Surgery or using a sling to support the arm for treating adults with a broken collarbone near the shoulder joint (displaced fracture of the distal clavicle)
| ISRCTN | ISRCTN11981704 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11981704 |
| IRAS number | 321203 |
| Secondary identifying numbers | IRAS 321203, CPMS 56625 |
- Submission date
- 24/07/2023
- Registration date
- 31/07/2023
- Last edited
- 24/03/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Fractures of the clavicle, which primarily occur in young males, constitute 2.6–5% of all fractures in adults. Distal clavicle fractures account for 20-25% of all clavicle fractures. These are treated with an operation, involving fracture fixation, or with sling immobilisation. Patients treated with surgery may have a reduced risk of the fracture not healing (non-union) and may have quicker recovery. However, they are at risk of complication; (estimated at 48%) including infection, plate breakage and refracture after metal removal. Upper limb support with a sling, typically between 2 and 4 weeks, restricts activity whilst providing comfort during the early painful stages of healing. The risk of non-union with a sling can be up to 35-40% but appears to cause minimal functional deficits in most individuals. If a non-union occurs, and surgical intervention is indicated, it can prolong the treatment period and increase costs. Using HES data for 2019 and HRG codes the cost to the NHS of surgical fixation in this fracture population is approximately £6 million per annum. At a time when the NHS is under more pressure than ever with the impact of COVID-19, it is important to answer the question of whether a potentially cheaper, safe and non-surgical option can replace more costly and invasive surgery.
The study aims to determine whether self-reported functional outcome, measured by the Disability of Arm, Shoulder and Hand (DASH) at one year, following sling immobilisation is not inferior to surgical fixation in adults with a displaced fracture of the distal clavicle and whether this is a cost-effective treatment option.
Who can participate?
The target population is adults with a radiological diagnosis of a displaced fracture of the distal clavicle that does not involve the acromioclavicular joint. The setting will be Major Trauma Centres and Trauma Units within the United Kingdom. Patients will be identified either in the Emergency Department or Fracture Clinic and will attend for routine out-patient appointment at 6 weeks, 3 and 12 months. Data will also be collected at 6 months.
What does the study involve?
If a participant decides to take part in the study they will be asked for written consent (either on paper or electronically) and to answer a list of questions. Taking part in this study means the patient or surgeon can’t choose the treatment. Instead, a scientific process called randomisation determines which treatment the participant receives. This will be a 50:50 chance of wearing a sling or having surgery. To find out which treatment for broken collarbones works best, we will regularly contact all 214 patients who take part in our study. This will include attending hospital when feasible for routine appointments at 6 weeks, 3 and 12 months from taking part in the study. This will include an assessment of bone healing and whether any further treatment is necessary. Participants will also be asked to complete questionnaires electronically or on paper at 6 weeks, 3, 6 and 12 months after their decision to take part in the study.
What are the possible benefits and risks of participating?
Treating this type of collarbone injury can only be improved with the help of patients. It is hoped taking part will help improve medical care for future patients and be a rewarding experience and the patient may also have more support because of the wider team involved in this research. All surgery involves risks, such as from general anaesthesia, bleeding, deep vein thrombosis, damage to nerves and blood vessels in the surgical area and infection. Patients treated with a sling may experience swelling, bruising, discomfort or stiffness. Patients may also need surgery after initial sling care if the bone does not heal. However, there is no increased risk to a patient by taking part in the study as the NHS has treated patients in these ways with this type of collarbone injury for many years.
Where is the study run from?
University Hospitals of Leicester NHS Trust (UK)
When is the study starting and how long is it expected to run for?
November 2022 to December 2026
Who is funding the study?
The study is funded by the National Institute for Health Research (Health Technology Assessment) programme (UK)
Who is the main contact?
ytu-didact@york.ac.uk
Stephen Brealey, stephen.brealey@york.ac.uk
Sam Swan, sam.swan@york.ac.uk
Contact information
Principal Investigator
University Hospitals of Leicester NHS trust
Balmoral Building
Infirmary Square
Leicester
LE1 5WW
United Kingdom
 ORCID ID |
0000-0002-8686-2802 |
|---|---|
| Phone | +44 (0)7739714549 |
| Harvinder.P.Singh@uhl-tr.nhs.uk |
Scientific
York Trials Unit
Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom
| ORCID ID |
0000-0001-9749-7014 |
|---|---|
| Phone | +44 (0)1904 321357 |
| stephen.brealey@york.ac.uk |
Public
York Trials Unit
Department of Health Sciences
University of York
York
YO10 5DD
United Kingdom
| ORCID ID |
0009-0000-2255-1012 |
|---|---|
| Phone | +44 (0)1904 328511 |
| sam.swan@york.ac.uk |
Study information
| Study design | Two-arm pragmatic multi-centre randomized non-inferiority trial with parallel groups with a 12 month internal and a full health economic evaluation |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43994_PIS_V1.1_23Jun23.pdf |
| Scientific title | Surgery compared with sling immobilisation in the management of adults with a displaced fracture of the distal clavicle (DIDACT): a multi-centre, pragmatic, parallel group, non-inferiority, randomised controlled trial |
| Study acronym | DIDACT |
| Study hypothesis | The primary objective of DIDACT is to determine whether self-reported functional outcome, measured by the Disability of Arm, Shoulder and Hand (DASH) at 12 months, following sling immobilisation is not inferior to surgical fixation in adults with a displaced fracture of the distal clavicle. Secondary objectives include confirming the feasibility of the study in a 12 month internal pilot, determining the effectiveness of the two treatment options in adults with a displaced fracture of the distal clavicle, and to determine the cost-effectiveness of the two treatments. |
| Ethics approval(s) |
Approved 11/07/2023, East of England - Essex Research Ethics Committee (2nd Floor, 2 Redman Place, Stratford, London, E20 1JQ, United Kingdom; +44 207 104 8000; Essex.REC@hra.nhs.uk), ref: 23/EE/0123 |
| Condition | A radiological diagnosis of a displaced fracture of the distal clavicle that does not involve the acromioclavicular joint. |
| Intervention | DIDACT is a two-arm, pragmatic, multi-centre, randomised, non-inferiority trial with parallel groups, allocated on a 1:1 ratio using random permuted blocks of random block size and stratified by age (<65 or ≥65 years). There will be a 12 month internal pilot to assess the assumptions about site set up and recruitment. The trial will include a full health economic evaluation. As with many surgical trials, it will not be feasible to blind patients, surgeons, or outcome assessors to the treatment allocation. Intervention: Surgical Fixation: Locking plate fixation, with or without coracoclavicular (CC) sling, or CC reconstruction alone. Comparator: Sling Immobilization: upper limb support with a sling, typically for 2 to 4 weeks, followed by surgical fixation if symptomatic non-union of the fracture typically at the 3 month follow-up |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Patient-reported functional outcome measured by the Disability of Arm, Shoulder and Hand (DASH) at 12 months. |
| Secondary outcome measures | 1. Patient-reported functional outcome measured by DASH score at 6 weeks, 3 and 6 months, and over 12 months 2. Shoulder pain measured using an 11-item unidimensional numerical rating scale of pain intensity in adults with 0 representing ‘no pain’ and 10 representing ‘worst imaginable pain’ in the past 24 hours at 6 weeks, 3, 6, and 12 months 3. Quality of life measured using EQ5D-5L at 6 weeks, 3, 6, and 12 months 4. Complications (e.g. infections, re-operations) measured using Centres for Disease Control (CDC) and Prevention definition for superficial and deep infection and record on a bespoke CRF rehospitalisation (e.g. repeat surgery to remove metalwork), nerve and skin problems and collected at 6 weeks, 3 and 12 months 5. Fracture healing (e.g. union, nonunion, malunion) measured using routine radiographs (typically anteroposterior and axial views) by the participating surgeons in clinic at 3 and 12 months 6. Patient preferences, satisfaction with the appearance of their shoulder/sensitivity or pain to touch, measured using a 5-item unidimensional Likert scale that ranges from ‘Very satisfied’ to ‘Very dissatisfied’ at 12 months and range of movement measured by participants using a diagram based questionnaire at 12 months |
| Overall study start date | 01/11/2022 |
| Overall study end date | 31/12/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 214 |
| Participant inclusion criteria | 1. Aged 18 years or older. 2. Displaced extra-articular (outside the joint) fracture of the distal clavicle based on routine radiographic assessment, with or without polytrauma. 3. Able and willing to give consent. |
| Participant exclusion criteria | 1. The index injury is >21 days. 2. An upper extremity fracture both more proximal or distal to the same affected shoulder e.g. floating shoulder. 3. The fracture is open. 4. The fracture is complicated by local tumour deposits. 5. The fracture is associated with a nerve palsy or vessel injury. 6. Comorbidities precluding surgery or anaesthesia. 7. Unable or unwilling to give consent. 8. Must not be related to any member of the local study team. |
| Recruitment start date | 01/09/2023 |
| Recruitment end date | 30/06/2025 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Infirmary Square
Leicester
LE1 5WW
United Kingdom
80 Newark Street
London
E1 2ES
United Kingdom
Mindelsohn Way
Edgbaston
Birmingham
B15 2GW
United Kingdom
Sibsey Road
Boston, Lincolnshire
PE21 9QS
United Kingdom
Hardwick Lane
Bury St. Edmunds
IP33 2QZ
United Kingdom
Cambridge
CB2 0QQ
United Kingdom
Barrack Road
Exeter
EX2 5DW
United Kingdom
Gloucester
GL1 3NN
United Kingdom
Acre Street
Lindley
Huddersfield
HD3 3EA
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Thomas Drive
Liverpool
L14 3LB
United Kingdom
Windmill Road
Gillingham
ME7 5NY
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Cliftonville
Northampton
NN1 5BD
United Kingdom
Southmead Road
Westbury-on-trym
Bristol
BS10 5NB
United Kingdom
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Odstock Road
Salisbury
SP2 8BJ
United Kingdom
Stoke-on-trent
ST4 6QG
United Kingdom
Wrightington
Wigan
WN6 9EP
United Kingdom
Lydeard House
Musgrove Park Hospital
Taunton
TA1 5DA
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Victoria Road
Macclesfield
SK10 3BL
United Kingdom
Anlaby Road
Hull
HU3 2JZ
United Kingdom
Dundee
DD1 9SY
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road Glasgow
Glasgow
G12 0XH
United Kingdom
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
Gorleston
Great Yarmouth
NR31 6LA
United Kingdom
Bretton Gate
Bretton
Peterborough
PE3 9GZ
United Kingdom
Holdforth Road
Hartlepool
TS24 9AH
United Kingdom
Aldermaston Road
Basingstoke
RG24 9NA
United Kingdom
Sponsor information
Hospital/treatment centre
Leicester Royal Infirmary
Infirmary Square
Leicester
LE1 5WW
England
United Kingdom
| Phone | +44 (0)116 258 4109 |
|---|---|
| uhlsponsor@uhl-tr.nhs.uk | |
| Website | https://www.leicestershospitals.nhs.uk/ |
"ROR" |
https://ror.org/02fha3693 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | A number of dissemination channels will be used to inform clinicians, patients and the public about the project and the results of the study, including: 1. The study protocol will be published in a peer-reviewed, open access journal, before the end of recruitment. 2. A HTA monograph will be produced. 3. On completion of the study, the findings of the trial will be presented at national and international meetings of organisations that will target orthopaedic surgeons such as the British Orthopaedic Association (BOA) Annual Congress and the British Shoulder and Elbow Society (BESS). 4. The study findings and patient-focused outputs will be cascaded to trainee surgeon networks (e.g. BOTA, CORNET) and we will seek to upload these outputs on their websites. The study findings will also be cascaded to Industry who produce the implants and also to Getting It Right First Time (GIRFT) which is a national programme designed to improve medical care within NHS by reducing unwarranted variations. 5. The study report will be published in peer reviewed high impact general medical and orthopaedic journals. 6. A plain English summary leaflet of the study findings, will be produced and made available to participants, members of our user group and relevant patient-focused websites. In conjunction with the PAG we will develop an infographic and an animation to disseminate the findings. 7. The executive summary and copy of the trial report will be sent to NICE and other relevant bodies. 8. The findings of the SWAT will be disseminated in a relevant journal read by trialists and disseminated at relevant conferences. 9. These outputs will also be uploaded to various webpages (e.g. Sponsor, YTU, BESS, Wikipedia, ISRCTN registry). The various outputs that we produce will be freely available to the NHS and public and is likely to only require IP protection with the use of a copyright statement from the Sponsor. |
| IPD sharing plan | All data requests should be submitted to the Chief Investigator as will be specified in our publication plan. Access to anonymised data may be granted following review with the Trial Management Group and agreement of the Chief Investigator and Sponsor. Related documents including the statistical analyses plan will be available on request. Harvinder.P.Singh@uhl-tr.nhs.uk |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.1 | 23/06/2023 | 28/07/2023 | No | Yes |
| Protocol file | version 1.0 | 12/04/2023 | 28/07/2023 | No | No |
| Protocol file | version 3.0 | 11/11/2024 | 28/02/2025 | No | No |
Additional files
Editorial Notes
24/03/2025: Contact details updated.
28/02/2025: Participant information sheet added. NHS Greater Glasgow and Clyde, University Hospitals of Derby and Burton NHS Foundation Trust, James Paget University Hospitals NHS Foundation Trust, North West Anglia NHS Foundation Trust, North Tees & Hartlepool NHS Foundation Trust and North Tees & Hartlepool NHS Foundation Trust were added to the study participating centres.
08/10/2024: The following changes have been made:
1. Blackpool Teaching Hospitals NHS Foundation Trust, Royal Gwent Hospital, Lancashire Teaching Hospitals NHS Foundation Trust and Swansea Bay University Health Board were removed from the study participating centres.
2. Somerset NHS Foundation Trust, Nottingham University Hospitals NHS Trust - Queen's Medical Centre Campus, East Cheshire NHS Trust, Hull University Teaching Hospitals NHS Trust and Tayside were added to the study participating centres.
3. Scotland was added to the Countries of recruitment.
28/07/2023: Study's existence confirmed by the HRA.
