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

This study has been completed.
Sponsor:
Information provided by:
Alberta Children's Hospital
ClinicalTrials.gov Identifier:
NCT01067651
First received: February 10, 2010
Last updated: NA
Last verified: April 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • need for percutaneous tendo-achilles tenotomy [ Designated as safety issue: No ]
  • total time in casts (weeks) [ Designated as safety issue: No ]
  • ease of cast removal [ Designated as safety issue: No ]
  • time of cast removal [ Time Frame: number of minutes required for each cast removal ]
  • method(s) of cast removal [ Designated as safety issue: No ]
  • other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material. [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   up to 12 Weeks
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:

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

Additional relevant MeSH terms:
Clubfoot
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired

ClinicalTrials.gov processed this record on April 17, 2014