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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Clubfoot, Ponseti Method, Talipes Equinovarus, Casting

Intervention / Treatment
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* Device: Plaster of Paris (POP) casting using the Ponseti Method
* Device: Semi-Rigid Fiberglass softcast using the Ponseti Method


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: congenital idiopathic clubfoot Exclusion Criteria: positional equinovarus teratologic etiologies of clubfoot treatment started at another center refuse randomization do not understand English

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plaster of Paris (POP)<br> | Device: Plaster of Paris (POP) casting using the Ponseti Method<br> <br> |
| Active Comparator: semi-rigid fiberglass softcast (SRF, 3M Scotchcast)<br> | Device: Semi-Rigid Fiberglass softcast using the Ponseti Method<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  |  |