X-Bolt Orthopaedics announced that the 1,000th patient has completed one-year follow-up in WHITE4, a randomized controlled trial comparing the X-BOLT® expanding bolt device vs. a sliding hip screw (SHS), the current standard of care in hip fracture treatment.
At 1,140 subjects, this is the largest-ever trial comparing extracapsular hip fracture fixation devices.
WHITE4, which stands for World Hip Trauma Evaluation, follows Warwick Hip Trauma Evaluation One, a 100-patient trial that also compared X-Bolt to the SHS. WHITE1demonstrated a 0% re-operation rate with the X-BOLT device, as opposed to 6% for the SHS.
Results from WHITE4 are expected in June.
In 4Q18, X-Bolt Orthopaedics received FDA 510(k) clearance to market its X-BOLT Hip Nailing and Hip Plating fixation systems.
Sources: X-Bolt Orthopaedics; ORTHOWORLD, Inc. *Image courtesy of X-Bolt Orthopaedics