Efficacy Analysis of Minimally Invasive Carroll's Technique in Treatment of Congenital Idiopathic Clubfoot
Primary Purpose
Congenital Clubfoot
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Minimally Invasive Carroll's Technique
Ponseti method
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Clubfoot focused on measuring congenital clubfoot
Eligibility Criteria
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.
Sites / Locations
- Children's Hospital of Chongqing Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention group
Control group
Arm Description
Minimally Invasive Carroll's Technique
Ponseti method
Outcomes
Primary Outcome Measures
Dimeglio classification system
evaluate the grade before and after treatment
Secondary Outcome Measures
Pirani scoring system
evaluate the grade before and after treatment
Full Information
NCT ID
NCT02815215
First Posted
June 21, 2016
Last Updated
June 23, 2016
Sponsor
LiMing
Collaborators
Hunan Children's Hospital, Shenzhen Children's Hospital, Guangzhou Women and Children's Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02815215
Brief Title
Efficacy Analysis of Minimally Invasive Carroll's Technique in Treatment of Congenital Idiopathic Clubfoot
Official Title
A Retrospective Multicenter Analysis on Treatment of Congenital Idiopathic Clubfoot With Minimally Invasive Carroll's Technique
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
June 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
LiMing
Collaborators
Hunan Children's Hospital, Shenzhen Children's Hospital, Guangzhou Women and Children's Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Clubfoot
Keywords
congenital clubfoot
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Minimally Invasive Carroll's Technique
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Ponseti method
Intervention Type
Procedure
Intervention Name(s)
Minimally Invasive Carroll's Technique
Intervention Description
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
Intervention Name(s)
Ponseti method
Intervention Description
As a control, Patient will be treated with classical Ponseti method, including multiple steps: manipulative correction, continuous plaster, achilles tendon cutting, fixation.
Primary Outcome Measure Information:
Title
Dimeglio classification system
Description
evaluate the grade before and after treatment
Time Frame
0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
Secondary Outcome Measure Information:
Title
Pirani scoring system
Description
evaluate the grade before and after treatment
Time Frame
0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
Other Pre-specified Outcome Measures:
Title
talocalcaneal angle measurement
Description
evaluate the grade before and after treatment
Time Frame
0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Days
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ming Li, master
Phone
86-023-63633321
Email
lm3180@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Hang Liu, doctorate
Phone
86-15923384065
Email
liuhcq@yeah.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ming Li, master
Organizational Affiliation
Children's Hospital of Chongqing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Chongqing Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400014
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhu Yu, bachelor
Phone
86-13752899331
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21946867
Citation
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.
Results Reference
result
Learn more about this trial
Efficacy Analysis of Minimally Invasive Carroll's Technique in Treatment of Congenital Idiopathic Clubfoot
We'll reach out to this number within 24 hrs