An interventional study of Botox in Idiopathic Clubfoot (Talipes Equinovarus), sponsored by University of British Columbia. Completed at 1 site in Canada. Open to participants aged 1 Day to 2 Years. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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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.
69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.
This study's enrollment of 500 is above the median of 38 across 40 interventional studies indexed under Clubfoot.
Browse Clubfoot studies →University of British Columbia is the lead sponsor of 1,340 studies on the registry; 260 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
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.
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 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
The record gives a start of Sep 2005, a primary completion of Mar 2016 and a completion of Oct 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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