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

LiMing

Status and phase: Unknown; Early Phase 1

Conditions: Congenital Clubfoot

Treatments: Procedure: Minimally Invasive Carroll's Technique; Procedure: Ponseti method

Study type: Interventional

Funder types: Other

Identifiers

NCT02815215

CHChongqingMU

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 28 days to 4 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

Intervention group

Experimental group

Description:

Minimally Invasive Carroll's Technique

Treatment:

Procedure: Minimally Invasive Carroll's Technique

Control group

Active Comparator group

Description:

Ponseti method

Treatment:

Procedure: Ponseti method