A comparison of two methods of surgical fixation for the treatment of simple olecranon fractures in adults

Plain English Summary

Background and study aims
Fractures (a break in the bone) of the olecranon (bony point of the elbow) are common and usually happen after a fall onto the elbow. The risk of having this fracture increases as we get older. If a patient is well enough they usually have surgery to fix the fracture as a day case. Commonly the bone is held using tension band wiring technique, a metal wire bent around the bone and two smooth pins. This is effective in holding the position for the fracture to heal. However, the wires can cause pain because they lie just under the skin. One in three patients will have a second operation to remove the wires, exposing them to further surgical risks and resulting in increased costs to the National Health Service. Another way to hold the bone is to use a strong material cord (tension suture fixation). Some small studies looking at this technique have shown that this can reliably hold the bones in a good position while they heal and that the patient does not experience any discomfort from the prominence of the suture material. One small study found the need for further surgery was reduced to less than one in twenty. This is better for the patients and could save the NHS about 4 million pounds a year but a larger study is needed to confirm this finding. This study aims to compare two methods of surgical treatment for adult patients with olecranon fractures to find out which has a better patient outcome in terms of return to function.

Who can participate?
Patients aged 16 years or older who attend a participating hospital with an olecranon fracture

What does the study involve?
Participants are randomly allocated to either receive surgery using tension suture repair or tension band wiring to fix the fracture. Participants are assessed at the start of the study, then at 4, 12 and 18 months, and some participants at 2 years. Participants complete a few questionnaires, an assessment of elbow range of motion (at 4 months), and have x-rays to check healing at 4 months. The cost of both treatments is calculated relative to their benefits to find out which is better value for money for the NHS.

What are the possible benefits and risks of participating?
Within the trial, participants allocated to receive tension suture repair may experience benefit as they may be less likely to require a second surgery to remove the fixation material, thereby reducing the risks associated with surgery and the inconvenience for the patient, though the purpose of the study is to provide evidence regarding this.
This study only includes treatments that are already used in the NHS but as with many medical procedures, there are some potential risks, mainly in relation to the surgery and anaesthesia. Most commonly, patients may experience pain around the arm. This usually improves after 48 hours or so as the body heals. Some patients feel nauseous or light-headed after surgery due to the anaesthetic, which usually passes over 24 hours. It is rare, but some people can have a bad reaction to anaesthesia. Severe allergic reactions to anaesthesia are very rare, less than 1 in 1000. Specific common risks to the tension wiring banding technique include that further surgical procedures may need to be carried out, for example, to remove the metalwork as it may be uncomfortable, move or fail. Based on clinical experience it is estimated that one in five may require removal. No specific common risks with tension suture repair technique have been identified. This is a newer technique and risks may include a need to re-operate if the fixation fails.

Where is the study run from?
Wrightington, Wigan and Leigh NHS Foundation Trust (lead site) (UK)

When is the study starting and how long is it expected to run for?
November 2019 to June 2024

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

Who is the main contact?
Liz Cook
liz.cook@york.ac.uk

Study website

Contact information

Mrs Elizabeth Cook
Scientific

York Trials Unit
Department of Health Sciences
Faculty of Science
Ground Floor, ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom

ORCID ID	0000-0001-6902-0235
Phone	+44 (0)1904 321522
Email	liz.cook@york.ac.uk

Prof Adam Watts
Scientific

Wrightington, Wigan & Leigh NHS Foundation Trust
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom

ORCID ID	0000-0003-0795-6462
Email	Adam.C.Watts@wwl.nhs.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Wrightington, Wigan and Leigh NHS Foundation Trust
Hospital/treatment centre

c/o Mrs Joanne Farnworth
Wrightington, Wigan & Leigh NHS Foundation Trust
Hall Lane, Appley Bridge
Wigan
WN3 9NP
England
United Kingdom

Phone	+44 (0)1257 488229
Email	Joanne.Farnworth@wwl.nhs.uk
Website	http://www.wwl.nhs.uk/
"ROR"	https://ror.org/028mrxf52

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN87904264 SOFFT Statistical Analysis Plan_V 1_21Feb24.pdf

ISRCTN87904264_HEAP_V1_14May24.pdf

Health economics analysis plan

Editorial Notes

19/06/2024: Health economics analysis plan added.
17/06/2024: The statistical analysis plan was uploaded as an additional file.
20/02/2024: The study participating centres Cardiff and Vale University Health Board, Bart’s Health NHS Trust, Greater Glasgow Health Board, East and North Hertfordshire NHS Trust, Royal Devon and Exeter NHS Foundation Trust, The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust, Tayside Health Board, Betsi Cadwaladr University Local Health Board, Oxford University Hospitals NHS Foundation Trust, Kings College Hospital NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, University College London Hospitals NHS Foundation Trust, Milton Keynes University Hospital NHS Foundation Trust, Liverpool University Hospitals NHS Foundation Trust, St George’s University Hospitals NHS Foundation Trust, Royal United Hospitals Bath NHS Foundation Trust, Wirral University Teaching Hospital NHS Foundation Trust, Hampshire Hospitals NHS Foundation Trust,
Frimley Health NHS Foundation Trust, Maidstone & Tunbridge Wells NHS Trust, Queen Elizabeth Hospital King’s Lynn NHS Foundation Trust, Calderdale and Huddersfield NHS Foundation Trust, North Cumbria Integrated Care NHS Foundation Trust, Bradford Teaching Hospitals NHS Foundation Trust, North Bristol NHS Trust, James Paget University Hospitals NHS Foundation Trust, Southport and Ormskirk Hospital NHS Trust, Royal Cornwall Hospitals NHS Trust, Kingston Hospital NHS Foundation Trust, Sheffield Teaching Hospitals NHS Foundation Trust, Whittington Health NHS Trust, Somerset NHS Foundation Trust, Oxford University Hospitals NHS Foundation Trust, Hampshire Hospitals NHS Foundation Trust were added.
06/02/2024: The overall study end date was changed from 30/09/2024 to 30/06/2024.
24/01/2023: Publication reference added.
06/01/2023: Total final enrolment added.
14/09/2022: The recruitment end date was changed from 30/09/2022 to 31/12/2022.
22/10/2020: The recruitment start date was changed from 01/10/2020 to 13/10/2020.
16/10/2020: The ethics approval was added.
02/06/2020: A scientific contact was added.
11/05/2020: Trial's existence confirmed by the NIHR.