An Early Phase 1 interventional study of Minimally Invasive Carroll's Technique and Ponseti method in Congenital Clubfoot, sponsored by LiMing. Status unknown at 1 site in China. Open to participants aged 28 Days to 4 Years. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by LiMing · Early Phase 1, Interventional, and Treatment
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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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's planned enrollment of 80 is above the median of 38 across 40 interventional studies indexed under Clubfoot.
Browse Clubfoot studies →This is the only study on the registry with LiMing as lead sponsor.
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Exclusion Criteria:
Minimally Invasive Carroll's Technique
Procedure: Minimally Invasive Carroll's Technique
Ponseti method
Procedure: Ponseti method
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
As a control, Patient will be treated with classical Ponseti method, including multiple steps: manipulative correction, continuous plaster, achilles tendon cutting, fixation.
Dimeglio classification system
evaluate the grade before and after treatment
Time frame: 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
Pirani scoring system
evaluate the grade before and after treatment
Time frame: 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
talocalcaneal angle measurement
evaluate the grade before and after treatment
Time frame: 0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
Plan to share: Undecided
The record gives a start of Jun 2016, a primary completion of Dec 2016 and a completion of Dec 2019. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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