This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
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
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
Parallel
NeuroSpan Bridge
DeviceThe 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
DeviceThe 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
DeviceA 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
Efficacy- Static two-point discrimination (s2PD) measured at 12 months.
This endpoint will examine the change in Static two-point discrimination (s2PD) measured at 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.
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.
Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 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.
Sensory function assessed by the British Medical Research Council grading system at 12 months.
This endpoint will examine sensory function assessed by the British Medical Research Council grading system at 12 months.
Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.
This endpoint will examine Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.
The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 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.
Decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.
This clinical measure will examine the decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.
Comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.
This clinical measure will examine the comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.
Changes in Numerical Rating Scale (NRS) pain scores from baseline.
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'.
Hospital/Outpatient center readmission rates within 30 days of surgery.
This clinical measure will examine the Hospital/Outpatient center readmission rates within 30 days of surgery
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Auxilium Biotechnologies
Lead sponsor
MCRA
Collaborator
