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Completed

NCT Number: NCT00152334

Efficacy of Botox in Patients With Idiopathic Clubfoot

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.

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Key information

Conditions

Idiopathic Clubfoot (Talipes Equinovarus) Clubfoot Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Foot Deformities Foot Deformities, Acquired Foot Deformities, Congenital Limb Deformities, Congenital Lower Extremity Deformities, Congenital Musculoskeletal Abnormalities Musculoskeletal Diseases Talipes

Age range

1 day–2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital, Department of Orthopaedics

Vancouver, British Columbia, V6H 3V4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    Time frame: 8 weeks

Secondary outcomes

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

    Time frame: See protocol

  2. Secondary Outcomes: Patient outcomes collected at every patient visit including:

    Time frame: See protocol

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

    Time frame: See protocol

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

    Time frame: See protocol

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

    Time frame: See protocol

  6. Gait Analysis (every 2 years from 5 years of age until skeletal maturity)

    Time frame: See protocol

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Registry information

Official study title

Treatment of Idiopathic Clubfoot Utilizing Botulinum Toxin A: A New Treatment for Correction

Important dates

Study start
2005
Primary completion
2016
Study completion
2018
First posted
Sep 9, 2005
Registry last updated
May 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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