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

This study has been completed.
Information provided by:
Alberta Children's Hospital Identifier:
First received: February 10, 2010
Last updated: NA
Last verified: April 2007
History: No changes posted
The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.

Condition Intervention
Clubfoot Ponseti Method Talipes Equinovarus Casting Device: Plaster of Paris (POP) casting using the Ponseti Method Device: Semi-Rigid Fiberglass softcast using the Ponseti Method

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial

Further study details as provided by Alberta Children's Hospital:

Primary Outcome Measures:
  • number of casts required to correct the clubfoot deformities [ Time Frame: time required for the foot to be ready for a percutaneous tendo-achilles tenotomy (if necessary), or when dorsiflexion of the ankle greater than or equal to 15 degrees (Pirani=0) was achieved ]

Secondary Outcome Measures:
  • need for percutaneous tendo-achilles tenotomy
  • total time in casts (weeks)
  • ease of cast removal
  • time of cast removal [ Time Frame: number of minutes required for each cast removal ]
  • method(s) of cast removal
  • other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.

Enrollment: 30
Arms Assigned Interventions
Active Comparator: Plaster of Paris (POP) Device: Plaster of Paris (POP) casting using the Ponseti Method
Active Comparator: semi-rigid fiberglass softcast (SRF, 3M Scotchcast) Device: Semi-Rigid Fiberglass softcast 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.

Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • congenital idiopathic clubfoot

Exclusion Criteria:

  • positional equinovarus
  • teratologic etiologies of clubfoot
  • treatment started at another center
  • refuse randomization
  • do not understand English
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Please refer to this study by its identifier: NCT01067651

Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8
Sponsors and Collaborators
Alberta Children's Hospital
Principal Investigator: Jason Howard, MD IWK Health Centre
  More Information

Additional Information:
Ponseti I, Morcuende J, Mosca V, Pirani S, Dietz F, Herzenberg J, Weinstein S, Penny N, Michiel Steenbeek. Clubfoot: Ponseti Management Second Edition. Global-HELP publication

Responsible Party: Dr. Jason Howard, IWK Health Centre Identifier: NCT01067651     History of Changes
Other Study ID Numbers: E-20062
Study First Received: February 10, 2010
Last Updated: February 10, 2010

Additional relevant MeSH terms:
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities
Foot Deformities, Acquired processed this record on August 18, 2017