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

• Register: ISRCTN
• Last refreshed on: 7 May 2018
• Main ID: ISRCTN16288947
• Date of registration: 07/02/2017
• Prospective Registration: No
• Primary sponsor: CURE International UK
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 01/11/2016
• Target sample size: 25
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN16288947
• Study type: Interventional
• Study design: Randomised controlled trial (Treatment)

Countries of recruitment

Ethiopia

Contacts

• Name: Tim Nunn

Key inclusion & exclusion criteria

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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Neglected clubfoot
Musculoskeletal Diseases
Neglected clubfoot

Intervention(s)

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 in a 3 step manner (Hoke) then the application of the Ilizarov apparatus foot frame. This involves 2 tibial rings and 2 foot 1/2 rings fixed with tensioned wires. The frame is adjusted daily by 1mm and after correction the frame is removed, a long leg cast is applied and 6 weeks later a Tibialis anterior tendon transfer performed.

Group 2: Participants undergo a staged triple arthrodesis. This involves initial soft tissue releases of the posterior tendinous structures and posterior ankle joint capsulotomy, plantar fascia release and abductor hallucis release at the distal tendinous portion. 6 weeks later a triple arthrodesis is performed. This involves bone resection and fusions of the talo-calcaneal, talo-navicular and calcaneao-cuboid joints.

Follow up involves clinic review, pedobarography and questionnaires. And takes place after 1 year.

Primary Outcome(s)

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 Outcome(s)

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

Secondary ID(s)

mosi.nrerc/0084/2015

Source(s) of Monetary Support

CURE International UK

Ethics review

Status:
Approval date:
Contact:

Ethiopian Ministry of Science and Technology National Research Ethics Review Committee (NRERC), 17/12/2015, ref: mosi.nrerc/0084/2015

Results

• Results available: Yes
• Date Completed: 01/01/2019