Minimus Spine Enrolls 30th Subject to Study Triojection vs Discectomy

It’s a milestone for Minimus Spine, makers of the Triojection System. The company has enrolled its 30th participant into its 50-patient randomized study comparing Triojection to discectomy.

According to the November 14, 2016 news release, Triojection System is “a novel system intended to facilitate the treatment of disc herniations with an intradiscal injection of ozone gas…”

“Patients with a confirmed disc herniation and significant leg pain lasting more than 6 [six] weeks are being presented with the option to enroll in the study. Upon consent, patients are randomized 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.”

“This is the first study to randomize patients between an intradiscal ozone injection and surgery. Hitting this enrollment milestone puts Minimus in position to complete enrollment by September of next year, resulting in primary endpoint data completed near the end of Q1-2018, ” said David Hooper, Ph.D., Minimus Spine’s Chief Executive Officer. “Triojection already has CE Mark, and if the product demonstrates comparable outcomes to surgery, Minimus will be well-positioned to expand launch activities in Europe. We recognize that new products must be supported with rigorous clinical data to justify their cost. There are no short cuts and that is why we have been pro-actively investing in this study.”

Dr. Hooper told OTW, “Based on the literature, Triojection may be a successful treatment for 75-80% of disc herniation patients that would otherwise have surgery. Discectomy is generally regarded as a good operation but not everyone improves, there is a post-operative recovery period, and there are risks. Many patients are extremely reluctant to even consider spine surgery. If Triojection can avoid or even significantly delay a discectomy, it would be good for patients and reduce costs. If a patient does not respond to Triojection, the surgical option is still readily available.”

“This Triojection study is the first to compare an intradiscal ozone injection directly to surgery. What has been our greatest enrollment challenge? Without doubt, it’s the randomization to surgery. However, this greatly reduces the likelihood that patients would improve with continued conservative care or the passage of time. These patients have been in pain for at least six weeks and are ready for surgery now. If the study were not randomized, it would accrue much faster but the results would be less informative. Our goal has been to make this the most rigorous study possible and we believe this is the right study design for Triojection. We continue to consider additional sites in Europe and invite interested sites to contact us.”