Condition category
Injury, Occupational Diseases, Poisoning
Date applied
23/09/2019
Date assigned
01/10/2019
Last edited
24/06/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 January 2027

Who is funding the study?
NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC)

Who is the main contact?
Dr Susan Wagland,
Susan.wagland@ndorms.ox.ac.uk

Trial website

http://www.ndorms.ox.ac.uk/clinical-trials/current-trials-and-studies/fame

Contact information

Type

Scientific

Primary contact

Dr Susan Wagland

ORCID ID

Contact details

Oxford Trauma Kadoorie Centre
Level 3 John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 223123
Susan.wagland@ndorms.ox.ac.uk

Type

Scientific

Additional contact

Miss Georgia Goodhew

ORCID ID

Contact details

Oxford Trauma Kadoorie Centre
Level 3 John Radcliffe Hospital
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)1865 223123
fame@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 42891

Study information

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

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

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

Study design

Randomised; Interventional; Design type: Treatment, Surgery

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

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

Phase

Drug names

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 trial start date

01/05/2019

Overall trial end date

31/01/2027

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 890; UK Sample Size: 890

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

30/09/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital Headley Way Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

University Hospitals Bristol NHS Foundation Trust
Marlborough Street
Bristol
BS1 3NU
United Kingdom

Trial participating centre

Southport and Ormskirk Hospital NHS Trust
Town Lane
Southport
PR8 6PN
United Kingdom

Trial participating centre

Barts Health NHS Trust
The Royal London Hospital Whitechapel
London
E1 1BB
United Kingdom

Trial participating centre

South Tees Hospitals NHS Foundation Trust
James Cook University Hospital Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Trial participating centre

Epsom and St Helier University Hospitals NHS Trust
St Helier Hospital Wrythe Lane Carshalton
Surrey
SM5 1AA
United Kingdom

Trial participating centre

Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes University Hospital Standing Way
Milton Keynes
MK6 5LD
United Kingdom

Trial participating centre

Northumbria Specialist Emergency Care Hospital
Northumbria Way Cramlington
Northumberland
NE23 6NZ
United Kingdom

Trial participating centre

Taunton and Somerset NHS Foundation Trust
Musgrove Park Hospital Parkfield Drive
Taunton
TA1 5DA
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
Horton General Hospital Oxford Road
Banbury
OX16 9AL
United Kingdom

Trial participating centre

City Hospitals Sunderland NHS Foundation Trust
Sunderland Royal Hospital Kayll Road
Sunderland
SR4 7TP
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

CTRG
Joint Research Office
1st floor
Boundary Brook House
Churchill Drive
Headington
Oxford
OX3 7GB
United Kingdom
-
ctrg@admin.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR127273

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/01/2026

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

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.