Using Botox to Treat Patients With Idiopathic Clubfoot

NCT ID: NCT00474032

Last Updated: 2022-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2023-03-31

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.

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.

Conditions

Clubfoot

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Botulinum Toxin (Type A) injection (10 U/Kg)

See Detailed Description.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Idiopathic clubfoot or clubfoot that is not associated with any other neuromuscular disorders or syndromes

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Christine Alvarez

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Harpreet Chhina

Role: CONTACT

hchhina@cw.bc.ca

604-875-2000 ext. 6008

Facility Contacts

Harpreet Chhina

Role: primary

hchhina@cw.bc.ca

604-875-2000 ext. 6008

Other Identifiers

H01-70210

Identifier Type: -

Identifier Source: org_study_id