Efficacy of Botox in Patients With Idiopathic Clubfoot

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Clubfoot (Talipes Equinovarus)
• Intervention / Treatment: Drug: Botox

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.

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 2 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Secondary outcomes of the study as outlined in protocol (include time of measurement)	See protocol
Secondary Outcomes: Patient outcomes collected at every patient visit including:	See protocol
1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)	See protocol
2. Heel Bisector Scores (collected at every visit)	See protocol
3. Pedobarographs (every 6 months from 18 months to 5 years)	See protocol
Gait Analysis (every 2 years from 5 years of age until skeletal maturity)	See protocol

Collaborators and Investigators

• Sponsor: University of British Columbia
• Investigators: Principal Investigator: Christine Alvarez, PhD, University of British Columbia

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Primary Completion (ACTUAL): March 1, 2016
• Study Completion (ACTUAL): October 1, 2018

Study Registration Dates

• First Submitted: September 7, 2005
• First Submitted That Met QC Criteria: September 7, 2005
• First Posted (ESTIMATE): September 9, 2005

Study Record Updates

• Last Update Posted (ACTUAL): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Efficacy study; assessment of patient outcomes following treatment
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity
• Other Study ID Numbers: C01-0210; W01-0057