In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention?
| ISRCTN | ISRCTN67007305 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN67007305 |
| Secondary identifying numbers | CPMS 42891 |
- Submission date
- 23/09/2019
- Registration date
- 01/10/2019
- Last edited
- 06/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Injury, Occupational Diseases, Poisoning
Plain English Summary
Background and study aims
Ankle fracture is one of the most common UK musculoskeletal injuries. Routinely, unstable fractures are treated with surgery to maintain the joint alignment whilst the fracture heals. However, for patients who experience complications after surgery, their loss of ankle function and quality of life is considerable. An alternative, non-surgical treatment is to apply a close contact cast (CCC); a plaster cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint. The key benefit of CCC is a reduced risk of the complications of surgery. The main potential risk of CCC is a loss of joint alignment with a consequent reduction in ankle function. CCC is a current evidence-based treatment in the UK for patients over 60.
This study aims to determine whether ankle function four months after treatment in younger adult patients with unstable ankle fractures treated with CCC is not worse than those treated with surgery, which is the current standard-of-care.
Who can participate?
Adult patients aged up to 60 with unstable ankle fractures
What does the study involve?
Participants will be randomised to receive either surgical or non-surgical treatment. All treatments will be delivered under the supervision of a consultant trauma and orthopaedic surgeon. Data regarding ankle function, quality-of-life, complications and costs will be collected at eight weeks, four and twelve months and then annually for five years following treatment.
What are the possible benefits and risks of participating?
The risks of the injury itself are the same for both groups of patients in the study, and are the same as for patients who are not taking part in the trial. Both treatments are used across the NHS currently and are not new or experimental. There is a small risk of complications if patients have the operation, such as infection and prominent metalwork, as with any surgery. We expect that some patients will need to return for a further operation. The specific risks of surgery would not apply with the close contact cast. The main potential risk of the cast treatment is that the bones move out of place, which may require further treatment, and that might be an operation. It is also possible that while patients are under anaesthetic, the surgeon decides he or she cannot hold your bones into the right position satisfactorily with the cast, and the patient would then receive an operation straight away.
Where is the study run from?
John Radcliffe Hospital, Oxford, UK
When is the study starting and how long is it expected to run for?
October 2019 to September 2028
Who is funding the study?
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)
Who is the main contact?
Mrs Anju Chalin
anju.chalin@ndorms.ox.ac.uk
Contact information
Scientific
Research Office 3
Kadoorie Centre, Level 3
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223123 |
|---|---|
| anju.chalin@ndorms.ox.ac.uk |
Scientific
Oxford Trauma Kadoorie Centre
Level 3 John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 223123 |
|---|---|
| fame@ndorms.ox.ac.uk |
Study information
| Study design | Randomized; Interventional; Design type: Treatment, Surgery |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention? The Fractured Ankle Management Evaluation (FAME) trial |
| Study acronym | FAME |
| Study hypothesis | Ankle fracture is one of the most common UK musculoskeletal injuries. Routinely, unstable fractures are treated with surgery to maintain the joint alignment whilst the fracture heals. However, for patients who experience complications after surgery, their loss of ankle function and quality-of-life is considerable. An alternative, non-surgical treatment is to apply a close contact cast (CCC); a plaster cast carefully shaped to the patient’s ankle to correct and maintain alignment of the joint. The key benefit of CCC is a reduced risk of the complications of surgery. The main potential risk of CCC is a loss of joint alignment with a consequent reduction in ankle function. CCC is a current evidence-based treatment in the UK for patients over 60. This study aims to determine whether ankle function four months after treatment in younger adult patients with unstable ankle fractures treated with CCC is not worse than those treated with surgery, which is the current standard-of-care. |
| Ethics approval(s) | Approved 03/09/2019, NHS HRA Leicester Central (Devonshire Place, 78 London Road, Leicester, LE2 0RA; +44 (0)207 1048107; NRESCommittee.EastMidlands-LeicesterCentral@nhs.net), ref: 19/EM/0264 |
| Condition | Unstable ankle fractures |
| Intervention | This trial is a pragmatic, multicentre, randomised non-inferiority clinical trial with parallel economic analysis, with direct participant follow-up to one year, and annual surveillance extending out to five years. Patients will be randomised to either surgery or close contact casting for treatment of their ankle injury; the randomisation will be on a 1:1 basis, stratified by centre and the presence or absence of posterior malleolus fracture, a specific indicator of instability. If noninferiority is demonstrated, superiority will also be investigated. In a 9-month pilot, we expect to open 9 sites and obtain a recruitment rate of at least 1 participant per centre per month. At the end of this pilot, the Data Safety and Management Committee will make recommendations to the Trial Steering Committee (TSC), as to whether the trial should continue. The TSC will evaluate this information and make a decision based on this and other information that they require for a decision. In the study as a whole, a total of 890 participants will be recruited in a minimum of 26 hospital orthopaedic or trauma departments within the UK. A member of the research team at the site will screen patients for eligibility, and when this is confirmed by a clinician, a GCP-trained member of the team will approach the patient to explain the study and gain informed consent. Participants will complete questionnaires at baseline, and site staff will complete a treatment questionnaire at the participant’s 6-week clinic visit. Participants will complete follow-up questionnaires at 8 weeks, 4 months and 12 months after treatment, thereafter they will be contacted annually for a further 4 years. We will also collect routine hospital data through a linkage with Hospital Episode Statistics (inpatient and emergency department datasets). Data will be collected via the clinical trial IT system REDCap, hosted by the University of Oxford, UK. Baseline data will be directly entered onto the database by the local research team. Participants will be contacted for follow-up using email and/or SMS text message prompts and invited to complete questionnaires through an online link, and telephone follow-up will be conducted for those who do not complete forms online. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Current primary outcome measure as of 16/12/2020: Ankle functional outcomes measured by the Olerud and Molander ankle score (OMAS) at 4 months. Previous primary outcome measure: Ankle functional outcomes measured by the Olerud and Molander ankle score (OMAS) at baseline and 4 months. |
| Secondary outcome measures | 1. OMAS at 8 weeks and 12 months 2. A-FORM (a specific ankle fracture questionnaire) at 8 weeks, 4 months and 12 months 3. Work Productivity and Activity Impairment (WPAI) at 8 weeks, 4 months and 12 months 4. Health-related quality of Life (EQ-5D-5L) at 8 weeks, 4 months and 12 months 5. Resource use, costs and comparative cost-effectiveness at 8 weeks, 4 months and 12 months and up to 5 years 6. OMAS, A-FORM, EQ-5D-5L and complications at all timepoints up to 5 years |
| Overall study start date | 01/05/2019 |
| Overall study end date | 05/09/2028 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 60 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 890; UK Sample Size: 890 |
| Total final enrolment | 891 |
| Participant inclusion criteria | 1. Patients who are able and willing to give informed consent for participation in the trial 2. Patients aged 18 to 60 years inclusive with an unstable ankle fracture 3. Patients who in the opinion of the treating surgeon may benefit from surgical treatment with internal fixation |
| Participant exclusion criteria | 1. The fracture is open 2. The fracture is complicated by local tumour deposits 3. The injury is an isolated fracture of the medial malleolus 4. The index injury occurred more than 14 days prior to recruitment 5. They are unable to adhere to trial procedures 6. Previous randomisation in the current trial |
| Recruitment start date | 01/10/2019 |
| Recruitment end date | 05/09/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Bristol
BS1 3NU
United Kingdom
Southport
PR8 6PN
United Kingdom
Whitechapel
London
E1 1BB
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Wrythe Lane
Carshalton
Surrey
SM5 1AA
United Kingdom
Standing Way
Milton Keynes
MK6 5LD
United Kingdom
Cramlington
Northumberland
NE23 6NZ
United Kingdom
Parkfield Drive
Taunton
TA1 5DA
United Kingdom
Oxford Road
Banbury
OX16 9AL
United Kingdom
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Kettering
NN16 8UZ
United Kingdom
Armthorpe Road
Doncaster
DN2 5LT
United Kingdom
Gillingham
ME7 5NY
United Kingdom
NE1 4LP
United Kingdom
Whitefield Road
Dunfermline
Fife
KY12 0SU
United Kingdom
PO30 5TG
United Kingdom
Larbert
FK5 4WR
United Kingdom
Sponsor information
University/education
CTRG
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
England
United Kingdom
| ctrg@admin.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 15/12/2028 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The 12 months results will be presented and published internationally and will inform the NICE ‘non-complex fracture’ recommendations in 2024. Five-year long-term outcomes will be reported in 2027. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Xavier Griffin (x.griffin@qmul.ac.uk). Requests can be made 3 years after the publication of the main trial results. The data would be anonymised. The exact details of the type of data, for what type of analyses and for how long will be determined on a case-by-case basis. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | 07/03/2024 | 06/12/2024 | No | No |
Additional files
Editorial Notes
06/12/2024: Protocol added.
11/10/2023: The following changes were made to the study record:
1. The recruitment end date was changed from 31/08/2023 to 05/09/2023.
2. The overall study end date was changed from 31/08/2028 to 05/09/2028.
3. The intention to publish date was changed from 30/11/2028 to 15/12/2028.
4. Total final enrolment added.
27/07/2023: The following changes were made to the study records:
1. The recruitment end date was changed from 31/07/2023 to 31/08/2023.
2. The overall study end date was changed from 31/07/2028 to 31/08/2028.
3. The intention to publish date was changed from 30/10/2028 to 30/11/2028.
29/06/2023: Contact details updated.
22/06/2023: The following changes were made to the study record and the plain English summary was updated to reflect these changes:
1. The recruitment end date was changed from 30/06/2023 to 31/07/2023.
2. The overall study end date was changed from 30/06/2028 to 31/07/2028.
3. The intention to publish date was changed from 30/09/2028 to 30/10/2028.
04/04/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/04/2023 to 30/06/2023.
2. The overall end date was changed from 30/04/2028 to 30/06/2028.
3. The intention to publish date was changed from 31/07/2028 to 30/09/2028.
4. The plain English summary was updated to reflect these changes.
23/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 30/04/2023.
2. The overall end date was changed from 31/03/2028 to 30/04/2028.
3. The intention to publish date was changed from 30/04/2028 to 31/07/2028.
4. The plain English summary was updated to reflect these changes.
21/03/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/03/2022 to 31/12/2022.
2. The overall trial end date has been changed from 30/06/2027 to 31/03/2028 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/07/2027 to 30/04/2028.
4. IPD sharing statement added.
23/09/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2021 to 31/03/2022.
2. The overall trial end date has been changed from 31/01/2027 to 30/06/2027 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 31/01/2026 to 31/07/2027.
4. the study contact has been updated.
16/02/2021: St Mary's Hospital and Forth Valley Royal Hospital were added as trial participating centres.
16/12/2020: The following changes were made to the trial record:
1. The contact details and the primary outcome measure were updated.
2. Kettering General Hospital, Doncaster Royal Infirmary, Medway Maritime Hospital, Royal Victoria Infirmary and NHS Fife were added as trial participating centres.
24/06/2020: Recruitment to this study is no longer paused.
20/04/2020: Due to current public health guidance, recruitment for this study has been paused.
30/03/2020: The following changes have been made:
1. The trial participating centres "St George's University Hospitals NHS Foundation Trust", "University Hospitals of Leicester NHS Trust", and "The Newcastle Upon Tyne Hospitals NHS Foundation Trust" have been removed.
2. The trial participating centres "Epsom and St Helier University Hospitals NHS Trust", "Milton Keynes University Hospital NHS Foundation Trust", "Northumbria Specialist Emergency Care Hospital", "Taunton and Somerset NHS Foundation Trust", "Oxford University Hospitals NHS Foundation Trust", and "City Hospitals Sunderland NHS Foundation Trust" have been added.
3. A scientific contact has been updated.
23/09/2019: Trial's existence confirmed by the NIHR.
