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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
500
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.
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada
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.
Time frame: 8 weeks
Secondary outcomes of the study as outlined in protocol (include time of measurement)
Time frame: See protocol
Secondary Outcomes: Patient outcomes collected at every patient visit including:
Time frame: See protocol
1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)
Time frame: See protocol
2. Heel Bisector Scores (collected at every visit)
Time frame: See protocol
3. Pedobarographs (every 6 months from 18 months to 5 years)
Time frame: See protocol
Gait Analysis (every 2 years from 5 years of age until skeletal maturity)
Time frame: See protocol
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