Ankle fracture fixation with or without a tourniquet

ISRCTN	ISRCTN91783787
DOI	https://doi.org/10.1186/ISRCTN91783787
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Integrated Research Application System (IRAS)	331292
Protocol serial number	SOC.05/24-25, CPMS 67205
Sponsor	University of Warwick
Funder	National Institute for Health and Care Research

Submission date: 02/04/2025
Registration date: 14/05/2025
Last edited: 03/07/2025

Recruitment status: Recruiting
Overall study status: Ongoing
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Ankle fracture fixation surgery is common. Some surgeons perform this operation with the use of a tourniquet. This is a cuff device placed around the patient’s thigh during surgery. Benefits of tourniquet use may include less bleeding, better visibility, and shorter procedure time. However, tourniquets may cause pain and increase the risks of complications, e.g. infection. A definitive randomised controlled trial (RCT) is needed to compare outcomes on this topic and address clinical uncertainties. In preparation, a two-centre feasibility RCT and qualitative interviews will be carried out to improve the quality of the future trial and determine key study parameters. These include recruitment rate, reasons for non-participation, equipoise, effectiveness and views on blinding processes, protocol non-adherence, data incompleteness, and required sample size. This study aims to determine whether a full RCT evaluating outcomes of ankle fracture fixation surgery performed with or without a tourniquet is feasible.

Who can participate?
Feasibility RCT: patients over the age of 18 years undergoing primary fracture fixation surgery from either University Hospital Coventry & Warwickshire (UHCW) or Royal London Hospital (RLH).
Qualitative interviews: patients over the age of 18 years undergoing primary fracture fixation surgery and Consultant Trauma & Orthopaedic Surgeons from either UHCW or RLH.

What does the study involve?
Consented RCT patients will be randomly allocated to the intervention (tourniquet to be used) or control (tourniquet not to be used). After the surgery, they will get the same care as if they hadn’t joined the study, however they will be asked to fill out short questionnaires at 1 day, 3 weeks, and 3 months after the operation and will be followed up 3 months past their ankle fracture fixation surgery. Consented interview participants will take part in a 30–60-minute interview.

What are the possible benefits and risks of participating?.
There will not be any direct benefit from taking part but the participants will help to improve the quality of any future trial.
The RCT study risks are similar whether the surgery is carried out with or without a tourniquet and are the same if patients choose not to participate in this research (risks of pain, bleeding, blood clots, damage to nerves and blood vessels, and risks related to the anaesthetic). There may be different risks depending on whether or not the tourniquet is used. Some surgeons think that using a tourniquet might cause problems such as more pain after the operation or a higher chance of wound problems, or having a blood clot. On the other hand, there may be more bleeding during the operation if a tourniquet is not used, which may make the operation more challenging for the surgeon to do.
The interview study has no anticipated risks.

Where is the study run from?
The study is run from the University of Warwick in collaboration with University Hospitals Coventry and Warwickshire’s Trial Management Unit (UK)

When is the study starting and how long is it expected to run for?
March 2025 to February 2026

Who is funding the study?
The National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
1. Muhamed Farhan-Alanie (Research Fellow), muhamed.alanie@doctors.org.uk
2. For trial management-specific queries: Cristiana Huhulea (Trial Coordinator), cristiana.huhulea@uhcw.nhs.uk

Contact information

Miss Cristiana Huhulea
Public

Research and Development
University Hospitals Coventry and Warwickshire
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Phone	+44 (0)24 7696 7476
Email	cristiana.huhulea@uhcw.nhs.uk

Mr Muhamed Farhan-Alanie
Principal investigator

Warwick Clinical Trials Unit
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Phone	+44 (0)7503237036
Email	muhamed.alanie@doctors.org.uk

Prof Julie Bruce
Scientific

Warwick Clinical Trials Unit
University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Phone	Not available
Email	julie.bruce@warwick.ac.uk

Study information

Primary study design	Interventional
Study design	Feasibility randomized controlled trial and integrated qualitative interview study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Tourniquet use in ankle fracture fixation surgery: a feasibility randomised controlled trial
Study acronym	AFFixT
Study objectives	To determine the feasibility of conducting a randomised controlled trial examining the benefits and risks of using a tourniquet in ankle fracture fixation surgery.
Ethics approval(s)	Approved 08/05/2025, East of England - Essex Research Ethics Committee (2 Redman Place, London, EC20 1 JQ, United Kingdom; +44 (0)207 104 8106; Essex.REC@hra.nhs.uk), ref: 25/EE/0051
Health condition(s) or problem(s) studied	Primary fracture fixation surgery
Intervention	This is a multi-centre feasibility RCT recruiting ankle fracture patients from University Hospitals Coventry and Warwickshire and Royal London Hospital with an embedded qualitative element (interviews) for both patients and staff. Consented RCT patients will be randomised 1:1 by block randomisation to the intervention (tourniquet to be used) or control (tourniquet not to be used) and will be followed-up 3 months past their ankle fracture fixation surgery. Patients and surgeons will be blinded to the randomization allocation. The embedded qualitative interviews will be conducted with both patients and consultant trauma and orthopaedic surgeons who participated or declined to participate in the feasibility randomised controlled trial.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Tourniquet
Primary outcome measure(s)	1. Recruitment rates measured throughout the recruitment period using a study site tracker 2. Retention rates will be assessed at the end of the study by comparing the number of participants recruited and those who have completed the study 3. Data completeness will be assessed periodically using reports from the database 4. Blinding feasibility will be assessed based on reports of unblinding (up to 3 months post patient ankle fracture fixation) and explored during the surgeon qualitative interviews 5. Intervention adherence will be measured throughout the study recruitment and follow-up period, based on reported protocol deviations/violations
Key secondary outcome measure(s)	1. Post-operative pain measured at baseline, 24 hours, 3 weeks and 3 months post-operatively using the painDETECT questionnaire and 11-point pain Numerical Rating Scale 2. Surgical field of view measured on the day of the procedure using a 5-point Likert scale 3. Blood loss and blood transfusions measured on the day of the procedure and up to 2 weeks post-procedure by measuring the weight of the surgical swabs, volume of blood collected and number of intraoperative and post-operative blood transfusions 4. Length of procedure measured on the day of the procedure 5. Skin assessment will be assessed pre-operatively and on the day of the procedure and collected from medical notes 6. Awareness of tourniquet use will be measured post-operatively using a self-completed questionnaire 7. Health-related quality of life will be measured at baseline, 3 weeks and 3 months post-operatively using a modified EQ5D5L questionnaire 8. Functional recovery after the ankle injury will be assessed using the Olerud-Molander Ankle Score at baseline, 3 weeks and 3 months post-operatively 9. Post-operative complications measured 3 months post-procedure will be captured using a patient self-reported questionnaire 10. Intra-operative complications will be captured on the day of the procedure through a surgeon-completed questionnaire
Completion date	01/02/2026

Eligibility

Participant type(s)	Patient, Health professional
Age group	Adult
Lower age limit	18 Years
Upper age limit	100 Years
Sex	All
Target sample size at registration	74
Key inclusion criteria	Feasibility RCT: 1. Aged 18 years and over 2. Patients undergoing primary fracture fixation surgery for a closed ankle fracture within 2 weeks of date of injury under general and/or regional anaesthetic 3. Capacity to give informed consent Embedded Qualitative Interview Study: 1. Aged 18 years and over 2.1. Consultant Trauma & Orthopaedic Surgeons who participated or declined to participate in the feasibility randomised controlled trial OR 2.2. Patients who participated or declined to participate in the feasibility randomised controlled trial 3. Ability to provide informed consent
Key exclusion criteria	Feasibility RCT: 1. Patients with a pilon fracture 2. Unable to understand and speak English (or does not have relative willing to translate) 3. Patients with a chronic musculoskeletal or neurological condition (excluding diabetes mellitus) affecting the operative limb, or a history of prior surgery on the affected limb Embedded Qualitative Interview Study: 1. Unable to understand and speak English (or does not have relative willing to translate)
Date of first enrolment	19/06/2025
Date of final enrolment	01/12/2025

Locations

Countries of recruitment

United Kingdom
England

Study participating centres

University Hospitals Coventry and Warwickshire NHS Trust

Walsgrave General Hospital
Clifford Bridge Road
Coventry
CV2 2DX
United Kingdom

Barts Health NHS Trust

The Royal London Hospital
80 Newark Street
London
E1 2ES
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The datasets generated and/or analysed during the current study will be available upon request from the chief investigator, Prof. Julie Bruce (Julie.Bruce@warwick.ac.uk) or clinical research fellow, Mr. Muhamed Farhan-Alanie (muhamed.farhan-alanie@nhs.net) by written application that will need to also be approved by the sponsor. Only anonymised data will be shared with external researchers. Consent from participants is being obtained to allow the researchers to share their data anonymously.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

03/07/2025: The following changes were made to the trial record:
1. The date of first enrolment was changed from 01/06/2025 to 19/06/2025.
2. The participant level data sharing statement was added.
08/04/2025: Study's existence confirmed by the NIHR.