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Using Botox to Treat Patients With Idiopathic Clubfoot

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ClinicalTrials.gov Identifier: NCT00474032
Recruitment Status : Recruiting
First Posted : May 16, 2007
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
University of British Columbia

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Clubfoot Drug: Botulinum Toxin (Type A) injection (10 U/Kg) Not Applicable

Detailed Description:

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:

  • Weekly appointments for 3 - 5 weeks for initial manipulation and casting
  • Botox® injection
  • Weekly appointments for 3 - 4 weeks for casting post Botox® injection or until the foot is big enough to fit in the brace
  • Weekly appointments for 10 weeks (brace wear at this point)
  • Monthly appointments for 9 months (brace wear at this point)
  • Appointments every 6 months until your child reaches 8 years of age
  • Yearly appointments thereafter until your child reaches 14 years or skeletal maturity

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Botox in Patients With Idiopathic Clubfoot
Study Start Date : March 2003
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arms and Interventions
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Intervention Details:
  • Drug: Botulinum Toxin (Type A) injection (10 U/Kg)
    See Detailed Description.

Outcome Measures
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Primary Outcome Measures :
  1. Surgery rate at any point

Secondary Outcome Measures :
  1. Range of motion of treated feet at any follow up

Eligibility Criteria
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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic clubfoot or clubfoot that is not associated with any other neuromuscular disorders or syndromes
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00474032


Contacts
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Contact: Harpreet Chhina 604-875-2000 ext 6008 hchhina@cw.bc.ca

Locations
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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   
Sponsors and Collaborators
University of British Columbia
Investigators
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Principal Investigator: Christine Alvarez, MD University of British Columbia
More Information
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00474032     History of Changes
Other Study ID Numbers: H01-70210
First Posted: May 16, 2007    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Keywords provided by University of British Columbia:
Idiopathic clubfoot
Botox injection
Idiopathic Talipes Equinovarus, also known as Idiopathic clubfoot
Additional relevant MeSH terms:
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Clubfoot
Talipes
Equinus Deformity
Foot Deformities
Foot Deformities, Acquired
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
 Musculoskeletal Abnormalities
Congenital Abnormalities
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs