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Advantages of Safe Orthopaedics sterile single-use instrumentation for lumbar fusion confirmed in US clinical study

Safe Orthopaedics, a company developing and marketing an innovative range of sterile implants combined with their single-use surgical instruments, announces the positive outcomes of a retrospective clinical study carried out by Dr. Gregory Lanford, neurosurgeon at St.Thomas Hospital for Specialty Surgery, Nashville, TN.

Dr. Lanford said: "Safe Orthopaedics’ Sterispine is a cost-effective system that negates the need for sterilization and potentially lowers the infection rate by mitigating risks for cross-contamination. The instruments are easy to use by any surgeon experienced in pedicle screw fixation."

A total of 45 patients were operated on completing an instrumented lumbar fusion via an open or percutaneous approach using Sterispine kits by the author between July of 2013 and January of 2015. A 3 to 12 months follow-up period has been performed for each patient with plain radiograph at 1, 3, 6 and 12 months.

No cases of infection nor morbidity or mortality were reported while the infection rate for instrumented lumbar fusion is commonly found in the literature at 3-6% with a peak at two weeks post-op.

Tim Nye, Safe Orthopaedics US Vice President, added: "This study is an important milestone as it highlights the potential benefits of using Safe Orthopaedics products. We are very thankful to Dr. Lanford for this important work."

Founded in 2010, Safe Orthopaedics is a French medical technology company that develops and markets an innovative range of sterile implants and associated single-use surgical instruments, with the aim of facilitating safer, optimized and lower-cost spinal surgery.

By avoiding the reuse of surgical instruments, Safe Orthopaedics reduces the risk of infection, avoids the cumbersome and unreliable logistics of instrument sterilization, and limits hospital costs. Protected by 17 patent families, the company’s CE-marked and FDA-approved SteriSpineTM kits are already being marketed in 12 countries, in Europe and the US..