Skip to main content
OpenTrials
Completed

NCT Number: NCT01067651

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

The purpose of this study was to determine the influence of cast material on correction of congenital idiopathic clubfeet using the Ponseti method.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Clubfoot Casting Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Ponseti Method Talipes Talipes Equinovarus

Age range

1 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • congenital idiopathic clubfoot

Exclusion criteria

  • positional equinovarus
  • teratologic etiologies of clubfoot
  • treatment started at another center
  • refuse randomization
  • do not understand English

Treatment and study plan

Plaster of Paris (POP) casting using the Ponseti Method

Device

Semi-Rigid Fiberglass softcast using the Ponseti Method

Device

Primary outcomes

  1. 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 outcomes

  1. need for percutaneous tendo-achilles tenotomy

  2. total time in casts (weeks)

  3. ease of cast removal

  4. time of cast removal

    Time frame: number of minutes required for each cast removal

  5. method(s) of cast removal

  6. other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.

Sponsors and collaborators

Lead sponsor

Alberta Children's Hospital

Other

Registry information

Official study title

Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial

Important dates

First posted
Feb 11, 2010
Registry last updated
Feb 11, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.