Congenital Clubfoot Clinical Trial
Official title:
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.
| Status | Recruiting |
| Enrollment | 80 |
| Est. completion date | December 2019 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 4 Years |
| Eligibility |
Inclusion Criteria: - First diagnosed congenital idiopathic clubfoot cases classified as Dimeglio grade ? and ? 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Children's Hospital of Chongqing Medical University | Chongqing | Chongqing |
| Lead Sponsor | Collaborator |
|---|---|
| LiMing | Guangzhou Women and Children's Medical Center, Hunan Children's Hospital, Shenzhen Children's Hospital |
China,
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. Review. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | talocalcaneal angle measurement | evaluate the grade before and after treatment | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | No |
| Primary | Dimeglio classification system | evaluate the grade before and after treatment | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | No |
| Secondary | Pirani scoring system | evaluate the grade before and after treatment | 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment) | No |