Overview

This trial is active, not recruiting.

Condition idiopathic clubfoot (talipes equinovarus)
Treatment botox
Sponsor University of British Columbia
Start date September 2005
End date June 2016
Trial size 50 participants
Trial identifier NCT00152334, C01-0210, W01-0057

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
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.
time frame: 8 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants up to 2 years old.

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

Additional Information

Official title Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction
Principal investigator Christine Alvarez, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of British Columbia.