Sponsor study identifier
interventional
80
1 country
1
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2019
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
June 21, 2016
Actual (reported)June 28, 2016
Actual (reported)December 2016
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Dimeglio classification system
evaluate the grade before and after treatment
0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
Pirani scoring system
0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
talocalcaneal angle measurement
0 month(before treatment); 3rd month, 1st year, 3rd year(after treatment)
Minimally Invasive Carroll's Technique
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.
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400014, 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.
Ming Li, master
Children's Hospital of Chongqing Medical University
First Submitted
June 21, 2016
First Posted
June 28, 2016
Study Start
June 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
June 28, 2016
Record last verified: 2016-06
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