Condition category
Injury, Occupational Diseases, Poisoning
Date applied
11/05/2020
Date assigned
19/05/2020
Last edited
02/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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 cost to the National Health Service. Another way to hold the bone is to use 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 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 its 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 September 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

Trial website

http://www.york.ac.uk/healthsciences/research/trials/research/trials/sofft/

Contact information

Type

Scientific

Primary contact

Mrs Elizabeth Cook

ORCID ID

http://orcid.org/0000-0001-6902-0235

Contact details

York Trials Unit
Department of Health Sciences
Faculty of Science
Ground Floor
ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904 321522
liz.cook@york.ac.uk

Type

Scientific

Additional contact

Prof Adam Watts

ORCID ID

http://orcid.org/0000-0003-0795-6462

Contact details

Wrightington
Wigan & Leigh NHS Foundation Trust
Hall Lane
Appley Bridge
Wigan
WN6 9EP
United Kingdom
-
Adam.C.Watts@wwl.nhs.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 45217, IRAS 276873

Study information

Scientific title

Suture fixation versus tension band wiring for simple olecranon fracture fixation: a multi-centre randomised controlled trial (Simple Olecranon Fracture Fixation Trial – SOFFT)

Acronym

SOFFT

Study hypothesis

The functional outcome, measured by the DASH score at 4 months, for the tension suture repair technique will not be inferior to traditional tension band wiring for the internal surgical fixation of Mayo Grade IIA fractures of the olecranon in adult patients over the age of 16 years.

Ethics approval

Approval pending, North West - Greater Manchester Central Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 1048191; gmcentral.rec@hra.nhs.uk), REC ref: 20/NW/0234

Study design

Randomised; Both; Design type: Treatment, Surgery, Health Economic

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

The participant information sheet has been uploaded

Condition

Olecranon fracture

Intervention

This is a multi-centre, randomised controlled non-inferiority trial, with an internal pilot phase to check the assumptions about recruitment and provide guidance on optimising the trial processes.

This study will be carried out in up to 35 NHS major trauma centres and Trauma Units within the UK treating olecranon fractures and with facilities to support research activity.

A total of 280 (140 in the intervention group and 140 in the control group) male and female patients will be recruited for the study.

Prior to study involvement: Patients will be given a participant information sheet to read and be given sufficient time to consider this information.

Eligible and consenting patients will be randomly allocated to either tension suture repair or standard tension band wiring. Participants will not be informed of their treatment allocation.

Intervention: fixation using tension suture repair
Control: fixation using tension band wiring

Postoperatively, patients will receive all other medical care including physiotherapy as per standard of care.

All patients randomised into the two groups will also receive standardised, written physiotherapy advice detailing suggested exercises they are to perform.

The researchers will assess outcomes at the start of the study, then at 4, 12, and 18 months and some at 24 months when participants will complete questionnaires that measure elbow function and pain. Participants will attend a clinic visit that will include x-rays to check healing at 4 months. The associated costs of both treatments to the NHS will also be evaluated.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

Physical function of the upper limb measured using the Disabilities of the Arm Shoulder and Hand (DASH) score at 4 months

Secondary outcome measures

Collected at 4, 12 and 18 months post-randomisation for the whole population, and at 24 months post-randomisation only for those who reach that follow-up point within the trial recruitment and follow-up window of up to month 48 of the study (unless stated otherwise):
1. Physical function of the upper limb measured using the Disabilities of the Arm Shoulder and Hand (DASH) score at 12, 18, and 24 months
2. Pain measured using a Numeric Rating Scale
3. Patient satisfaction measured using a Net Promotor Score
4. Health-related quality of life measured using EuroQol 5 Dimensions (5L) Score (EQ5D-5L). EQ-5D-5L data will be collected twice at baseline: i.e. once to assess patient health-related quality of life on the day (after the injury) and once with regard to the week before injury.
5. Radiological union measured using x-ray imaging at 4 months
6. Complications collected by patient-reported questionnaires and review of hospital records
7. Elbow range of movement (flexion, extension, pronation and supination) assessed by a suitably trained independent observer using a hand-held goniometer following trial-specific instructions at 4 months
8. Re-operations related to the injury or to remove metalwork; reason for reoperation will be recorded
9. Resource use and work impact: patient-reported questionnaires and hospital forms will be designed to collect information on hospital stay (initial and subsequent inpatient episodes, outpatient hospital visits and A&E admissions); primary care consultations (e.g. GP, nurse and physiotherapy); work impact of both interventions; and return to work and return to normal activities.

Overall trial start date

01/11/2019

Overall trial end date

30/09/2024

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Patients aged > = 16 years
2. Mayo Grade IIA acute olecranon fracture within 3 weeks of injury
3. Closed or Gustillo and Anderson grade 1 open injury
4. The surgeon believes the patient will benefit from surgical intervention
5. Ability to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 280; UK Sample Size: 280

Participant exclusion criteria

1. Surgery contra-indicated
2. Gustillo and Anderson grade 2 or 3 open injury
3. Associated upper limb injuries or prior upper limb pathology adversely affecting function
4. Evidence of fracture comminution (Mayo Grade IIB) or instability around the elbow and/or forearm (Mayo Grade III)
5. Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires
6. Previous entry into SOFFT
7. Concurrent olecranon fracture in the opposite limb

Recruitment start date

01/10/2020

Recruitment end date

30/09/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Wrightington, Wigan and Leigh NHS Foundation Trust (Lead Site)
Wrightington Hospital Hall Lane Appley Bridge
Wigan
WN6 9EP
United Kingdom

Trial participating centre

University Hospitals Of Leicester NHS Trust
Leicester General Hospital Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Trial participating centre

NHS Lothian
Edinburgh Royal Infirmary Royal Infirmary of Edinburgh 51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

North West Anglia NHS Foundation Trust
Peterborough City Hospital Bretton Gate
Peterborough
PE3 9GZ
United Kingdom

Trial participating centre

Brighton and Sussex University Hospitals NHS Trust
Royal Sussex County Hospital Eastern Road
Brighton
BN2 5BE
United Kingdom

Sponsor information

Organisation

Wrightington, Wigan and Leigh NHS Foundation Trust

Sponsor details

c/o Mrs Joanne Farnworth
Wrightington
Wigan & Leigh NHS Foundation Trust
Hall Lane
Appley Bridge
Wigan
WN3 9NP
United Kingdom
+44 (0)1257 488229
Joanne.Farnworth@wwl.nhs.uk

Sponsor type

Hospital/treatment centre

Website

http://www.wwl.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: 127739

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Additional documentation will be added to the NIHR website when available. Exact plans unknown but planned publication as an NIHR HTA Monograph and in international, open-access peer-reviewed journals. Results will be disseminated through the local networks, and at national and international meetings in surgical care. The study findings will be presented at national and international meetings of organisations such as the British Orthopaedic Association Annual Congress, UK Orthopaedic Trauma Society, the British Shoulder and Elbow Society, North American Orthopaedic Trauma Association, European Federation of National Associations of Orthopaedics and Traumatology (EFORT), European Shoulder and Elbow Society (SECEC) and American Academy of Orthopaedic Surgeons. The findings will also be disseminated to participants in the form of a plain English summary which will be agreed by the Patient and Public Involvement (PPI) group.

IPD sharing statement
The datasets generated during and/or analysed during the current study (fully anonymised) will be available upon request after the publication of the study results from Prof. David Torgerson (David.Torgerson@york.ac.uk).

Intention to publish date

30/09/2025

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

02/06/2020: A scientific contact was added. 11/05/2020: Trial's existence confirmed by the NIHR.