A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot - Full Text View

Sponsor:	University of British Columbia
Information provided by:	University of British Columbia
ClinicalTrials.gov Identifier:	NCT00152347

Purpose

The purpose of this study is to continue the work from the previous review study and determine the effectiveness of Botox in treating patients with idiopathic clubfoot by comparing outcomes of subjects treated with manipulation and casting plus Botox (treatment group) to those treated with manipulation and casting plus placebo (control group).

The null hypothesis is that manipulation and casting plus Botox is not an effective treatment for idiopathic clubfoot. The alternate hypothesis is that manipulation and casting plus Botox is an effective treatment for idiopathic clubfoot.

Condition	Intervention
Idiopathic Clubfoot (Talipes Equinovarus)	Drug: Botox

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Double-Blind, Randomized Control Trial Comparing Botulinum Toxin Type A (Botox) and Placebo in the Treatment of Idiopathic Clubfoot

Resource links provided by NLM:

MedlinePlus related topics: Botox

Drug Information available for: Botulinum toxin A Clostridium botulinum toxin

U.S. FDA Resources

Further study details as provided by University of British Columbia:

Primary Outcome Measures:

Primary Outcome: Response to study treatment (as indicated by ankle dorsiflexion with knee in flexion of 15 degrees or greater) [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient outcomes collected at every patient visit including: [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
1. Ankle dorsiflexion with knee in extension [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
2. Plantarflexion [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
3. Heel bisector scores [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
4. Occurrence of recurrence [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Enrollment:	36
Study Start Date:	September 2005
Estimated Study Completion Date:	February 2013
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Intervention Details:

See Detailed Description

Detailed Description:

The study timeline is divided into five phases which have been defined based on experiences with the previous review and with clubfoot treatment in general. These phases are as follows: 1) study treatment (Botox injection versus placebo); 2) post-treatment manipulation and casting; 3) bracing and full-time maintenance; 4) intent-to-treat intervention for management of first-time non-responders (NR1) and first-time recurrences (Rec1) post-study treatment; and 5) rescue intervention for management of second-time non-responders (NR2) and second-time recurrences (Rec2) post intent-to-treat intervention.

We will utilize a double-blind randomized control trial to assess the efficacy of Botox in the treatment of idiopathic clubfoot. Patients, parents, both participating surgeons, and members of their clinical and research teams (physiotherapist, occupational therapist, orthopaedic technologist, orthotist, research assistant) will be blinded to the study group (Botox group versus control group) each subject belongs in. The pharmacist preparing the syringes for injection will not be blinded.

Subjects will be randomly assigned to receive either Botox (Treatment group) or placebo injection (Control group). Subjects in the treatment group will receive Botox injections dosed at 10 IU/kg prepared by diluting 100 IU of Botox in 1cc of unpreserved saline. If the child has bilateral clubfoot, the contents will be divided equally for injection into each gastrocnemius. Placebo injections for the control group will contain unpreserved saline at 0.1cc/kg (such that a 4.5 kg subject will receive 0.45cc).

Eligibility

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

Criteria

Inclusion Criteria:

children presenting with idiopathic clubfoot at BC Children's Hospital and Hospital for Sick Children
children ranging in age from 1 day to 2 months old
children who have reached hindfoot stall
children with complete pre-study data *From protocol, hindfoot stall is defined: "following initial manipulation and casting of clubfoot, when the forefoot can be abducted beyond 60 degrees but hindfoot equinus persists, requiring need for further intervention to correct the clubfoot deformity"

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00152347

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:	Dr. Christine Alvarez, University of British Columbia
ClinicalTrials.gov Identifier:	NCT00152347 History of Changes
Other Study ID Numbers:	H05-70384
Study First Received:	September 7, 2005
Last Updated:	April 12, 2011
Health Authority:	Canada: Health Canada

Additional relevant MeSH terms:

Clubfoot
Equinus Deformity
Foot Deformities, Congenital
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Acquired
Botulinum Toxins, Type A
Botulinum Toxins

Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012