A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot
Information source: University of British Columbia
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Idiopathic Clubfoot (Talipes Equinovarus)
Intervention: Botox (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of British Columbia Official(s) and/or principal investigator(s):
Christine Alvarez, PhD, Principal Investigator, Affiliation: University of British Columbia
Overall contact:
Harpreet Chhina, Phone: 604-875-2000, Ext: 6008, Email: hchhina@cw.bc.ca
Summary
The purpose of this study is to continue the work from the previous review study and
determine the effectiveness of Botox in treating patients with idiopathic clubfoot by
comparing outcomes of subjects treated with manipulation and casting plus Botox (treatment
group) to those treated with manipulation and casting plus placebo (control group).
The null hypothesis is that manipulation and casting plus Botox is not an effective
treatment for idiopathic clubfoot. The alternate hypothesis is that manipulation and casting
plus Botox is an effective treatment for idiopathic clubfoot.
Clinical Details
Official title: A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Primary Outcome: Response to study treatment (as indicated by ankle dorsiflexion with knee in flexion of 15 degrees or greater)
Secondary outcome: Patient outcomes collected at every patient visit including:1. Ankle dorsiflexion with knee in extension 2. Plantarflexion 3. Heel bisector scores 4. Occurrence of recurrence
Detailed description:
The study timeline is divided into five phases which have been defined based on experiences
with the previous review and with clubfoot treatment in general. These phases are as
follows: 1) study treatment (Botox injection versus placebo); 2) post-treatment manipulation
and casting; 3) bracing and full-time maintenance; 4) intent-to-treat intervention for
management of first-time non-responders (NR1) and first-time recurrences (Rec1) post-study
treatment; and 5) rescue intervention for management of second-time non-responders (NR2) and
second-time recurrences (Rec2) post intent-to-treat intervention.
We will utilize a double-blind randomized control trial to assess the efficacy of Botox in
the treatment of idiopathic clubfoot. Patients, parents, both participating surgeons, and
members of their clinical and research teams (physiotherapist, occupational therapist,
orthopaedic technologist, orthotist, research assistant) will be blinded to the study group
(Botox group versus control group) each subject belongs in. The pharmacist preparing the
syringes for injection will not be blinded.
Subjects will be randomly assigned to receive either Botox (Treatment group) or placebo
injection (Control group). Subjects in the treatment group will receive Botox injections
dosed at 10 IU/kg prepared by diluting 100 IU of Botox in 1cc of unpreserved saline. If
the child has bilateral clubfoot, the contents will be divided equally for injection into
each gastrocnemius. Placebo injections for the control group will contain unpreserved saline
at 0. 1cc/kg (such that a 4. 5 kg subject will receive 0. 45cc).
Eligibility
Minimum age: N/A.
Maximum age: 2 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. children presenting with idiopathic clubfoot at BC Children's Hospital and Hospital
for Sick Children
2. children ranging in age from 1 day to 2 months old
3. children who have reached hindfoot stall
4. children with complete pre-study data *From protocol, hindfoot stall is defined:
"following initial manipulation and casting of clubfoot, when the forefoot can be
abducted beyond 60 degrees but hindfoot equinus persists, requiring need for further
intervention to correct the clubfoot deformity"
Exclusion Criteria:
Locations and Contacts
Harpreet Chhina, Phone: 604-875-2000, Ext: 6008, Email: hchhina@cw.bc.ca
BC Children's Hospital, Department of Orthopaedics, Vancouver, British Columbia V6H 3V4, Canada; Recruiting
Harpreet Chhina, Phone: 604-875-2000, Ext: 6008, Email: hchhina@cw.bc.ca
Christine Alvarez, PhD, Principal Investigator
Additional Information
Starting date: September 2005
Ending date: September 2008
Last updated: May 26, 2008
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