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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-12-31

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.

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Detailed Description

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Conditions

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Congenital Clubfoot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

Minimally Invasive Carroll's Technique

Group Type EXPERIMENTAL

Minimally Invasive Carroll's Technique

Intervention Type PROCEDURE

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

Control group

Ponseti method

Group Type ACTIVE_COMPARATOR

Ponseti method

Intervention Type PROCEDURE

As a control, Patient will be treated with classical Ponseti method, including multiple steps: manipulative correction, continuous plaster, achilles tendon cutting, fixation.

Interventions

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Minimally Invasive Carroll's Technique

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

Intervention Type PROCEDURE

Ponseti method

As a control, Patient will be treated with classical Ponseti method, including multiple steps: manipulative correction, continuous plaster, achilles tendon cutting, fixation.

Intervention Type PROCEDURE

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.

Minimum Eligible Age

28 Days

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No