Results from a registry presented by Darrell Brooks, partner at The Buncke Clinic and principal investigator of the study, show that AxoGen’s Avance Nerve Graft is a safe method for reconstructing nerve discontinuities with 87.3% of the injuries achieving meaningful recovery. The study was presented at the 66th annual meeting for the American Society for Surgery of the Hand (ASSH), Las Vegas, USA.
“The data from the study will help change the treatment paradigm for surgeons with patients that have peripheral nerve discontinuities. It gives the surgeon a viable option for treatment of peripheral nerve injuries without the sacrifice of healthy nerve function,” Brooks commented.
AxoGen believes this study is the largest multicentre clinical study conducted to date in peripheral nerve gap reconstruction.
This twelve-centre clinical study shows an analysis of outcomes for patients with peripheral nerve injuries reconstructed with Avance Nerve Graft. The study enrolled 103 patients with 132 peripheral nerve injuries that were varied from traumatic injuries to surgical resections and included acute (reconstructed less than 3 weeks post-injury) to delayed (reconstructed more than 3 months post-injury) and multiple nerve types (sensory, motor and mixed nerves) in all regions of the body. This analysis included quantitative outcome data on a subgroup where 55 nerves were repaired with the Avance Nerve Graft using study centre standard of care for treatment as well as follow-up evaluation. The quantitative subgroup analysed consisted of patients with an average age of 44 years old. The average gap length in the transected nerve was 24.0 mm, with a range of 5 mm to 50 mm.
The study results demonstrate that Avance Nerve Graft is a safe method for reconstructing nerve discontinuities with 87.3% of the injuries achieving meaningful recovery. Meaningful recovery was achieved in a majority of cases regardless of nerve type repaired (including mixed and motor), increased age, prolonged time-to-repair, or larger gap length (up to 50mm) variables classically associated with poorer axon regeneration and prognosis. The Avance Nerve Graft did not see the length limitations historically observed with nerve conduits.