Brief Title
Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method
Official Title
Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial
Brief Summary
The purpose of this study was to determine the influence of cast material on correction of
congenital idiopathic clubfeet using the Ponseti method.
Detailed Description
Congenital idiopathic clubfoot is the most common congenital deformity in children. It can be
a major cause of disability for children, as well as an emotional stress for parents. The
Ponseti method of clubfoot correction, consisting of serial manipulations and casting, is now
the gold standard of treatment. It has traditionally been described using plaster of Paris
(POP) above-knee casts; however, recently semi-rigid fiberglass softcast (SRF, 3M Scotchcast)
has grown in popularity. There are currently no randomized controlled trials to prove its
efficacy with respect to POP.
Study Type
Interventional
Primary Outcome
number of casts required to correct the clubfoot deformities
Secondary Outcome
need for percutaneous tendo-achilles tenotomy
Condition
Clubfoot
Intervention
Plaster of Paris (POP) casting using the Ponseti Method
Study Arms / Comparison Groups
Plaster of Paris (POP)
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
30
Eligibility Criteria
Inclusion Criteria:
- congenital idiopathic clubfoot
Exclusion Criteria:
- positional equinovarus
- teratologic etiologies of clubfoot
- treatment started at another center
- refuse randomization
- do not understand English
Gender
All
Ages
N/A - 12 Weeks
Contacts
Jason Howard, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01067651
Organization ID
E-20062
Study Sponsor
Alberta Children's Hospital
Study Sponsor
Jason Howard, MD, Principal Investigator, IWK Health Centre
Verification Date
April 2007