Comparing a nail placed within the fibula (calf bone) to plates and screws in surgical stabilisation of unstable ankle fractures in adults

A prospective, randomised, controlled, multicentre, international trial comparing the fibular nail with open reduction and internal fixation for unstable ankle fractures in younger patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN54687269

Enrollment

125

Registered

2020-04-14

Start date

2011-09-18

Completion date

Unknown

Last updated

2020-05-25

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

Conditions

Surgical stabilisation of ankle fractures Surgery

Interventions

Participants were randomly allocated to the control or intervention arms using sealed opaque envelope allocation with a ratio of 1:1 in batches of 20. Control: Open reduction and inte

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged =18 to <65 years 2. Unstable fracture of the ankle 3. Within 2 weeks of fracture 4. No ipsilateral injury to the lower limb

Exclusion criteria

Exclusion criteria: 1. Patients unable to give informed consent or those with cognitive impairment 2. Bilateral injuries or ipsilateral injury to the lower limb 3. Pilon fractures 4. Patients unable to comply with follow-up

Design outcomes

Primary

Measure	Time frame
Ankle symptoms after ankle fracture assessed using the Olerud-Molander Ankle Score core (OMAS) at 1 year	—

Secondary

Measure	Time frame
Complications assessed by follow-up examination at 6 weeks, 3 months, 6 months, 1 year and 2 years post-randomisation	—

Countries

Denmark, United Kingdom

Outcome results

None listed

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