A Comparison of NeuroSpan Bridge, NeuraGen Nerve Guide, and Nerve Autograft for Peripheral Nerve Repair

Not Applicable

Recruiting

• Conditions: Peripheral Nerve Injuries
• Interventions: Device: NeuroSpan Bridge; Device: NeuroGen Nerve Guide; Device: Nerve Autograft

• Registration Number: NCT06529835
• Lead Sponsor: Auxilium Biotechnologies

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-07-29
• Study First Posted: 2024-07-31
• Study Start: 2025-03-21
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NeuroGen Nerve Guide	NeuroSpan Bridge	The control arm will comprise of subjects requiring injury repair of 0.5-1.0cm. These subjects will receive the NeuraGen Nerve Guide.
NeuroGen Nerve Guide	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.
Nerve Autograft	NeuroSpan Bridge	The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.
Nerve Autograft	Nerve Autograft	The control arm will comprise of subjects requiring injury repair of 1.1-3.0cm. These subjects will receive the Nerve Autograft.

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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) 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.
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) 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.
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.

Trial Locations

Locations (5)

UCSF Orthopedic Institute; 🇺🇸 San Francisco, California, United States

OSU Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States

NYU Langone Orthopedic Center; 🇺🇸 New York, New York, United States

University of Pennsylvania- Penn Presbyterian Medical Center; 🇺🇸 Philadelphia, Pennsylvania, United States

The San Antonio Orthopaedic Group (TSAOG Orthopaedics); 🇺🇸 San Antonio, Texas, United States