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

NCT00152347 | Completed

• 1 other identifier: H05-70384
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Idiopathic Clubfoot (Talipes Equinovarus)

Outcome Measures

Primary Outcomes (1)

• Primary Outcome: Response to study treatment (as indicated by ankle dorsiflexion with knee in flexion of 15 degrees or greater)

Secondary Outcomes (5)

• Patient outcomes collected at every patient visit including:

• 1. Ankle dorsiflexion with knee in extension

• 2. Plantarflexion

• 3. Heel bisector scores

• 4. Occurrence of recurrence

Interventions

Botox DRUG

See Detailed Description

Eligibility Criteria

• Age: 1 Day - 2 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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"

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Clubfoot

Interventions

Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Christine Alvarez, MD, FRCSC, MSc

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 9, 2005
• Study Start: September 1, 2005
• Primary Completion: September 30, 2015
• Study Completion: September 30, 2015
• Last Updated: May 17, 2018

Record last verified: 2018-05

Locations

CA (1)