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

Alberta Children's Hospital

Status: Completed

Conditions: Casting; Talipes Equinovarus; Clubfoot; Ponseti Method

Treatments: Device: Plaster of Paris (POP) casting using the Ponseti Method; Device: Semi-Rigid Fiberglass softcast using the Ponseti Method

Study type: Interventional

Funder types: Other

Identifiers

NCT01067651

E-20062

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 1 to 12 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• congenital idiopathic clubfoot

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Plaster of Paris (POP)

Active Comparator group

Treatment:

Device: Plaster of Paris (POP) casting using the Ponseti Method

semi-rigid fiberglass softcast (SRF, 3M Scotchcast)

Active Comparator group

Treatment:

Device: Semi-Rigid Fiberglass softcast using the Ponseti Method