Efficacy Analysis of Minimally Invasive Carroll's Technique in Treatment of Congenital Idiopathic Clubfoot

Study Overview
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Brief Summary
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Congenital clubfoot(CCF) is a kind of common congenital foot deformities in children. Though Ponseti method can cure most of the CCF patients, there are still part of patients can not get satisfactory recovery, especially those children classified as Dimeglio grade Ⅲ and Ⅳ. Carroll's technique is considered to be an ideal method of surgical treatment. But the postoperative scar is relatively large, and accordingly the postoperative complications is still common. Based on the clinical practice of the investigator's group, a modification of Carroll's technique, minimally invasive Carroll's technique, was applied. For the Dimeglio grade Ⅲ and Ⅳ CCF, the postoperative excellent and good rate was over 90%. Therefore, the investigator conducted a multicenter randomized controlled trial on treatment of congenital idiopathic clubfoot with minimally invasive Carroll's technique.

Official Title
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A Retrospective Multicenter Analysis on Treatment of Congenital Idiopathic Clubfoot With Minimally Invasive Carroll's Technique

Conditions
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Congenital Clubfoot

Intervention / Treatment
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* Procedure: Minimally Invasive Carroll's Technique
* Procedure: Ponseti method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First diagnosed congenital idiopathic clubfoot cases classified as Dimeglio grade Ⅲ and Ⅳ Exclusion Criteria: Age≤28 days, and Age>4 years. Accompanied by serious diseases of other organs. Children with inherited metabolic disease and connective tissue disease. Clubfoot caused by trauma, cerebral palsy, congenital multiple joint contracture, polio, spina bifida occulta, and clubfoot derived from spinal cord disease.

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Minimally Invasive Carroll's Technique | Procedure: Minimally Invasive Carroll's Technique<br>* Patient will be treated with minimally invasive Carroll's technique by 3 small incisions in the heel, in the medial side of the foot and in the planta pedis, respectively. Long-leg plaster cast fixation was applied for 6-8 weeks<br>|
| Active Comparator: Control group<br>Ponseti method | Procedure: Ponseti method<br>* As a control, Patient will be treated with classical Ponseti method, including multiple steps: manipulative correction, continuous plaster, achilles tendon cutting, fixation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimeglio classification system | evaluate the grade before and after treatment | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pirani scoring system | evaluate the grade before and after treatment | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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congenital clubfoot