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

TL;DR

A new sutureless method using a bioresorbable polymer successfully repaired digital nerves in 12 patients, showing safety and effectiveness over 12 months.

Contribution

The study introduces a sutureless nerve repair technique using a PGSA polymer device, validated in a clinical trial.

Findings

All patients achieved excellent or good sensory recovery at 12 months.

No device-related complications or pain were reported after 12 months.

Patients returned to work within a median of 41.5 days.

Abstract

Traditional microsurgical suture neurorrhaphy presents challenges such as fascicular trauma, scar formation, and variability in repair quality. This clinical study evaluates the safety and efficacy of a bioresorbable poly(glycerol sebacate) acrylate (PGSA) polymer-assisted device in digital nerve repair without sutures.

A single-arm clinical trial enrolled 12 patients with digital nerve injuries at two centers. The repair involved securing severed nerve ends within a 3-dimensional printed PGSA coaptation chamber using a light-activated PGSA polymer. Patients were prospectively followed for 12 months with assessments including pain (visual analog scale pain score), sensory recovery (Semmes-Weinstein Monofilament and two-point discrimination), patient-reported outcomes (Impact of Hand Nerve Disorders Questionnaire v2.0), and high-resolution ultrasound imaging.

At 12 months, 10 patients who completed the study had a Semmes-Weinstein Monofilament score of 0.4 (“diminished light touch”) or better, with 100% achieving “Good” (S3+) or “Excellent” (S4) two-point discrimination scores. No patient reported pain at 12 months, and no device-related complications were recorded. Ultrasound confirmed intact repairs with no neuroma formation. All patients returned to work at a median time of 41.5 days.

Results from this study support the concept of sutureless repair of severed digital nerves using the PGSA polymer-assisted coaptation device by demonstrating that the PGSA polymer-assisted coaptation is safe, effective, and may be considered as an option for nerve approximation.

These findings support the potential for broader clinical applications of polymer-assisted sutureless nerve repair.

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