A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 80
- Locations
- 14
- Primary Endpoint
- 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.
Study Overview
Brief Summary
This is a multicenter, prospective, randomized, subject and evaluator blinded clinical trial to asses the efficacy of Auxilium's NeuroSpan Bridge.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, 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.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
NeuroGen Nerve Guide
The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.
Intervention: NeuroSpan Bridge (Device)
NeuroGen Nerve Guide
The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.
Intervention: NeuroGen Nerve Guide (Device)
Nerve Autograft
The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.
Intervention: NeuroSpan Bridge (Device)
Nerve Autograft
The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.
Intervention: Nerve Autograft (Device)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.(12 months)
- The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months.(12 months)
- 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) Work Module at 12 months.(12 months)
- 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.(12 months)