Expanding Orthopedics Inc., a leading company in the area of expanding orthopedics devices, announced today that it has started to enroll patients in Germany for its multi-center post-market study to evaluate the performance and usability of the XPED Expanding Pedicle Screw System[TM]. Up to 50 patients will be enrolled in this multi-center study and will be followed for up to 24 months using pain and quality-of-life questionnaires as well as radiographic assessments. Screw loosening is a frequent complication associated with pedicle screw fixation in weak bone and can lead to a revision surgical treatment. The unique XPED Expanding Pedicle Screw System has been designed to offer improved anchoring of the implant in the vertebral body.
Dr. Klassen, the Principal Investigator of the study and Head of the Spine Surgery and Neuro Traumatology Department at the St. Bonifatius Hospital, Lingen, Germany, said that "the study is designed to gather clinical data using the XPED System across a wide range of patients. These patients typically require enhanced anchoring solutions to obtain sustainable long-term stability of the spine." Dr. Klassen added that "today we are using cement to augment pedicle screw fixation in weak bone but believe that using the XPED will be safer and more efficient to treat our patients." Dr. Klassen concluded "we already enrolled 4 patients and believe to finish enrolling our 20 patients within 6 months. All patients will be followed-up for 24 months."