Efficacy of Botox in Patients With Idiopathic Clubfoot

Condition(s) targeted: Idiopathic Clubfoot (Talipes Equinovarus)

Intervention: Botox (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: University of British Columbia

Official(s) and/or principal investigator(s):
Christine Alvarez, PhD, Principal Investigator, Affiliation: University of British Columbia

The purpose of this study was to determine the efficacy of adding Botox injection to serial manipulations and castings in patients with clubfoot. The study hypothesis was that the use of Botox in the setting of serial manipulations and castings is an effective treatment for clubfoot.

Official title: Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Primary outcome: The rate of successful clubfoot correction from a single Botox injection. This coincides with entrance into Boots and Bars. This was measured 8 weeks following injection.

Secondary outcome:

Secondary outcomes of the study as outlined in protocol (include time of measurement)

Secondary Outcomes: Patient outcomes collected at every patient visit including:

1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)

2. Heel Bisector Scores (collected at every visit)

3. Pedobarographs (every 6 months from 18 months to 5 years)

Gait Analysis (every 2 years from 5 years of age until skeletal maturity)

Detailed description: All patients meeting the inclusion criteria will undergo manipulation and casting until hindfoot stall is encountered. Hindfoot stall is defined as forefoot abduction to 60 degrees but persistence of hindfoot equinus. At hindfoot stall, subjects received Botox injections at 10 IU/kg into the gastrosoleus muscle complex. Following injections, subjects were recasted.

Minimum age: N/A. Maximum age: 2 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Children presenting with idiopathic clubfoot/feet at BC Children's Hospital

2. Children ranging in age from 1 day to 2 years old at initial treatment Children who have had previous intervention for their clubfoot (methods including surgery, Ponseti method, Kite method, physical therapy method) and had a clubfoot recurrence requiring re-intervention

BC Children's Hospital, Department of Orthopaedics, Vancouver, British Columbia V6H 3V4, Canada

Starting date: September 2005
Ending date: December 2010
Last updated: May 26, 2008