Improved outcomes found for lumbar discectomy with Amniox Clarix

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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.

1 COMMENT

  1. Interesting finding. I have long concluded that intradisical therapy , of which there are many variations starting with chymopapain, will be beneficial to enhance discectomy when used with or without discectomy for disc herniation. Earlier treatment produces better initial and ultimate results, even when discectomy is ultimately needed for radiculopathy. Every 10 years something promising arises, but over utilization of inclusion criteria, over utilization, and the technical aspects of delivery has historically stymied every attempt since I have been in practice from 1970. Now, intradiscal therapy and biologics is the next potential “holy grail”. My suggestion is that each new therapy come with a money back guarantee if the chosen therapy does not get the results anticipated. that will level the plaint field. No one gets 100% results with no complications, but if the practioner warranties his recommended procedure, insistence on scientific validation, while desired, may be one solution for the new technologies end countered. Open access Journals will hopefully help get information to scientists more rapidly and make publications less susceptible to the business and politics health care.

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