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

Recruiting

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

Who can join

Ages 18 to 80 · All sexes

Full 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

About the study

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

What is being tested

Sponsor: Auxilium Biotechnologies · Participants: 80 · Started: Mar 21, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06529835

Locations in the U.S.

CaliforniaUC San Diego Health, San Diego
UCSF Orthopedic Institute, San Francisco
MarylandMedstar Union Memorial Hospital- The Curtis National Hand Center, Baltimore
New YorkNYU Langone Orthopedic Center, New York
OhioOSU Wexner Medical Center, Columbus
PennsylvaniaUniversity of Pennsylvania- Penn Presbyterian Medical Center, Philadelphia
TexasUT Health Houston, Houston
The San Antonio Orthopaedic Group (TSAOG Orthopaedics), San Antonio

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.