Expanding Orthopedics has announced that it is starting to enrol patients in Germany for its multicentre postmarket study to evaluate the performance and usability of its XPED expanding pedicle screw system.
A company press release explained that up to 50 patients will be enrolled in the multicentre study and that these patients will be followed for up to 24 months using pain and quality-of-life questionnaires as well as radiographic assessments. According to the press release, the unique XPED expanding pedicle screw system has been designed to offer improved anchoring of the implant in the vertebral body.
Douglas 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: “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.” He 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. We already enrolled four patients and believe to finish enrolling our 20 patients within six months. All patients will be followed-up for 24 months.”
“We are delighted to begin this study and are excited to have the opportunity to work with the professional and skilled team of Dr Klassen who has successfully lead major international clinical studies in the past years,” said Ofer Bokobza, chief executive officer of Expanding Orthopedics.