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

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

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.

Study Overview

• Status: Unknown
• Conditions: Congenital Clubfoot
• Intervention / Treatment: Procedure: Minimally Invasive Carroll's Technique; Procedure: Ponseti method

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400014
      • Recruiting
      • Children's Hospital of Chongqing Medical University
      • Contact: Zhu Yu, bachelor; Phone Number: 86-13752899331

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 4 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention group; Minimally Invasive Carroll's Technique	Procedure: 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
ACTIVE_COMPARATOR: Control group; Ponseti method	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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
talocalcaneal angle measurement	evaluate the grade before and after treatment	0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)

Collaborators and Investigators

• Sponsor: LiMing
• Collaborators: Hunan Children's Hospital; Guangzhou Women and Children's Medical Center; Shenzhen Children's Hospital
• Investigators: Principal Investigator: Ming Li, master, Children's Hospital of Chongqing Medical University

Publications and helpful links

General Publications

• Carroll NC. Clubfoot in the twentieth century: where we were and where we may be going in the twenty-first century. J Pediatr Orthop B. 2012 Jan;21(1):1-6. doi: 10.1097/BPB.0b013e32834a99f2.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2016
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: June 21, 2016
• First Submitted That Met QC Criteria: June 23, 2016
• First Posted (ESTIMATE): June 28, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: congenital clubfoot
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity; Foot Deformities
• Other Study ID Numbers: CHChongqingMU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED