Clinical trial NCT01067651: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clubfoot
Ponseti Method
Talipes Equinovarus
Casting
Lead sponsor: Alberta Children's Hospital
Sponsor class: OTHER
First posted: 2010-02-11
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: number of casts required to correct the clubfoot deformities
timeFrame: 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:
measure: need for percutaneous tendo-achilles tenotomy
measure: total time in casts (weeks)
measure: ease of cast removal
measure: time of cast removal
timeFrame: number of minutes required for each cast removal
measure: method(s) of cast removal
measure: other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
Study officials:
affiliation: IWK Health Centre
name: Jason Howard, MD
role: PRINCIPAL_INVESTIGATOR
References:
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