Back to resultsEfficacy of Botox in Patients With Idiopathic Clubfoot
Primary Purpose
Idiopathic Clubfoot (Talipes Equinovarus)
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Botox
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Clubfoot (Talipes Equinovarus) focused on measuring Efficacy study, assessment of patient outcomes following treatment
Eligibility Criteria
Inclusion Criteria: Children presenting with idiopathic clubfoot/feet at BC Children's Hospital 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
Sites / Locations
- BC Children's Hospital, Department of Orthopaedics
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT00152334
First Posted
September 7, 2005
Last Updated
May 16, 2022
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT00152334
Brief Title
Efficacy of Botox in Patients With Idiopathic Clubfoot
Official Title
Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Clubfoot (Talipes Equinovarus)
Keywords
Efficacy study, assessment of patient outcomes following treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention 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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Secondary outcomes of the study as outlined in protocol (include time of measurement)
Time Frame
See protocol
Title
Secondary Outcomes: Patient outcomes collected at every patient visit including:
Time Frame
See protocol
Title
1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)
Time Frame
See protocol
Title
2. Heel Bisector Scores (collected at every visit)
Time Frame
See protocol
Title
3. Pedobarographs (every 6 months from 18 months to 5 years)
Time Frame
See protocol
Title
Gait Analysis (every 2 years from 5 years of age until skeletal maturity)
Time Frame
See protocol
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Children presenting with idiopathic clubfoot/feet at BC Children's Hospital
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Alvarez, PhD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's Hospital, Department of Orthopaedics
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Botox in Patients With Idiopathic Clubfoot
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