Efficacy of Botox in Patients With Idiopathic Clubfoot

Study Overview
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Brief Summary
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The purpose of this study was to determine the efficacy of adding Botox injection to serial manipulations and castings in patients with clubfoot. The study hypothesis was that the use of Botox in the setting of serial manipulations and castings is an effective treatment for clubfoot.

Detailed Description
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All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.

Official Title
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Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction

Conditions
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Idiopathic Clubfoot (Talipes Equinovarus)

Intervention / Treatment
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* Drug: Botox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children presenting with idiopathic clubfoot/feet at BC Children's Hospital Children ranging in age from 1 day to 2 years old at initial treatment Children who have had previous intervention for their clubfoot (methods including surgery, Ponseti method, Kite method, physical therapy method) and had a clubfoot recurrence requiring re-intervention

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botox|All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful clubfoot correction from a single Botox injection. This coincides with entrance into Boots and Bars. This was measured 8 weeks following injection. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes of the study as outlined in protocol (include time of measurement) |  | See protocol | 
| Secondary Outcomes: Patient outcomes collected at every patient visit including: |  | See protocol | 
| 1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit) |  | See protocol | 
| 2. Heel Bisector Scores (collected at every visit) |  | See protocol | 
| 3. Pedobarographs (every 6 months from 18 months to 5 years) |  | See protocol | 
| Gait Analysis (every 2 years from 5 years of age until skeletal maturity) |  | See protocol | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Efficacy study, assessment of patient outcomes following treatment