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

Early Phase 1

• Conditions: Congenital Clubfoot
• Interventions: Procedure: Minimally Invasive Carroll's Technique; Procedure: Ponseti method

• Registration Number: NCT02815215
• Lead Sponsor: LiMing

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-06
• Study Start: 2016-06
• Study First Submitted: 2016-06-21
• Study First Submitted QC: 2016-06-23
• Last Update Submitted: 2016-06-23
• Study First Posted: 2016-06-28
• Last Update Posted: 2016-06-28
• Primary Completion: 2016-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Minimally Invasive Carroll's Technique	Minimally Invasive Carroll's Technique
Control group	Ponseti method	Ponseti method

Primary Outcome Measures

Name	Time	Method
Dimeglio classification system	0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)	evaluate the grade before and after treatment

Secondary Outcome Measures

Name	Time	Method
Pirani scoring system	0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)	evaluate the grade before and after treatment

Trial Locations

Locations (1)

Children's Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China