Using Botox to Treat Patients With Idiopathic Clubfoot

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

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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Contacts

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

Locations

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

Principal Investigator:	Christine Alvarez, MD	University of British Columbia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00474032 History of Changes
Other Study ID Numbers:	H01-70210
First Posted:	May 16, 2007
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:

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