Efficacy of Botox in Patients With Idiopathic Clubfoot

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00152334
First received: September 7, 2005
Last updated: February 27, 2014
Last verified: February 2014

September 7, 2005
February 27, 2014
September 2005
December 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00152334 on ClinicalTrials.gov Archive Site
  • Secondary outcomes of the study as outlined in protocol (include time of measurement) [ Time Frame: See protocol ] [ Designated as safety issue: No ]
  • Secondary Outcomes: Patient outcomes collected at every patient visit including: [ Time Frame: See protocol ] [ Designated as safety issue: No ]
  • 1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit) [ Time Frame: See protocol ] [ Designated as safety issue: No ]
  • 2. Heel Bisector Scores (collected at every visit) [ Time Frame: See protocol ] [ Designated as safety issue: No ]
  • 3. Pedobarographs (every 6 months from 18 months to 5 years) [ Time Frame: See protocol ] [ Designated as safety issue: No ]
  • Gait Analysis (every 2 years from 5 years of age until skeletal maturity) [ Time Frame: See protocol ] [ Designated as safety issue: No ]
  • 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)
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Idiopathic Clubfoot (Talipes Equinovarus)
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2015
December 2015   (final data collection date for primary outcome measure)

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
Both
up to 2 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00152334
C01-0210, W01-0057
Not Provided
University of British Columbia
University of British Columbia
Not Provided
Principal Investigator: Christine Alvarez, PhD University of British Columbia
University of British Columbia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP