Condition category
Musculoskeletal Diseases
Date applied
17/02/2016
Date assigned
17/02/2016
Last edited
24/02/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
The majority of surgeons perform total knee replacement surgery with the aid of a tourniquet. The tourniquet interrupts the blood supply and drainage from the leg and helps to create a bloodless area for the surgery to take place. A tourniquet may however increase a patients’ risk of developing a blood clot. At the end of surgery the tourniquet is deflated and blood clots that may have accumulated in the leg are immediately free to flow (embolise) within the blood stream. In some cases, blood clots and debris can return to the heart where they are then free to travel to the brain. This risk has never been examined with any definitive clinical study and it’s not known if such a study would even be feasible. This is what this study is investigating.

Who can participate?
Adults about to have a total knee replacement at University Hospitals Coventry and Warwickshire NHS trust.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group 1 have their total knee replacement surgery with a tourniquet. Those in group 2 have their surgery without a tourniquet. They all have a magnetic resonance (MR) imaging scan of their brain before having surgery and afterwards to look for evidence of clots and debris in the brain. Some participants and surgeons taking part in the study are also invited to take part in an interview to discuss their views and opinions of the of the study and how acceptable they find it. Participants are also followed-up within a year of their surgery when they are asked about how much knee pain they are experiencing and the how well the replacement joint is functioning. The researchers involved in this study also collect data from an existing database of total knee replacement surgery in England and Wales (National Joint Registry-NJR) and map it to other existing databases of deaths and hospital reported blood clots.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospitals Coventry and Warwickshire NHS trust

When is the study starting and how long is it expected to run for?
January 2017 to June 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Mr Peter Wall

Trial website

Contact information

Type

Public

Primary contact

Mr Peter Wall

ORCID ID

http://orcid.org/0000-0003-3149-3373

Contact details

University of Warwick
Clinical Sciences Research Institute
Clinical Sciences Building
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

20280

Study information

Scientific title

Safety and feasibility evaluation of tourniquets for Total Knee Replacement (SAFE-TKR): A pilot feasibility study

Acronym

SAFE­-TKR

Study hypothesis

This is a pilot trial investigating whether a full randomised controlled trial comparing the risk of blood clots developing after total knee replacement (TKR) surgery for patients that have a tourniquet applied during surgery verses those that do not is feasible.

Ethics approval

West Midlands - Edgbaston Research Ethics Committee, 16/12/2015, ref: 15/WM/0455

Study design

Interventional and Observational; Design type: Treatment, Qualitative

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Musculoskeletal disorders, Surgery; Subtopic: Musculoskeletal (all Subtopics), Surgery; Disease: Elective Orthopaedic Surgery, All Surgery

Intervention

This feasibility study will comprise of three parts:
1. Patients due for TKR surgery will invited to take part in a pilot trial and randomised to surgery with or without a tourniquet with a view to recruiting 50 patients. All patients will undergo a Magnetic Resonance (MR) imaging scan of their brain before and after surgery to look for evidence of clots and debris in the brain. Other potentially important outcomes including knee pain and function within 12 months will also be collected.
2. Integrated qualitative research study. An interview study of around 30 patients and around 20 surgeons will capture the views and opinions of both groups regarding the acceptability of the pilot trial.
3. Retrospective multi-centre cohort study. A study of an existing database of TKR surgery in England and Wales (National Joint Registry-NJR) will be undertaken. The data will be mapped to other existing databases of deaths and hospital reported blood clots.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Total volume of acute brain lesions detected on Magnetic Resonance (MR) brain imaging per patient, day 1 post operatively

Secondary outcome measures

1. Montreal Cognitive Assessment (MoCA) preoperatively and day 1, 2 and 7 post operatively
2. Oxford Cognitive Screen (OCS) preoperatively and day 1, 2 and 7 post operatively
3. Mini-mental state examination (MMSE) scores preoperatively and on day 1, 2 and 7 post
operatively
4. Oxford knee score (OKS) preoperatively and at 6 and 12 months postoperatively
5. EuroQol (EQ-5D-5L) scores preoperatively and at 6 and 12 months postoperatively
6. Number of symptomatic VTE events up to 12 months postoperatively.
7. Type and frequency of all adverse and serious adverse events up to 12 months postoperatively
8. Number of intra/post-operative blood transfusions until discharge
9. Revision rate of the TKR prosthesis at 12 months
10. All cause mortality rates at 12 months

Overall trial start date

01/01/2016

Overall trial end date

31/12/2020

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients undergoing an elective primary unilateral cemented total knee replacement (TKR) under the care of four orthopaedic consultants at University Hospitals Coventry and Warwickshire (UHCW) NHS trust
2. Male and Female
3. Lower age limit 18 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 50; UK Sample Size: 50

Participant exclusion criteria

1. Patients who lack capacity under the Mental Capacity Act 2005
2. Patients for whom Magnetic Resonance (MR) imaging is either contraindicated (heart pacemaker, metallic foreign body in one or both eyes, or who have an aneurysm clip in their brain) or not feasible because of claustrophobia

Recruitment start date

01/02/2017

Recruitment end date

01/08/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Warwick
Clinical Sciences Research Institute Clinical Sciences Building Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Trial participating centre

University Hospitals Coventry and Warwickshire NHS trust
Clifford Bridge Rd
Coventry, West Midlands
CV2 2DX
United Kingdom

Sponsor information

Organisation

University of Warwick

Sponsor details

Clinical Trials Unit
Warwick Medical School
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results of this research will be disseminated to the following groups:

Patients and public. A public and patient workshop on the proposed research found consensus that the internet should be used whenever possible to disseminate the results. Led by a patient co-applicant and other PPI collaborators we will develop a study Facebook page and Twitter feed. These will track both the progress of the study and eventual results, and will allow people with an interest to have access to our findings in a contemporary and user-friendly way. Results will be presented in magazines such as Arthritis Today, and the study team will work with NHS Choices to prepare patient information for use after the pilot trial.

Medical community. A large body of specialists including nurses, physiotherapists, occupational therapists, physicians, general practitioners, anaesthetists and orthopaedic surgeons typically manage patients before, during and after TKR surgery in secondary and tertiary care centres. These groups will be targeted through conferences, seminars and meetings. All key findings from the trial will be presented at national and international conferences such as the British Orthopaedic Association (BOA); British Association of Specialist Knee Surgeons (BASK) and American Academy of Orthopaedic Surgeons (AAOS). The annual conferences of the BOA and the AAOS have attendances of 1,600 and 32,000 surgeons respectively. The results of the research are likely to attract significant attention at meetings; particularly as the presentation of RCT evidence in this field is rare.

Wider clinical community. The aim is to publish the protocol in the first year and publish the results in at least one major peer-reviewed publication by the end of the study. If a full trial is feasible the results are likely to attract significant attention. It is hoped that this research will assist NICE in updating the clinical pathway for VTE which includes guidance for elective hip and knee replacement surgery and the specific NICE clinical guideline “CG92 VTE: reducing the risk”.

Intention to publish date

31/12/2021

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/02/2016: Study status verified with principal investigator.