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

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ClinicalTrials.gov Identifier: NCT01067651
Recruitment Status : Completed
First Posted : February 11, 2010
Last Update Posted : February 11, 2010
Sponsor:
Information provided by:
Alberta Children's Hospital

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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  (Clinical Trial)
Actual Enrollment : 30 participants
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

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067651


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

Additional Information:
Publications:
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
ClinicalTrials.gov Identifier: NCT01067651     History of Changes
Other Study ID Numbers: E-20062
First Posted: February 11, 2010    Key Record Dates
Last Update Posted: February 11, 2010
Last Verified: April 2007

Additional relevant MeSH terms:
Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities