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

Comparison of Two Different Cast Materials for the Treatment of Congenital Idiopathic Clubfoot Using the Ponseti Method: A Prospective Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01067651
Enrollment
30
Registered
2010-02-11
Start date
Unknown
Completion date
Unknown
Last updated
2010-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Casting, Clubfoot, Ponseti Method, Talipes Equinovarus

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.

Interventions

DEVICEPlaster of Paris (POP) casting using the Ponseti Method
DEVICESemi-Rigid Fiberglass softcast using the Ponseti Method

Sponsors

Alberta Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 12 Weeks

Inclusion criteria

* congenital idiopathic clubfoot

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
number of casts required to correct the clubfoot deformitiestime 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

MeasureTime frame
total time in casts (weeks)
ease of cast removal
need for percutaneous tendo-achilles tenotomy
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.
time of cast removalnumber of minutes required for each cast removal

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026