Status:
COMPLETED
A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot
Lead Sponsor:
University of British Columbia
Conditions:
Idiopathic Clubfoot (Talipes Equinovarus)
Eligibility:
All Genders
1-2 years
Phase:
NA
Brief Summary
The purpose of this study is to continue the work from the previous review study and determine the effectiveness of Botox in treating patients with idiopathic clubfoot by comparing outcomes of subject...
Detailed Description
The study timeline is divided into five phases which have been defined based on experiences with the previous review and with clubfoot treatment in general. These phases are as follows: 1) study treat...
Eligibility Criteria
Inclusion
- children presenting with idiopathic clubfoot at BC Children's Hospital and Hospital for Sick Children
- children ranging in age from 1 day to 2 months old
- children who have reached hindfoot stall
- children with complete pre-study data \*From protocol, hindfoot stall is defined: "following initial manipulation and casting of clubfoot, when the forefoot can be abducted beyond 60 degrees but hindfoot equinus persists, requiring need for further intervention to correct the clubfoot deformity"
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2015
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00152347
Start Date
September 1 2005
End Date
September 30 2015
Last Update
May 17 2018
Active Locations (1)
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1
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4