Largest Ever Hip Fracture Fixation Trial in Over 1,000 Patients Demonstrates Unprecedently Low Cut-Out Rates for X-BOLT® Device

DUBLIN, Sept. 13, 2019 /PRNewswire/ -- X-BOLT Orthopaedics, a leading medical device company, today announced preliminary results from the largest ever multi-centre randomised controlled trial comparing extracapsular hip fracture fixation devices, known as World Hip Trauma Evaluation 4 (WHITE4). The trial was conducted by Oxford University and supported by NIHR Oxford Biomedical Research Centre.

X-Bolt is the first and only company to have conducted such rigorous clinical testing prior to commercial launch of its X-BOLT® hip fixture device. The headline results, presented at the British Orthopaedic Association in Liverpool yesterday, demonstrated the lowest ever 'cut-out' rate for a hip fixation device, achieving just 0.8% in a population of 476 patients. The study also showed that the X-BOLT® device performed as well as the hip sliding screw (SHS) device with respect to EuroQol 5 Dimension Score (EQ-5D), a validated measure of health-related quality of life, as well as patient mortality, residential status, revision surgery and radiographic measures.

A 100-patient randomised pilot study published in 2016, known as 'WHITE1' at the University of Warwick showed a zero (0%) re-operation rate with the X-BOLT® device, versus a 6% reoperation rate with the sliding hip screw in unstable intertrochanteric hip fractures (Bone and Joint Journal 2016; 98-B: 686-9).

'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 treatment costs.  X-BOLT's simple yet innovative mechanism for anchorage to the bone utilises wings that expand in situ to offer a rotationally stronger and more secure femoral bone anchorage than traditional screw fixation.

Recruitment for WHITE4 commenced in June 2016 and involved over 1000 patients in 10 centres throughout the UK, collaborating with the Orthopaedic Trauma Society, including Oxford, Northumbria, Leicester, Newcastle, South Tees, Frimley Park, Wexham, Coventry, Bristol and Portsmouth. Patients were randomised 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 weeks, 4 months and one year following surgery.

Dr. Brian Thornes, CEO of X-BOLT Orthopaedics said, "We are delighted that the X-BOLT has been so thoroughly investigated in such high quality independent research as the WHITE1 and WHITE 4 trials showing the lowest cut-out rates of any device on the market, mirroring its proven superior performance in biomechanical testing. Given the high volume of hip fractures and an ever-aging population, the X-BOLT is set to revolutionise hip fracture fixation."

Professor Griffin, Chief Investigator for WHITE 4, based at Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford said, "WHITE 4 was a highly successful trial which has set the benchmark for the entry of orthopaedic devices into clinical practice. I have been delighted to work with X-BOLT Orthopaedics over a number of years to provide outstanding quality research around the use of this device. It sets the best of standards for other companies to aspire to, particularly with a view towards the new regulations for devices coming into force in Europe early next year."

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. Loss of mobility and independence among hip fracture survivors is profound; less than 50% regaining their previous function and 33% being totally dependent or in a nursing home a year later. Reoperations occur in about 3-6% 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.

About X-BOLT Orthopaedics

X-BOLT® Orthopaedics is an Irish medical device company, that has designed and developed a highly innovative and unique range of hip nailing and plating solutions suitable for all hip fractures that require fixation. The X-BOLT® ("Expanding Bolt") hip fixation system significantly improves anchorage in osteoporotic bone and reduces the requirement for costly repeat surgeries, as well as allowing greater confidence to mobile fully weight bearing post operation.X-BOLT® has strong scientific evidence via extensive clinical trials and has received European CE Mark from the British Standards Institute (BSI) and FDA 510k approval for marketing in Europe and the US.

Founded and led by Dr. Brian Thornes, an experienced orthopaedic surgeon with extensive development experience having previously invented, developed and licensed the ankle syndesmosis "TightRope" device to Arthrex, Inc (Naples, FL) in 2003. To date, over 350,000 Tightropes have been implanted worldwide, with many top football and rugby professionals amongst its recipients. Recently published multicentre clinical trials have shown that the Tightrope has set the new gold standard for ankle syndesmosis injuries.

The X-BOLT device can be manufactured in stainless steel or titanium and is also adaptable for other areas of osteoporotic fixation such as the spine.

The National Institute for Health Research (NIHR) Oxford Biomedical Research Centre (BRC) 

NIHR Oxford Biomedical Research Centre (BRC) is based at the Oxford University Hospitals NHS Foundation Trust and run in partnership with the University of Oxford. The NIHR is the nation's largest funder of health and care research. The NIHR:

• Funds, supports and delivers high quality research that benefits the NHS, public health and social care
• Engages and involves patients, carers and the public in order to improve the reach, quality and impact of research
• Attracts, trains and supports the best researchers to tackle the complex health and care challenges of the future
• Invests in world-class infrastructure and a skilled delivery workforce to translate discoveries into improved treatments and services
• Partners with other public funders, charities and industry to maximise the value of research to patients and the economy

The NIHR was established in 2006 to improve the health and wealth of the nation through research, and is funded by the Department of Health and Social Care. In addition to its national role, the NIHR commissions applied health research to benefit the poorest people in low- and middle-income countries, using Official Development Assistance funding.

This work uses data provided by patients and collected by the NHS as part of their care and support and would not have been possible without access to this data. The NIHR recognises and values the role of patient data, securely accessed and stored, both in underpinning and leading to improvements in research and care. www.nihr.ac.uk/patientdata

The Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences (NDORMS)

NDORMS is a multi-disciplinary department focusing on discovering the causes of musculoskeletal and inflammatory conditions to deliver excellent and innovative care that improves people's quality of life. The largest European academic department in its field, NDORMS is part of the Medical Sciences Division of the University of Oxford, and is a rapidly growing community of more than 400 orthopaedic surgeons, rheumatologists and scientists all working in the field of musculoskeletal disorders.

The research work of the department takes place in several locations across the Nuffield Orthopaedic Centre, namely the Botnar Research Centre, and the Kennedy Institute of Rheumatology. The co-location with NHS services puts the department in an excellent position with basic researchers working alongside clinicians. This substantially improves research capacity, improving access for researchers to patients, and facilitating the interaction between clinicians and scientists that is essential for successful medical research. www.ndorms.ox.ac.uk

Contact information:

X-BOLT
Brian Thornes, CEO
brian.thornes@x-bolt.com

Katja Stout, Scius Communications
katja@sciuscommunications.com