Idiopathic Clubfoot (Talipes Equinovarus)
Conditions
Keywords
Efficacy study, assessment of patient outcomes following treatment
Brief summary
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
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.
Interventions
DRUGBotox
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.
Sponsors
University of British Columbia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 2 Years
Healthy volunteers
No
Inclusion criteria
1. Children presenting with idiopathic clubfoot/feet at BC Children's Hospital 2. 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Secondary outcomes of the study as outlined in protocol (include time of measurement) | 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 |
| 2. Heel Bisector Scores (collected at every visit) | See protocol |
Countries
Canada
Outcome results
None listed