Safe Orthopaedics reported positive outcomes from a clinical study of their sterile implants.
There were 45 patients in the retrospective clinical study. Here are five things to know about the study:
1. Gregory Lanford, MD, a neurosurgeon at St. Thomas Hospital for Specialty Surgery in Nashville, Tenn., performed the procedures. He performed instrumented lumbar fusion via an open percutaneous approach using the company's SteriSpine kits.
2. The patients underwent radiograph follow-ups at one, three, six and 12 months after surgery. There weren't any cases of infection in the patients.
3. None of the patients reported morbidity or mortality. The infection rate for instrumented lumbar fusion commonly found in the literature is 3 percent to 6 percent, peaking at two weeks post-op.
4. The Safe Orthopaedics technology is designed to reduce the risk of infections and avoid instrument sterilization. The process also limits hospital costs.
5. SteriSpine is FDA-approved and has been marketed in 12 countries, including the United States and Europe. There were almost 1,000 procedures performed in 2014 using the technology, and already in the first half of 2015 there have been 1,143 procedures.