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| ID | Type | Description | Link |
|---|---|---|---|
| W01-0057 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botox | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Alvarez, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's Hospital, Department of Orthopaedics | Vancouver | British Columbia | V6H 3V4 | Canada |
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| ID | Term |
|---|---|
| D003025 | Clubfoot |
| ID | Term |
|---|---|
| D000070558 | Talipes |
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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| 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 |
| D005532 |
| Foot Deformities, Congenital |
| D038061 | Lower Extremity Deformities, Congenital |
| D017880 | Limb Deformities, Congenital |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |