X-Bolt Orhopaedics Lts
Fractures constitute a heavy socioeconomic burden worldwide. The cost of this clinical problem is estimated at 1.75 million disability adjusted life years lost, 1.4% of the total healthcare burden in established market economies. Sliding hip screw fixation (SHS) is well established in the treatment of extracapsular fractures. However, in some hip fractures there is deficient bone to share load with the fixation device leading to failure of the fixation. Revision surgery, to either re-fix or replace the proximal femur is complex and the outcomes are poor in this frail group of patients. The X-Bolt Dynamic Plating system (XHS) builds on the successful design features of the SHS but differs in the nature of the fixation in the head. Expanding flanges are deployed to engage and compress the surrounding cancellous bone improving fixation. The use of the X-Bolt XHS has increased over the past few years - with an increasing number of trusts in the UK offering this treatment as standard of care.
The WHiTE Four Trial aims to quantify and draw inference on observed differences in participant's heath status between the trial treatment groups (Sliding Hip Screw & X-Bolt Hip system) at 4 months post-surgery, as well as in differences in the risk of all cause revision surgery and in complications at 4- and 12-months post-surgery.
04 January 2021
Study results published in BJJ. There was no statistically significant difference in the health-related quality of life at four and 12 months between X-bolt Dynamic Plating System and the sliding hip screw
29 May 2019 Final Data Lock and Analysis
The database is now locked for analysis, results wil be available soon!
23 January 2019- One-year follow-up in 1000th patient
One-year follow-up in 1000th patient is completed today. The Company’s X-BOLT® innovative hip fracture device was also granted FDA 510k approval for marketing in the United States in Q4 2018- read here
13 June 2018- Data collection update
Well done research teams in Southmead Hospital, Wexham Park hospital, Royal infirmary Leicester and John Radcliffe Hospital for completing all your Baseline CRFs!
26 March 2018: Wexham Park Hospital, Royal Victoria Infirmary Newcastle, University Hospital Coventry and Warwickshire- well done!
All sites have received their own recruitment targets for March- Wexham Park and Royal Victoria Infirmary Newcastle, University Hospital Coventry and Warwickshire have reached theirs- thank you all!
23 March 2018 : 1100 participants!
Only 28 randomisations until end of recruitment!
15 February 2018: Getting close - Less than 100 patients to go!
1053 participants recruited to date. Getting so close to the target of 1128!
18 January 2018: 1000th participant randomised by Leicester Royal Infirmary!
Keep up the good work, we're nearly there- 128 participants to go!
21 December 2017: Special Prize to the team who randomises 1000th participant before 2018
Just 37 more patients are required to get 1000 participants!
19 November 2017: 900th participant recruited! Royal Victoria Infirmary, Newcastle have just recruited 900th participant into WHITE Four! Well done, team!
02 October 2017: 800th participant recruited! The research staff at Royal Victoria Infirmary recruited our 800th participant yesterday. Thank you all for your hard work with screening and recruitment of participants to WHiTE Four!
25 September 2017 Teleconference
We will be holding a teleconference for all participating sites for sharing their experiences and concerns about the trial. We'll discuss how to optimise general trial procedures ( screening, consent process, data collection) with the focus on recruitment. For further details, please email firstname.lastname@example.org
August 2017 Top Recruiter: Coventry and Warwickshire University Hospitals. Thumbs up to the team in Coventry for recruiting 8 patients to WHiTE 4 trial in August!
July 2017 Top Recruiter: Southmead Hospital, Bristol.Well done for recruiting 9 patients, Southmead team!
24 July 2017: 700th participant! Congratulations to Queen Alexandra Hospital, Portsmouth for recruiting the 700th WHiTE Four patient today! Many thanks and keep up the good work!
11 April 2017: 500th participant! Congratulations to Wexham Park for recruiting the 500th WHiTE Four patient today, and many thanks to all research staff for your efforts.
31 March 2017: HALFWAY THERE.... Coventry recruited our 482nd participant today, which brought us to our halfway point for the trial, and Northumbria took us over the halfway point on April 4th with participant 483. It's all downhill from here..!
21 February 2017: 400th participant recruited! The research staff at Royal Victoria Infirmary recruited our 40th participant today. Thank you all for your hard work with screening and recruitment of participants to WHiTE Four!
31 January 2017: TOP Recruiters for January = Northumbria (19 participants). This is the highest monthly recruitment number (75) since WHiTE Four opened for recruitment in June 2016. Thank you to the NSE research team for all of your hard work!
10 January 2017: The John Radcliffe Hospital recruited our 300th participant!
06 January 2017: Queen Alexandra Hospital, Portsmouth, joins the WHiTE Four team
31 December 2016: TOP Recruiters for December = Oxford (16 participants)
30 November 2016: TOP Recruiters for November = Oxford (12 participants)
18 November 2016: The 200th patient has now been recruited to WHiTE Four at NSECH!
31 October 2016: TOP Recruiters for October = Oxford (12 participants)
13 October 2016: Leicester Royal Infirmary has joined the WHiTE Four team!
30 September 2016: TOP Recruiters for September = Coventry (12 participants)
30 September 2016: Wexham Park Hospital is open for recruitment.
16 September 2016: Frimley Park Hospital is open for recruitment.
14 September 2016: The 100th WHiTE Four patient has been recruited by University Hospital Coventry!
31 August 2016: TOP Recruiters for August = Oxford (JR Hospital - 11 participants)
23 August 2016: Royal Victoria Informary (Newcastle-Upon-Tyne) is now open to recruitment.
31 July 2016: TOP Recruiters for July = Coventry (15 participants)
30 June 2016: TOP Recruiters for June = Northumbria (8 participants)
27 June 2016: James Cook University Hospital (Middlesborough) and Southmead Hospital Bristol have started recruiting for WHiTE Four.
21 June 2016: University Hospital Coventry has begun recruiting WHiTE Four participants.
16 June 2016: The John Radcliffe Hospital is now open to recruitment.
15 June 2016: First site goes live for the WHiTE 4 Study! Northumbria Specialist Emergency Care Hospital, in Cramlington near Newcastle-Upon-Tyne, is now open to recruitment.