospital- The Curtis National Hand Center — Baltimore, Maryland, United States (Recruiting)
• NYU Langone Orthopedic Center — New York, New York, United States (Recruiting)
• OSU Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
• University of Pennsylvania- Penn Presbyterian Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
• The San Antonio Orthopaedic Group (TSAOG Orthopaedics) — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Jacob Koffler, PhD, MBA

Conditions Peripheral Nerve Injuries