An interventional study of Polyaxial brace in Clubfoot, sponsored by Children's Hospital of Chongqing Medical University. Completed. Open to participants aged 1 Day to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-06-28.
Sponsored by Children's Hospital of Chongqing Medical University · Not applicable, Interventional, and Treatment
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Congenital idiopathic clubfoot (CC) is the fifth most common congenital malformation in children. The Ponseti method is an effective protocol for treatment of congenital idiopathic clubfoot. Plaster is essential for the Ponseti treatment. This paper describes a new brace that can be used for the treatment of clubfoot in newborns and infants instead of plaster.
Methods In the orthopedic department of our hospital, 38 infants and newborns, (57 feet) ,all the patients were under the age of 3 months with congenital clubfoot underwent polyaxial braces between Jan, 2011 to Oct ,2013. Polyaxial brace was used for the deformity correction. Then, during the following 1-3 years, the Dennis braces were used during the night in case of recurrence. Prospective follow-up for a mean duration of 25 months (range, 15-36months) was carried out. The efficacy of the treatment was assessed by Pirani's scoring system before and after treatment.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's enrollment of 88 is above the median of 38 across 40 interventional studies indexed under Clubfoot.
Browse Clubfoot studies →Children's Hospital of Chongqing Medical University is the lead sponsor of 35 studies on the registry; 13 are open to participants now.
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0-6 months infants parents would like to cooperate with the doctors.
Exclusion Criteria:
over 6 months.
The infants who were brace group treated by braces which were designed and made by us.
Device: Polyaxial brace
The Polyaxial brace were made by a technician trained by the China National Disabled Persons Federation. For all patients, gypsum models were prepared first, and then braces were fabricated according to the models. The detailed technique was fully in accordance with the Ponseti method.
hindfoot
severity of the posterior crease, emptiness of the heel and rigidity of the equinus
Time frame: 1 month
midfoot
curvature of the lateral border of the foot, severity of the medial crease and position of the lateral part of the head of the talus
Time frame: 1 month
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
The record gives a start of Mar 2011, a primary completion of Oct 2013 and a completion of Oct 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Children's Hospital of Chongqing Medical University