Comparison of Casting Materials for the Treatment of Clubfoot Using the Ponseti Method

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