Expanding Orthopedics Inc. has begun a new clinical study in Germany to evaluate its Xped expanding pedicle screw system. 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. Xped was developed because screw loosening is a frequent complication associated with pedicle screw fixation in weak bone and can lead to a revision surgical treatment; and there was a need for a screw that can anchor better in the vertebral body.
“The study is designed to gather clinical data using the Xped System across a wide range of patients,” said Peter Douglas Klassen, M.D., the principal investigator of the study and head of the spine surgery and neuro traumatology department at St. Bonifatius Hospital, Lingen, Germany. “These patients typically require enhanced anchoring solutions to obtain sustainable long-term stability of the spine. 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.”
Four patients have already been enrolled, according to Klassen, and he aims to complete enrollment with 20 patients within six months. The patients will then 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, CEO of Expanding Orthopedics. “The Xped system, the first product from our expanding device technology platform, is commercially available in Europe and our earliest patients have now reached the two-year follow-up milestone with very encouraging results.”
Despite the Xped being on the European market already, Bokobza explained that the study is intended to open doors for the device to be used “standard of care in Europe.” It is currently being used as a treatment option for patients with compromised bone.
Expanding Orthopedics is based in Or Akiva, Israel.