Comparing different methods for repairing peripheral nerve injuries

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• UC San Diego Health
  San Diego, California, United States Recruiting
• 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

Study contacts

• Study coordinator: Jacob Koffler, PhD, MBA
• Email: j.koffler@auxiliumbio.com
• Phone: 858-699-9443

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.