Congenital Clubfoot
Conditions
Keywords
congenital clubfoot
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.
Interventions
PROCEDUREMinimally 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
PROCEDUREPonseti method
As a control, Patient will be treated with classical Ponseti method, including multiple steps: manipulative correction, continuous plaster, achilles tendon cutting, fixation.
Sponsors
Hunan Children's Hospital
Shenzhen Children's Hospital
Guangzhou Women and Children's Medical Center
LiMing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 4 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dimeglio classification system | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | evaluate the grade before and after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pirani scoring system | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | evaluate the grade before and after treatment |
Other
| Measure | Time frame | Description |
|---|---|---|
| talocalcaneal angle measurement | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | evaluate the grade before and after treatment |
Countries
China
Contacts
Primary ContactMing Li, master
Backup ContactHang Liu, doctorate
Outcome results
None listed