Clinical Trial: Efficacy of Botox in Patients With Idiopathic Clubfoot

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: University of British Columbia

Current Primary Outcome: 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 ]

Original Primary Outcome: 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.

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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)


Information By: University of British Columbia

Dates:
Date Received: September 7, 2005
Date Started: September 2005
Date Completion: June 2016
Last Updated: May 30, 2016
Last Verified: May 2016