Preliminary study results indicate that the X-BOLT® expanding bolt device for fracture repair demonstrated a cut-out rate of 0.8% in a population of 476 patients, and performed as well as a sliding hip screw (SHS) in measures such as quality of life, mortality, residential status, revision, and radiographic measures.
World Hip Trauma Evaluation 4 (WHITE4) is the largest ever multi-center randomized controlled trial comparing extracapsular hip fracture fixation devices. It was conducted by Oxford University and supported by the NIHR Oxford Biomedical Research Centre. Recruitment of over 1,000 patients at 10 centers in the U.K. began in June 2016, with patients receiving either an SHS or X-BOLT. Follow-up occurred at baseline, four weeks, four months and one year.
WHITE1, an earlier 100-patient randomized pilot study, showed a 0% re-operation rate with X-BOLT vs. 5% rate with the SHS in unstable intertrochanteric hip fractures.
Cut-out is a failure of implant anchorage which causes the implant or screw to literally "cut-out" of the bone and into the hip joint. Fixation failure due to cut-out is the main cause of re-operation, resulting in increased hospital costs. X-BOLT's anchor mechanism employs wings that expand in situ to offer a rotationally stronger and more secure femoral bone anchorage than traditional screw fixation.
X-BOLT is approved under the CE Mark and received FDA 510(k) market clearance. It can be manufactured in stainless steel or titanium and is adaptable for other areas of osteoporotic fixation, such as the spine.
Source: X-BOLT Orthopaedics