A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair
NCT Number: NCT06529835
Acronym: NeuroSpan-1
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Peripheral Nerve Injuries
Interventions: DEVICE: NeuroSpan Bridge|DEVICE: NeuroGen Nerve Guide|DEVICE: Nerve Autograft
Sponsor: Auxilium Biotechnologies
Collaborators: MCRA
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2028-08

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

Primary Outcome Measures: 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
Secondary Outcome Measures: 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., 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
Other Outcome Measures: 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., 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