Management of ankle fractures in children

Management of ANkle fractures in CHildren: the feasibility Of a Randomised controlled trial (ANCHOR)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29688616

Enrollment

156

Registered

2020-11-20

Start date

2020-12-10

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

Injuries to the knee and lower leg Musculoskeletal Diseases

Interventions

A feasibility multi-centre parallel group trial with 1:1:1 allocation of patients to removable splint treatment with a brace or bandage or below knee cast. The trial will collect outcome data at 6 and

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Aged 5-15 years inclusive 2. Proven low-risk ankle fracture on x-ray: minimally displaced or undisplaced fibular fracture 3. A clinical undisplaced fracture which fulfils the Ottawa criteria: 3.1. A history of trauma 3.2. Tenderness at the posterior edge of the lateral malleolus 3.3. Unable to weight bear for more than 4 steps 3.4. No alternative cause of pain identified on x-ray

Exclusion criteria

Exclusion criteria: 1. Additional injuries 2. Injury is more than 7 days old at recruitment 3. Current medical condition that prevents the use of any of the treatments (e.g. dermatitis, vasculitis, congenital foot or ankle deformities) 4. In conjunction with their parents are unable to complete the outcome measures chosen in English

Design outcomes

Primary

Measure	Time frame
Feasibility outcome measures: 1. Recruitment rates compared to site screening logs as the number of eligible participants who are randomized in the study 2. Retention rates, drop out and crossovers as a proportion of recruited patients who complete the study regime 3. Adherence to treatments measured using a patient diary for 14 days of treatment 4. Trial experience and qualitative feedback from participants collected through structured interviews with a sample of participants at 12-24 weeks	—

Measure

Time frame

Feasibility outcome measures: 1. Recruitment rates compared to site screening logs as the number of eligible participants who are randomized in the study 2. Retention rates, drop out and crossovers as a proportion of recruited patients who complete the study regime 3. Adherence to treatments measured using a patient diary for 14 days of treatment 4. Trial experience and qualitative feedback from participants collected through structured interviews with a sample of participants at 12-24 weeks

—

Secondary

Measure	Time frame
1. Physical function measured by ASK-P, PROMIS Mobility at 6 and 12 weeks 2. Quality of life measured by EQ-5D-Y and PedsQL4.0 at 6 and 12 weeks 3. Global rating of change score at 6 and 12 weeks 4. Daily pain scores measured using a patient diary for 14 days of treatment 5. Re-injury rates measured using a self-reported questionnaire at 6 and 12 weeks 6. Complications measured using a self-reported questionnaire at 6 and 12 weeks	—

Measure

Time frame

1. Physical function measured by ASK-P, PROMIS Mobility at 6 and 12 weeks 2. Quality of life measured by EQ-5D-Y and PedsQL4.0 at 6 and 12 weeks 3. Global rating of change score at 6 and 12 weeks 4. Daily pain scores measured using a patient diary for 14 days of treatment 5. Re-injury rates measured using a self-reported questionnaire at 6 and 12 weeks 6. Complications measured using a self-reported questionnaire at 6 and 12 weeks

—

Countries

England, United Kingdom

Outcome results

None listed

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