In younger adults with unstable ankle fractures treated with close contact casting, is ankle function not worse than those treated with surgical intervention?

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67007305

Enrollment

890

Registered

2019-10-01

Start date

2019-10-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unstable ankle fractures Injury, Occupational Diseases, Poisoning Fractures of other parts of lower leg

Interventions

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

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, supe

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

England, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026