Efficacy of Botox in Patients With Idiopathic Clubfoot - Full Text View

Sponsor:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00152334

Purpose

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.

Condition	Intervention
Idiopathic Clubfoot (Talipes Equinovarus)	Drug: Botox

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction

Resource links provided by NLM:

MedlinePlus related topics: Botox

U.S. FDA Resources

Further study details as provided by University of British Columbia:

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. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	September 2005
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

Eligibility

Ages Eligible for Study:	up to 2 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152334

Locations

Canada, British Columbia
BC Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, Canada, V6H 3V4

Sponsors and Collaborators

University of British Columbia

Investigators

Principal Investigator:

Christine Alvarez, PhD

University of British Columbia

More Information

No publications provided

Responsible Party:	University of British Columbia ( Dr. Christine Alvarez )
Study ID Numbers:	C01-0210, W01-0057
Study First Received:	September 7, 2005
Last Updated:	May 26, 2008
ClinicalTrials.gov Identifier:	NCT00152334 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by University of British Columbia:

Efficacy study
assessment of patient outcomes following treatment

Additional relevant MeSH terms:

Foot Deformities, Acquired
Musculoskeletal Diseases
Physiological Effects of Drugs
Clubfoot
Neuromuscular Agents
Equinus Deformity

Peripheral Nervous System Agents
Botulinum Toxin Type A
Foot Deformities
Pharmacologic Actions
Foot Deformities, Congenital

ClinicalTrials.gov processed this record on February 08, 2010