Avance Nerve Graft for Peripheral Nerve Injury

(Nerve-RESTORE℠ Trial)

This trial tests two methods to repair damaged nerves in the arm: the Avance Nerve Graft and a sural nerve autograft. The goal is to determine which method is more effective for nerve repairs over 25 millimeters long. It targets individuals with completely severed arm nerves requiring repair within four months of injury. Participants should not have other nerve-related issues or treatments that could affect the results. As a Phase 4 trial, the treatment is already FDA-approved and proven effective, aiming to understand its benefits for a broader range of patients.

Research has shown that the Avance Nerve Graft is safe to use. In studies, many patients experienced improved sensation and movement after using Avance. Specifically, 77% of patients reported good results in sensation, and 36% showed improvement in movement. The FDA has approved Avance for adults and children as young as one month, supporting its safety.

Unlike the standard sural nerve autograft, which requires harvesting a nerve from the patient's own body, the Avance Nerve Graft is a processed nerve allograft derived from donated human nerves. This means it eliminates the need for a secondary surgical site, reducing patient morbidity. Researchers are excited about Avance because it offers a promising alternative that could improve recovery outcomes for patients with large nerve gaps, potentially leading to faster and more effective nerve regeneration.

This trial will compare the Avance Nerve Graft with the Sural nerve autograft for repairing damaged nerves. Research has shown that the Avance Nerve Graft effectively repairs damaged nerves. In earlier studies, patients using Avance experienced noticeable improvements in sensation and movement after nerve repair. The graft aids nerve regeneration by providing a structure for new nerve fibers to develop. This treatment has shown promising results in restoring function in injured nerves, particularly those with gaps larger than 25 mm. Since its approval, the Avance Nerve Graft has been recognized for its effectiveness in aiding nerve recovery.