A trial comparing traditional surgical approach with Ilizarov soft tissue distraction in the treatment of clubfoot that has never had prior treatment and will not respond to casting

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16288947

Enrollment

Registered

2017-02-07

Start date

2016-11-01

Completion date

Unknown

Last updated

2018-05-07

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

Conditions

Neglected clubfoot Musculoskeletal Diseases Neglected clubfoot

Interventions

Participants are randomised to one of two groups using sealed envelope randomisation in a 1:1 ratio. Group 1: Participants undergo surgery with Percutaneous soft tissue releases of the tendo Achilles

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age 2-16 2. Neglected clubfoot 3. Idiopathic 4. Not responding to casting

Exclusion criteria

Exclusion criteria: 1. Neuromuscular clubfoot 2. Syndromic clubfeet

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 10/04/2018: Laaveg-Ponseti score (a questionnaire that includes patient assessments of satisfaction, function and pain assessments and physician assessments of foot position motion and gait) at 1 year after treatment Original primary outcome measure: Foot function is measured using the Oxford foot and Ankle score at baseline and 1 year	—

Secondary

Measure	Time frame
Current secondary outcome measures as of 10/04/2018: 1. Footprint area and peak pressures are measured using a pedobarograph at baseline and 1 year 2. Function is assessed using the Roye score and Bangla score at baseline and 1 year 3. Foot function is measured using the Oxford Foot and Ankle Questionnaire (OxFAQ) score at baseline and 1 year Original secondary outcome measures: 1. Footprint area and peak pressures are measured using a pedobarograph at baseline and 1 year 2. Function is assessed using the Roye score and Bangla score at baseline and 1 year	—

Measure

Time frame

Current secondary outcome measures as of 10/04/2018: 1. Footprint area and peak pressures are measured using a pedobarograph at baseline and 1 year 2. Function is assessed using the Roye score and Bangla score at baseline and 1 year 3. Foot function is measured using the Oxford Foot and Ankle Questionnaire (OxFAQ) score at baseline and 1 year Original secondary outcome measures: 1. Footprint area and peak pressures are measured using a pedobarograph at baseline and 1 year 2. Function is assessed using the Roye score and Bangla score at baseline and 1 year

—

Countries

Ethiopia

Outcome results

None listed

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