Efficacy of Botox in Patients With Idiopathic Clubfoot

Not Applicable

Completed

• Conditions: Idiopathic Clubfoot (Talipes Equinovarus)

• Registration Number: NCT00152334
• Lead Sponsor: University of British Columbia

Brief 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.

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 Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-09
• Primary Completion: 2016-03
• Status Verified: 2017-05
• Study Completion: 2018-10
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
2. Heel Bisector Scores (collected at every visit)	See protocol
1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)	See protocol
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
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

Trial Locations

Locations (1)

BC Children's Hospital, Department of Orthopaedics; 🇨🇦 Vancouver, British Columbia, Canada