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

Completed

• Conditions: eglected clubfoot; Musculoskeletal Diseases; Neglected clubfoot

• Registration Number: ISRCTN16288947
• Lead Sponsor: CURE International UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-02-07
• Last Update Posted: 7 May 2018
• Study Completion: 2019-01-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

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

Exclusion Criteria

1. Neuromuscular clubfoot
2. Syndromic clubfeet

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 10/04/2018:<br>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<br><br>Original primary outcome measure:<br>Foot function is measured using the Oxford foot and Ankle score at baseline and 1 year

Secondary Outcome Measures

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