Minimus Spine has enrolled the 30th subject into its 50-patient randomised study comparing Triojection; a system intended to facilitate the treatment of disc herniations with an intradiscal injection of ozone gas to discectomy.
Bruce Frankel, professor of Neurosurgery at the Medical University of South Carolina and co-director of the MUSC Spine Center (both Charleston, USA), says, “Triojection has the potential to significantly impact the treatment of patients with disc herniations. The benefits of epidural steroid injections are limited and the injections simply do not work for everyone. Discectomy is the gold standard for patients that have not responded to epidural injections or want more immediate benefit. If Triojection can offer a comparable outcome to surgery, then I envision it being used routinely before considering surgery. Triojection would be more attractive to patients and significantly reduce the cost of care. I am looking forward to the results from this study.”
The study is listed on clinicaltrials.gov under identifier NCT02525120. Patients with a confirmed disc herniation and significant leg pain lasting more than 6 weeks are being presented with the option to enroll in the study. Upon consent, patients are randomised in a 1:1 ratio between Triojection and discectomy. The primary outcome is non-inferiority of Triojection to discectomy surgery for improvement in leg pain over six month following treatment. Back pain, disability and other outcomes are also being collected. While the primary endpoint is based on data up to and including six months, Minimus Spine is following these patients for two years. Clinical sites are in Italy, Switzerland and Greece.