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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NeuroGen Nerve Guide | Active Comparator | The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide. |
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| Nerve Autograft | Active Comparator | The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Sensory function assessed by the British Medical Research Council grading system at 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacob Koffler, PhD, MBA | Contact | 858-699-9443 | j.koffler@auxiliumbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC San Diego Health | Recruiting | San Diego | California | 92103 | United States |
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A total of 80 subjects will be enrolled and randomized using a 1:1 ratio.
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Blinding will occur to the subject and the blinded assessor. The blinded assessor will remain blinded from the device that was implanted. For subjects, blinding will be accomplished by informing subjects during the consent process that they may or may not also receive a secondary procedure in which they could have an incision in their leg that is not dependent on the device in which they are randomized to receive. Blinding will be assessed by the use of blinding assessment to both the assessor at the patient at the 12 month follow-up visit.
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| 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. |
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| 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 |
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This endpoint will examine sensory function assessed by the British Medical Research Council grading system at 12 months. |
| 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. | 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. | 12 months |
| The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 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. | 12 months |
| The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 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. | 12 months |
This clinical measure will examine the comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide. |
| 12 months |
| 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'. | 12 months |
| 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 | 30 days |
| UCSF Orthopedic Institute | Recruiting | San Francisco | California | 94158 | United States |
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| Medstar Union Memorial Hospital- The Curtis National Hand Center | Recruiting | Baltimore | Maryland | 21218 | United States |
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| NYU Langone Orthopedic Center | Recruiting | New York | New York | 10003 | United States |
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| OSU Wexner Medical Center | Recruiting | Columbus | Ohio | 43212 | United States |
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| University of Pennsylvania- Penn Presbyterian Medical Center | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| UT Health Houston | Recruiting | Houston | Texas | 77030 | United States |
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| The San Antonio Orthopaedic Group (TSAOG Orthopaedics) | Recruiting | San Antonio | Texas | 78258 | United States |
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| ID | Term |
|---|---|
| D059348 | Peripheral Nerve Injuries |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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