Peripheral Nerve Injuries
Conditions
Brief summary
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
Interventions
DEVICENeuroSpan 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 stump.
DEVICENeuroGen 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 Factor.
DEVICENerve 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
Sponsors
Auxilium Biotechnologies
MCRA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
A total of 80 subjects will be enrolled and randomized using a 1:1 ratio.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy- Static two-point discrimination (s2PD) measured at 12 months. | 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. | 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
| Measure | Time frame | Description |
|---|---|---|
| Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months. | 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. | 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. | 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. | 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. |
| The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months. | 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. |
| The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months. | 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. |
Countries
United States
Contacts
CONTACTJacob Koffler, PhD, MBA
Outcome results
None listed