Idiopathic Clubfoot (Talipes Equinovarus) Clinical Trial
Official title:
A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot
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.
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).
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00152334 -
Efficacy of Botox in Patients With Idiopathic Clubfoot
|
N/A |