A prospective randomised clinical study of Amniox’s Clarix regenerative matrix used as an adjunct to lumbar discectomy has found statistically significant improvements on Oswestry Disability Index and Short Form-12 (physical component scale) scores at six months and two years.
The findings were presented at the North American Spine Society 2016 Annual Meeting (NASS), by the study’s lead investigator, D Greg Anderson of the Rothman Institute in Philadelphia, USA.
The study included 80 patients, with half of the patients receiving Clarix 100 in the disc space following removal of the disc herniation and half receiving the standard of care which involved removal of the herniation alone. Patients treated with Clarix saw statistically significant improvement in Oswestry Disability Index (ODI) scores and Short Form-12 (physical composite scale) at six weeks and two years. The study also reports that there were no recurrent herniations in the Clarix treatment group during the two-year follow-up period, compared to a 7.5% recurrence rate in the control group.
“Degenerative disc disease is the most common source of back pain, and lumbar discectomy is the most common surgical intervention to treat this condition. However, residual back pain and recurrent herniations can be as high as 20%” says Anderson, professor in the Departments of Orthopaedic and Neurological Surgery at Thomas Jefferson University and clinical director of the Spine Section of the Orthopaedic Research Laboratory (Philadelphia, USA). “These results indicate that the application of Clarix can influence the healing response to significantly improve post-surgical outcomes. Patients experience reduced pain and a faster and sustained return to activities of daily living. Additionally, although it was not an endpoint identified in the study protocol, we observed a reduction in the use of narcotics in the patients treated with Clarix.”
According to a press release, restorative ability is innate to these human umbilical cord and amniotic membrane tissues, and can be preserved and transplanted to adults. The release states that heavy chain hyaluronic acid/pentraxin-3 (HC-HA/PTX3) is the key protein complex present in these tissues to orchestrate that regenerative healing process. Amniox uses its proprietary CryoTek process, a cryopreservation technology, to preserve the biological and structural integrity of these tissues.