Clinical Trial: Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot in Newborns and Infants

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Children's Hospital of Chongqing Medical University

Current Primary Outcome:

• hindfoot [ Time Frame: 1 month ]
  severity of the posterior crease, emptiness of the heel and rigidity of the equinus
• midfoot [ Time Frame: 1 month ]
  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

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Hospital of Chongqing Medical University

Dates:
Date Received: March 24, 2016
Date Started: March 2011
Date Completion:
Last Updated: June 23, 2016
Last Verified: June 2016