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

Официальное название

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

Обзор

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

Вмешательства

• Устройство NeuroSpan Bridge
  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
• Устройство NeuroGen Nerve Guide
  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 F
• Устройство Nerve Autograft
  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

Первичные конечные точки

• Efficacy- Static two-point discrimination (s2PD) measured at 12 months. [Срок оценки: 12 months]
• 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. [Срок оценки: 12 months]

Вторичные конечные точки (6)

• Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months. [Срок оценки: 12 months]
• Sensory function assessed by the British Medical Research Council grading system at 12 months. [Срок оценки: 12 months]
• Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months. [Срок оценки: 12 months]
• The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months. [Срок оценки: 12 months]
• The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months. [Срок оценки: 12 months]
• The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months. [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 8 центров

• UC San Diego Health — San Diego
• UCSF Orthopedic Institute — San Francisco
• Medstar Union Memorial Hospital- The Curtis National Hand Center — Baltimore
• NYU Langone Orthopedic Center — New York
• OSU Wexner Medical Center — Columbus
• University of Pennsylvania- Penn Presbyterian Medical Center — Philadelphia
• UT Health Houston — Houston
• The San Antonio Orthopaedic Group (TSAOG Orthopaedics) — San Antonio

Идентификаторы

NCT: NCT06529835 · AUX-NS-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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