Efficacy of Botox in Patients With Idiopathic Clubfoot

Idiopathic Clubfoot (Talipes Equinovarus) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00152334
• Other study ID #: C01-0210
• Secondary ID: W01-0057
• Status: Completed
• Phase: N/A
• Start date: September 2005
• Est. completion date: October 2018

Study information

• Verified date: May 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: October 2018
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Idiopathic Clubfoot (Talipes Equinovarus)

Intervention

Drug:
• Botox
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.

Locations

Country	Name	City	State
Canada	BC Children's Hospital, Department of Orthopaedics	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

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