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NCT Number: NCT06529835

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

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

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Key information

Conditions

Peripheral Nerve Injuries Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 ≤3mm.
  • 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 site of injury to the nearest innervated muscle: ≤100mm
  • For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm
  • Repair must take place within 3 months from injury
  • No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite)

Exclusion criteria

  • Previous history of nerve repair attempt at the treated nerve.
  • Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy.
  • Allergy to Bovine products such as Bovine Collagen Nerve Cuff.
  • Pregnancy or planning to become pregnant

Treatment and study plan

NeuroSpan Bridge

Device

The implant is used to connect peripheral nerve discontinuities. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap.

The NeuroSpan Bridge is a novel scaffold to support regeneration that mimics the natural bio- architecture, providing multiple channels that are strictly linear so that axonal position is accurately maintained across the full length of the scaffold - over any length - to re-enter the distal nerve stump.

NeuroGen Nerve Guide

Device

The NeuraGen Nerve Guide is a resorbable implant for the repair of 0.5-1.0cm peripheral nerve discontinuities. NeuraGen Nerve Guide provides a protective environment for peripheral nerve repair after injury. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap. The semi-permeable type 1 collagen membrane allows for controlled resorption, appropriate nutrient diffusion and retention of representative Nerve Growth Factor.

Nerve Autograft

Device

A nerve autograft is a surgical procedure that involves transplanting a segment of a patient's own sensory nerve tissue to repair a damaged peripheral nerve injury measuring 1.1-3.0cm. It is designed to be an interface between the nerve and surrounding tissue and to create a conduit for axonal growth across a nerve gap

Primary outcomes

  1. Efficacy- Static two-point discrimination (s2PD) measured at 12 months.

    Time frame: 12 months

    This endpoint will examine the change in Static two-point discrimination (s2PD) measured at 12 months.

  2. Safety- Complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.

    Time frame: 12 months

    This endpoint will examine complications and adverse events including infections, inflammation, tissue rejections, neuroma formation, chronic pain, and device malfunctions occurring between the treatment procedure and the 12-month follow-up visit.

Secondary outcomes

  1. Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.

    Time frame: 12 months

    This endpoint will examine motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.

  2. Sensory function assessed by the British Medical Research Council grading system at 12 months.

    Time frame: 12 months

    This endpoint will examine sensory function assessed by the British Medical Research Council grading system at 12 months.

  3. Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.

    Time frame: 12 months

    This endpoint will examine Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.

  4. The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.

    Time frame: 12 months

    This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.

    The Disabilities of the Arm Shoulder and Hand (DASH) is a 30-item patient-reported outcome measure utilized to assess symptoms and function of the entire upper extremity. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.

  5. The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.

    Time frame: 12 months

    This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.

    The Disabilities of the Arm Shoulder and Hand (DASH) Work Module is a 4 question patient-reported outcome measure utilized to assess the impact of the patients arm, shoulder, or hand problem on the patients ability to work. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.

  6. The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months.

    Time frame: 12 months

    This endpoint will examine the summary score from the Disabilities of the Arm Shoulder and Hand (Dash) Sports/Performing Arts Module at 12 months.

    The Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module is a 4 question patient-reported outcome measure utilized to assess the impact of the patients arm, shoulder, or hand problem on their ability to play a musical instrument, participate in sport or both. It is scored using the 5-point Likert-Scale measuring from "1" (lowest level of difficulty or severity) to 5" (highest level of difficulty or severity) based on the patient's reported ability to conduct the activities or tasks. A higher score indicates greater disability.

Other outcomes

  1. Decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.

    Time frame: 12 months

    This clinical measure will examine the decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.

  2. Comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.

    Time frame: 12 months

    This clinical measure will examine the comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.

  3. Changes in Numerical Rating Scale (NRS) pain scores from baseline.

    Time frame: 12 months

    This clinical measure will examine changes in Numerical Rating Scale (NRS) pain scores from baseline. Numerical Rating Scale (NRS) is a pain scale that measures a patient's pain intensity or other features. Patients are asked to circle the number between 0 and 10 that fits best to their pain intensity. Zero usually represents 'no pain at all' whereas the 10 represents 'the worst pain ever possible'.

  4. Hospital/Outpatient center readmission rates within 30 days of surgery.

    Time frame: 30 days

    This clinical measure will examine the Hospital/Outpatient center readmission rates within 30 days of surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Jacob Koffler, PhD, MBA

CONTACT

[email protected]

858-699-9443

Sponsors and collaborators

Lead sponsor

Auxilium Biotechnologies

Industry

Collaborators

  • MCRA

Registry information

Official study title

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

Acronym: NeuroSpan-1

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 31, 2024
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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