Largest Ever Trial in Hip Fracture Fixation Completes One-Year Follow-Up

X-Bolt Orthopaedics today announced the 1000th patient has completed one-year of follow-up in the (n= 1,140 patients) multi-center randomized controlled trial comparing extracapsular hip fracture fixation devices, known as World Hip Trauma Evaluation 4 (WHITE4), conducted by Oxford University and supported by NIHR Oxford Biomedical Research Centre. The Company’s X-BOLT innovative hip fracture device was also granted FDA 510(k) approval for marketing in the United States in Q4 2018.
 
Addressing the growing socio-economic problems of treating hip fractures in frail elderly patients, X-BOLT is designed to revolutionize current surgical treatment and significantly reduce re-operation rates. Most clinical complications occur with anchorage in the osteoporotic bone and X-BOLT offers an innovative mechanism that uses wings that expand in situ to offer a rotationally stronger and more secure femoral bone anchorage than traditional screw fixation. A stronger leg to stand on post-surgery allows for faster, fuller and more confident mobilization of the patient.
 
Recruitment for WHITE4 commenced in June 2016 and involved 10 centers in the UK, collaborating with the Orthopaedic Trauma Society (GB&I), including Oxford, Northumbria, Leicester, Newcastle, South Tees, Frimley Park, Wexham, Coventry, Bristol, and Portsmouth. Results are expected to be available in June 2019. Patients were randomized at the time of surgery to receive either a gold standard sliding hip screw (SHS) device or X-BOLT. Follow-up for all patients occurred at baseline, 4 months and one year following surgery.
 
Outcome measurements in WHITE4 include the EuroQol 5 Dimension Score (EQ-5D-5L), a validated measure of health-related quality of life, as well as patient mortality, residential status, revision surgery, and radiographic measures. This study is a fully powered superiority study that may definitively show the X-BOLT clinically to be the new gold standard femoral head fixation in hip fracture fixation.
 
A 100-patient randomized pilot study published in 2016, known as ‘WHITE1’ at the University of Warwick showed a zero (0 percent) re-operation rate with the X-BOLT device, versus a 6 percent reoperation rate with the traditional sliding hip screw (SHS) in unstable intertrochanteric hip fractures. Full results of WHITE1 are published in the Bone Joint Journal 2016; 98-B: 686-9.
 
Professor Xavier Griffin, the Chief Investigator of the WHITE 4 trial at Oxford Trauma, commented on the trial, “This is the largest randomized clinical trial in the field of hip fracture fixation and we are delighted to have hit this significant milestone. X-Bolt should be congratulated as an exemplary company for their commitment to working with us using the IDEAL framework in delivering this novel device to market. We look forward to communicating the full results of the trial in June 2019.”
 
Dr. Brian Thornes, CEO of X-BOLT Orthopaedics said, “Hip fractures in the very elderly are a growing unmet medical need with current surgical procedures resulting in poor outcomes that often result in a loss of mobility and independence in the vulnerable group of patients. Hip fracture fixation has lacked any significant innovation since Sir John Charnley patented the sliding hip screw in 1955. We believe that the X-BOLT device has the potential to transform fixation in patients suffering from osteoporosis and hip fractures, providing a significant improvement in mobility and quality of life.”
 
Approximately 1.6 million hip fractures occur worldwide each year and due to an aging population, it is expected this number could reach 6 million by 2050. Each hip fracture episode costs approximately $40,000 (£30,000) in health and social costs. 70 percent of hip fractures occur in women with a median age of 81yrs. Loss of mobility and independence among hip fracture survivors is profound; less than 50 percent regaining their previous function and 33 percent being totally dependent or in a nursing home a year later. Reoperations occur in 6 percent of patients, resulting in additional costs of approximately $50,000 (£35,000). Reducing the re-operation rate provides a significant opportunity for hospitals and governments to greatly reduce 30-day readmissions and overall healthcare costs, notwithstanding the benefits to patients by improving their quality of life.
 
The X-BOLT hip fracture nailing and plating systems were also recently granted FDA 510k approval in Q4 2018, having undergone rigorous mechanical and biocompatibility testing, along with interactions with the US Food and Drug Administration since 2013. This FDA approval now permits the marketing and commercialization of the X-BOLT in the United States.