X-Bolt Orthopaedics highlights key results data from the WHITE4 trial, published in February’s Bone & Joint Journal, comparing the company’s flagship X-Bolt® XHS versus the gold standard Sliding Hip Screw. WHITE4 was the world’s largest randomised trial in hip fracture fixation (n=1,128) across ten UK specialist orthopaedic centres.
Sliding Hip Screw (SHS) fixation is a well-established treatment of trochanteric hip fractures. XHS differs only by the nature of fixation in the femoral head, using an expanding bolt instead of a lag screw.
In WHITE4, patient wellbeing outcome scores at four months were better in more than 90% of XHS versus SHS patients, rising to 95% favouring XHS when ‘crossovers’ (XHS-allocated who actually received SHS) are excluded and reference is made to baseline pre-injury scores. Reflected into clinical practice, greater than 20% of patients would tangibly perceive a health benefit with XHS versus SHS. The median age of patients was 86 years.
Reoperation rates, including femoral head ‘cut-out’ were the lowest ever recorded for a trial of this size. XHS had a 0.8% cut-out rate within a total ‘all-cause’ 2.3% reoperation rate. ‘Cut-out’ is a failure of implant anchorage that causes the lag screw to literally cut-out of the bone and into the hip joint. A 2010 Bone and Joint Journal paper from Oxford and data from almost 31,000 patients in the Norwegian Hip Fracture Register show SHS reoperation rates are between 4% and 5%, with cut-out accounting for two-thirds of these. A 2016, 100-patient clinical trial (WHITE1) showed a 0% XHS reoperation rate versus a 6% SHS cut-out and reoperation rate.
Commenting on the publication of the WHITE4 paper, X-Bolt Orthopaedics’ CEO, Dr Brian Thornes said, “This was a large trial in a very frail patient group, whose main desire is to stay out of hospital and to maintain their independence. The data confirms the outstanding safety profile of the X-Bolt, which virtually eliminates ‘cut-out’ as an issue. I am also delighted the clinical impact translates into tangibly better outcomes for a significant