Welcome to the White8 trial website
BACKGROUND
Fragility hip fractures present a significant global challenge to patients, clinicians and healthcare systems. The global literature confirms an overall mortality risk in the range 10-40% in the first year with much of this attributed to post-operative complications.
Surgical site infection (SSI) is a significant complication with literature for hemiarthroplasty infection stating rates as high as 7.3%. Therefore, the prevention of postoperative complications is likely to be one good way of reducing mortality in this group of patients.
Perioperative antibiotics are one proven means of reducing postoperative infection in patients undergoing hip arthroplasty for any indication. The current standard for cemented hip hemiarthroplasty is the use of parenteral antibiotics in combination with antibiotic loaded cement.
TRIAL DESIGN
This will be multi centre, multi-surgeon, parallel, two arm, randomised controlled trial. This will be embedded in the World Hip Trauma Evaluation (WHITE) comprehensive cohort.
All adult patients 60 years of age and over presenting at the trial centres, who in the opinion of the treating surgeon require acute surgical treatment with a cemented hip hemiarthroplasty are eligible for inclusion.
AIM
The aim of this pragmatic randomised controlled trial is to determine the rate of deep infection in patients treated with either low dose single antibiotic loaded cement or high dose dual antibiotic loaded cement for the treatment of hip fracture with a hemi-arthroplasty.
This study is sponsored by the Northumbria Heathcare NHS Foundation Trust, and is funded by Heraeus Medical. The trial is managed by Oxford Trauma, at the University of Oxford.
03 July 2020
Queen Alexandra Hosital team re-started recruitment & screening for the WHiTE8 Copal trial !
03 July 2020
The July 2020 newsletter is ready for the site teams to read.
01 July 2020
Leicester Royal Infirmary Hospital team were top recruiters for the WHiTE8 Copal trial in June 2020.Site team has recruited 13 patients for the WHiTE8 Copal trial.
30 June 2020
John Radcliffe Hospital team re-started recruitment & screening for the WHiTE8 Copal trial !
29 Jun 2020
Poole Hospital team restarted a recruitment and screening for the WHiTE8 COPAL trial !
16 June 2020
Today the Leicester Royal Infirmary Hospital team recruited a first study partcipant since recruitment for the WHiTE8 Copal trial was paused due to the COVID-19 pandemic.
16 June 2020
Royal Cornwall Hospital team restarted a recruitment and screening for the WHiTE8 COPAL trial !
15 June 2020
Leicester Royal Infirmary Hospital team restarted a recruitment and screening for the WHiTE8 COPAL trial !
11 June 2020
The June 2020 newsletter is ready for the site teams to read
03 June 2020
Kings College Hospital restarted recruitment and screening for the WHiTE8 COPAL trial!
27 May 2020
The Trial Managment Group made a decission to restart recruitment and screenig activities for the WHiTE8 COPAL trial
20 May 2020
Happy International Clinical Trial Day!
15 April 2020
The April 2020 newsletter is ready for the site teams to read
08 April 2020
In March 2020 the James Cook Hospital were top recruiters for the WHiTE8 Copal trial and have recruited 13 participants.
22 March 2020
Temporary suspension of recruitment and screening activities due to current COVID-19 pandemic as of 5pm on Sunday 22nd of March 2020 until further notice.
11 March 2020
The March 2020 newsletter is ready for the site teams to read.
05 March 2020
The Northumbria Specialist Emergency Care Hospital (NSE) has resumed recruitment for the WHiTE8 Copal trial. Welcome back!
04 March 2020
In February 2020 the Leicester Royal Infirmary were top recruiters for the WHITE 8 Copal trial and have recruited 15 study partcipants.
14 February 2020
The February 2020 newsletter is ready for site teams to read
06 February 2020
In January 2020 the Leicester Royal Infirmary were top recruiters for the WHITE 8 Copal trial and have recruited 22 study subjects.
13 January 2020
The January newsletter is ready for site teams to read
06 January 2020
In December 2019 the Leicester Royal Infirmary were top recruiters for the WHITE 8 Copal trial and have recruited 23 study subjects.
01 January 2020
We have now reached 3000th study partcipant recruited to the WHiTE 8 Copal trial.
We would like to thank all the site teams for their efforts with consenting and recruiting participants to the study!
25 December 2019 to 02 January 2020
Our trial office will be closed during the festive holiday period, however we will still be monitoring our mailboxes, so if you have any urgent queries, please email the trial mailbox and mark the email as 'urgent' in the subject. Happy Festive Holidays to all of our participating sites!
16 December 2019
The WHITE 8 study team has now a Twitter account. Follow us @8Copal for latest news and trial updates
10 December 2019
The December newsletter is ready for site teams to read
01 December 2019
Royal Cornwall Hospital were top recruiters for the WHITE 8 trial in November 2019. Site team has recruited 19 patients for the WHITE 8 trial.
29 July 2019 - We have now reached our 2000th participant recruited to the WHiTE 8 trial. The 2000th participant ID (W8-12000) was randomised by Royal Berkshire Hospital, however technically, this is not the 2000th participant as we have had several randomisation errors. The 2000th participant was actually W8-12010, who was randomised by Southmead Hospital. Regardless, it's been another busy day of recruits and we thank all teams for their efforts with consenting and recruiting participants to the study!
24 June 2019 - Welcome to Mr Teivendran and his team who have now opened for recruitment for the WHiTE 8 study.
06 June 2019 - Luton and Dunstable have now joined the WHiTE team, both for the Cohort and for WHiTE 8. Welcome to Mr Kalairajah and his team.
01 June 2019 - The June newsletter is ready for sites to read
15 May 2019 - We have now reached 1,500 participants recruited to the WHiTE 8 Study!
01 May 2019 - See the following link for the May Newsletter
24 April 2019 - Welcome to Ben Rogers and his team at Royal Sussex County Hospital who opened for recruitmet today.
01 April 2019 - The April Newsletter is now available for you to read
29 March 2019 - Queen Elizabeth Hospital are the latest team to open for recruitment for WHiTE 8. Welcome to Mr Mahmood and his team!
01 March 2019 - 1000 PATIENTS!! You have now helped us to recruit 1000 participants to the WHiTE 8 Copal trial. Southmead were the lucky site to recruit W8-11000. We are very grateful to all of you for your hard work with screening, consenting & recruiting patients to this study, and for your diligence with sending us the related documents and data. See here for the March Newsletter
20 February 2019 - Welcome to Morriston Hospital (Ian Pallister & team) who have opened for recruitment to the WHiTE 8 trial. We're looking forward to seeing your first recruit!
12 February 2019 - The February issue of the WHiTE 8 Newsletter is now available. Let us know if you have anything you'd like to see added to the newsletter (e.g. tips to share, issues you'd like help with, etc).
08 February 2019 - We've set up some teleconferences with sites to discuss common issues and to share good practice across our research sites. Stay tuned for an email inviting your team to join us at one of the scheduled teleconference sessions.
23 January 2019 - With a bit of delay, see the link included here for the January issue of the WHiTE 8 newsletter.
10 January 2019 - A warm New Year's welcome to Ipswich Hospital who have opened for recruitment to the WHiTE study today. We're happy to have Chris Roberts and his research staff join the WHiTE team.
24 December 2018 to 04 January 2019 - Our trial office will be closed during the holiday period, however we will still be monitoring our mailboxes, so if you have any urgent queries, please email the trial mailbox and mark the email as 'urgent' in the subject. Happy Holidays to all of our participating sites!
Key paper - The use of high-dose dual-impregnated antibiotic-laden cement with hemiarthroplasy... Bone Joint J. 2016 Nov; 98-B(11): 1534–1541.
