A Sutureless Approach to Nerve Repair: Results From a Clinical Study in Digital Nerves

Area of Science:

• Biomaterials science
• Regenerative medicine
• Neurosurgery

Background:

• Traditional suture neurorrhaphy for digital nerve repair faces challenges including fascicular trauma, scar formation, and inconsistent outcomes.
• A novel approach is needed to improve the safety and efficacy of digital nerve repair.

Purpose of the Study:

• To evaluate the safety and efficacy of a bioresorbable poly(glycerol sebacate) acrylate (PGSA) polymer-assisted device for sutureless digital nerve repair.
• To assess functional recovery and patient-reported outcomes following PGSA device-assisted nerve repair.

Main Methods:

• A single-arm clinical trial involving 12 patients with digital nerve injuries.
• Nerve repair was performed using a 3D-printed PGSA coaptation chamber and light-activated PGSA polymer.
• Patients were followed for 12 months, with assessments including sensory recovery, pain, patient-reported outcomes, and ultrasound imaging.

Main Results:

• At 12 months, 100% of patients achieved "Good" or "Excellent" two-point discrimination scores.
• No patients reported pain, and no device-related complications were observed.
• Ultrasound confirmed intact repairs without neuroma formation, and patients returned to work quickly.

Conclusions:

• The PGSA polymer-assisted coaptation device is safe and effective for sutureless digital nerve repair.
• This technology presents a viable alternative to traditional suturing for nerve approximation.
• Findings support broader clinical applications for polymer-assisted sutureless nerve repair.