Skip to main content
OpenTrials
Completed

NCT Number: NCT03953430

Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer

Patients with clubfoot treated with the Ponseti method and undergoing Tibialis Anterior tendon transfer from a prospective database are evaluated using gait analysis including the Oxford foot model and compared to a group of healthy children.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

3 year–12 year

Sex eligibility

All sexes

Study type

Observational

About this study

Children with dynamic clubfoot recurrence after initial Ponseti treatment who underwent TATT between 2014 and 2017 are considered for this study. Exclusion criteria are neurological disease, split transfer of the tendon, additional bone or joint invasive surgery, and initial treatment abroad.

Gait analysis, including the Oxford foot model, will be conducted, and the kinematic and kinetic data of the lower extremity will be compared with a group of age-matched healthy children. To comprise a control group for the purpose of collecting gait analysis data of healthy children, employees of our hospital are asked to allow their children to participate in this study.

Patients will undergo gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA). Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children with unilateral or bilateral idiopathic clubfoot treated with the Ponseti method
  • full TATT

Exclusion criteria

  • clubfoot associated with syndromes or neurological diseases
  • initial Treatment elsewhere with more than 3 casts
  • prior joint invasive or bony surgery
  • split transfer of the tibialis anterior tendon

Treatment and study plan

Gait Analysis

Other

Primary outcomes

  1. Changes in forefoot supination in relation to hindfoot after TATT during swing

    Time frame: preoperative (1-21 days) and 6-12 months postoperatively

    The primary outcome measure is forefoot supination in relation to the hindfoot during swing. Changes of forefoot supination during swing after TATT (6-12 months postoperatively) are compared to preoperative values (Oxford foot model). The parameter is a mean value (in degree) of swing phase supination.

    Therefore gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA) will be conducted. Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.

    Analysis will include graphic gait curve analysis as well as statistical analysis of pre- to postoperative changes.

  2. Changes in forefoot adduction in relation to hindfoot after TATT during swing

    Time frame: preoperative (1-21 days) and 6-12 months postoperatively

    Another primary outcome measure is forefoot adduction in relation to the hindfoot during swing. Changes of forefoot adduction during swing after TATT (6-12 months postoperatively) are compared to preoperative values (Oxford foot model). The parameter is a mean value (in degree) of swing phase adduction.

    Therefore gait analysis, including video recordings with a Vicon motion capture system (Vicon, Oxford, UK) with kinetic data collected from three AMTI force plates (Advanced Mechanical Technology, Inc., Watertown, MA) will be conducted. Placement of markers will be a combination of Cleveland (lower extremity), PlugInGait (upper body), and Oxford Foot (movement within the foot) models.

    Analysis will include graphic gait curve analysis as well as statistical analysis of pre- to postoperative changes.

Sponsors and collaborators

Lead sponsor

Orthopedic Hospital Vienna Speising

Other

Registry information

Official study title

Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
May 16, 2019
Registry last updated
May 16, 2019

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.