Clinical trial NCT06529835: A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
Official title: A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair (NeuroSpan-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peripheral Nerve Injuries
Lead sponsor: Auxilium Biotechnologies
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2024-07-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A total of 80 subjects will be enrolled and randomized using a 1:1 ratio.
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Efficacy- Static two-point discrimination (s2PD) measured at 12 months.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Motor function assessed by the British Medical Research Council grading system (categories 0, 1, 2, 3, 4, 5) at 12 months.
timeFrame: 12 months
measure: Sensory function assessed by the British Medical Research Council grading system at 12 months.
timeFrame: 12 months
measure: Moving 2 Point Discrimination test (m2PD) in the target digit at 12 months.
timeFrame: 12 months
measure: The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) questionnaire at 12 months.
timeFrame: 12 months
measure: The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Work Module at 12 months.
timeFrame: 12 months
measure: The summary score from the Disabilities of the Arm Shoulder and Hand (DASH) Sports/Performing Arts Module at 12 months.
timeFrame: 12 months
Other outcomes:
measure: Decrease in Surgery time between NeuroSpan Bridge vs. Nerve Autograft.
timeFrame: 12 months
measure: Comparison in Surgery time between NeuroSpan Bridge vs. NeuraGen Nerve Guide.
timeFrame: 12 months
measure: Changes in Numerical Rating Scale (NRS) pain scores from baseline.
timeFrame: 12 months
measure: Hospital/Outpatient center readmission rates within 30 days of surgery.
timeFrame: 30 days
Locations:
city: San Francisco
country: United States
facility: UCSF Orthopedic Institute
state: California
city: New York
country: United States
facility: NYU Langone Orthopedic Center
state: New York
city: Columbus
country: United States
facility: OSU Wexner Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania- Penn Presbyterian Medical Center
state: Pennsylvania
city: San Antonio
country: United States
facility: The San Antonio Orthopaedic Group (TSAOG Orthopaedics)
state: Texas
Study officials:
References: