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Sponsored by: |
University of British Columbia |
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Information provided by: | University of British Columbia |
ClinicalTrials.gov Identifier: | NCT00474032 |
The purpose of this study is to determine the effectiveness of treatment of idiopathic clubfoot utilizing Botulinum Toxin Type A (Botox). This is not a hypothesis-generating study as we are reporting on outcomes of patients who have been treated by this method of clubfoot treatment.
Condition | Intervention |
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Clubfoot |
Drug: Botulinum Toxin (Type A) injection (10 U/Kg) |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | Efficacy of Botox in Patients With Idiopathic Clubfoot |
Estimated Enrollment: | 2000 |
Study Start Date: | March 2003 |
Estimated Study Completion Date: | March 2023 |
Estimated Primary Completion Date: | March 2023 (Final data collection date for primary outcome measure) |
Subjects with clubfoot will be assessed at the initial visit by Dr. Alvarez. During this visit, the first part of treatment, which is manipulation and casting of the clubfoot will be started. Following this visit, there will be weekly visits for continued manipulation and casting until no further correction of the clubfoot is seen. At this point, (usually after four weeks of casting or when the subject is 6-8 weeks of age), Botox® will be injected into the calf muscles of the affected foot or feet. Before the injection, the patch of skin overlying the intended site(s) of injection will be covered with a local anaesthetic cream (EMLA). This will be applied 30 minutes prior to the injection. This helps numb the skin where the injection will take place. A dose of 10 IU/kg Botox® will be used.
Following the Botox injection another cast will be applied. This will be followed by at least 3 more weekly cast changes to maintain the correction.
After the casting and once the child's foot (feet) are big enough and have achieved a minimum of 15 degrees of ankle dorsiflexion with the knee in flexion, the bracing period will begin. This involves use of boots and bars which are worn fulltime until the child begins to weight-bear (usually occurs between 4 to 6 months of age). Until the child reaches skeletal maturity, there will always be a tendency for the foot to return to its clubbed position. Therefore, continued vigilance is part of the care for clubfoot. The following is the appointment schedule, assuming that there are no recurrences:
If there is a recurrence of clubfoot malposition, manipulation and casting will be reinstated and a possible repeat of injection of Botox® will be administered.
Ages Eligible for Study: | up to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Contact: Harpreet Chhina | 604-875-2000 ext 6008 | hchhina@cw.bc.ca |
Canada, British Columbia | |
BC Children's Hospital | Recruiting |
Vancouver, British Columbia, Canada, V6H 3V4 | |
Contact: Harpreet Chhina 604-875-2000 ext 6008 hchhina@cw.bc.ca |
Principal Investigator: | Christine Alvarez, MD | University of British Columbia |
Responsible Party: | University of British Columbia ( Dr. Christine Alvarez ) |
Study ID Numbers: | H01-70210 |
Study First Received: | May 14, 2007 |
Last Updated: | May 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00474032 History of Changes |
Health Authority: | Canada: Health Canada |
Idiopathic clubfoot Botox injection Idiopathic Talipes Equinovarus, also known as Idiopathic clubfoot |
Botulinum Toxins Musculoskeletal Diseases Talipes Equinovarus Clubfoot |
Equinus Deformity Botulinum Toxin Type A Congenital Abnormalities Foot Deformities |
Foot Deformities, Acquired Botulinum Toxins Musculoskeletal Diseases Anti-Dyskinesia Agents Therapeutic Uses Clubfoot |
Equinus Deformity Central Nervous System Agents Foot Deformities Pharmacologic Actions Foot Deformities, Congenital |