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Expanding Orthopedics launches a multi-center clinical study in Europe using the XPED Pedicle Screw System
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Expanding Orthopedics Inc. announced in a press release that it has launched a post-market, prospective study in Europe, assessing the performance and usability of the company’s XPED Expanding Pedicle Screw System for spinal fusion.
According to the release, up to 50 patients will be enrolled in the multi-center study and will be followed for up to 24 months postimplantation using quality-of-life questionnaires and radiographic assessments. The spine team of the Stauferklinikum in Germany is leading the study, the release noted, with other centers due to join in the coming months.
The XPED Pedicle Screw System is a complete spinal implant system including both standard and expandable pedicle screws as well as all necessary instrumentation. According to the release, the XPED system is designed to provide greater fixation in various bone conditions as an adjunct to spinal fusion of the thoracic, lumbar and/or sacral spine. The XPED expandable screw’s four-wing design reportedly increases the contact area with the bone, thus facilitating improved bone anchoring. This design allows for natural bone in-growth process which provides secondary natural fixation. The XPED Pedicle Screw System is CE marked and commercially available across Europe.
"Initial anchoring and long-term fixation of the pedicle screw within the vertebral body are crucial for successful spinal fusion,” Ronald Rissel, MD, Head of Spine Center, Stauferklinikum, Mutlangen, Germany, stated in the release. "A growing number of our patients undergoing spine fusion surgery suffer from an impaired bone condition as a result of chronic diseases, an unhealthy lifestyle and aging spine. In these patients, standard pedicle screws are suboptimal, leading to a higher risk of screw loosening and resulting in a high re-operation rate. I expect the XPED expandable screw's innovative design to provide enhanced anchoring and potentially improve patient outcome."