Weight-bearing in ankle fractures

Weight Bearing in Ankle Fractures. A randomised clinical trial of weight-bearing following operatively treated ankle fracture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12883981

Enrollment

436

Registered

2019-12-10

Start date

2019-12-23

Completion date

Unknown

Last updated

2026-02-16

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

Conditions

Surgically repaired unstable ankle fractures Musculoskeletal Diseases Fracture of ankle

Interventions

Early-weight bearing vs Delayed weight-bearing. Initially patients will be instructed to be non-weight bearing in the immediate two weeks following surgery, as per usual clinical care, to allow the s

participants will be asked to complete the OMAS and a record of any early adverse events made. Additionally, OMAS, EQ-5D-5L, Global rating of change (GRC), Pain self-efficacy questionnaire and Tampa s

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years and above 2. The patient has undergone operative fixation for an unstable ankle fracture 3. Surgery was performed within 14 days of the injury 4. In the opinion of the treating surgeon, the participant might benefit from early weight-bearing 5. Able and willing to give informed consent

Exclusion criteria

Exclusion criteria: 1. A lack of protective sensation (e.g. peripheral neuropathy) 2. Inability to adhere to trial procedures 3. Bilateral operatively treated ankle fractures 4. Already in a trial for ankle fracture 5. The patient has received a hindfoot nail to treat index fracture

Design outcomes

Primary

Measure	Time frame
Ankle function outcomes measured by the Olerud and Molander Score (OMAS) at the 4 month follow-up time-point	—

Secondary

Measure	Time frame
1. OMAS at 6 weeks and 12 months 2. Health related quality of life (EQ-5D-5L) at 6 weeks, 4 months and 12 months 3. Resource use, costs and comparative cost utility (The Work Productivity and Activity Impairment) at 6 weeks, 4 months and 12 months 4. Difference in risk of adverse events (adverse events) 5. Investigate generalisability, acceptability and mechanism of action of the trial and interventions (CRF's, patient and staff interviews) 6 weeks, 12 months	—

Measure

Time frame

1. OMAS at 6 weeks and 12 months 2. Health related quality of life (EQ-5D-5L) at 6 weeks, 4 months and 12 months 3. Resource use, costs and comparative cost utility (The Work Productivity and Activity Impairment) at 6 weeks, 4 months and 12 months 4. Difference in risk of adverse events (adverse events) 5. Investigate generalisability, acceptability and mechanism of action of the trial and interventions (CRF's, patient and staff interviews) 6 weeks, 12 months

—

Countries

England, Northern Ireland, United Kingdom, Wales

Contacts

Public ContactSusan Wagland

wax@ndorms.ox.ac.uk+44 (0)1865 227318

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026