Expanding Orthopedics, a spinal device company, Vin Germany for a clinical study of its XPED Expanding Pedicle Screw system.
The system, which is commercially available in Europe, is designed to provide improved anchoring of the implant in the vertebral body.
The multi-center, post-market study, which will enroll up to 50 patients to assess the performance and usability of the device, will follow patients for up to 24 months using pain and quality-of-life questionnaires as well as radiographic assessments.
St Bonifatius Hospital neuro traumatology department spine surgery head and study principal investigator Dr Klassen said the study is designed to gather clinical data using the XPED System across various patients.
"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," Klassen added.
"We already enrolled 4 patients and believe to finish enrolling our 20 patients within 6 months."
Expanding Orthopedics CEO Ofer Bokobza said the company's earliest patients using XPED system have now reached the two-year follow-up milestone with encouraging results.
"Numerous surgeons in Europe have already selected the XPED as their preferred treatment option for treating patients with compromised bone but we expect the positive results of the study to give a strong base for the broad use of the XPED as the standard of care in Europe."
