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

Not Applicable

Completed

• Conditions: Clubfoot; Ponseti Method; Talipes Equinovarus; Casting
• Interventions: Device: Plaster of Paris (POP) casting using the Ponseti Method; Device: Semi-Rigid Fiberglass softcast using the Ponseti Method

• Registration Number: NCT01067651
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2007-04
• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-10
• Last Update Submitted: 2010-02-10
• Study First Posted: 2010-02-11
• Last Update Posted: 2010-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• congenital idiopathic clubfoot

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plaster of Paris (POP)	Plaster of Paris (POP) casting using the Ponseti Method	-
semi-rigid fiberglass softcast (SRF, 3M Scotchcast)	Semi-Rigid Fiberglass softcast using the Ponseti Method	-

Primary Outcome Measures

Name	Time	Method
number of casts required to correct the clubfoot deformities	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

Name	Time	Method
need for percutaneous tendo-achilles tenotomy
total time in casts (weeks)
ease of cast removal
time of cast removal	number of minutes required for each cast removal
method(s) of cast removal
other concerns about the casting material (e.g. appearance, weight, cleaning, water resistance), and complications relating to the casting material.

Trial Locations

Locations (1)

Alberta Children's Hospital; 🇨🇦 Calgary, Alberta, Canada