Efficacy of Botox in Patients With Idiopathic Clubfoot

NCT00152334 | Completed

• 2 other identifiers: C01-0210W01-0057
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Clubfoot (Talipes Equinovarus)

Keywords

Efficacy study; assessment of patient outcomes following treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (6)

• Secondary outcomes of the study as outlined in protocol (include time of measurement)

  See protocol

• Secondary Outcomes: Patient outcomes collected at every patient visit including:

  See protocol

• 1. Ankle range of motion (dorsiflexion and plantarflexion) (collected at every visit)

  See protocol

• 2. Heel Bisector Scores (collected at every visit)

  See protocol

• 3. Pedobarographs (every 6 months from 18 months to 5 years)

  See protocol

Interventions

Botox DRUG

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 Criteria

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

You may qualify if:

• 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

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, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• 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: March 1, 2016
• Study Completion: October 1, 2018
• Last Updated: May 18, 2022

Record last verified: 2017-05

Locations

CA (1)