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

Completed

• Conditions: Clubfoot
• Interventions: Other: Gait analysis

• Registration Number: NCT03953430
• Lead Sponsor: Orthopedic Hospital Vienna Speising

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-01-01
• Primary Completion: 2017-01-01
• Study Completion: 2018-03-30
• Status Verified: 2019-05
• Study First Submitted: 2019-05-03
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
control group	Gait analysis	healthy children of employees of our hospital
study group	Gait analysis	Patients with clubfoot recurrence undergoing Tibialis Anterior tendon transfer with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method.

Primary Outcome Measures

Name	Time	Method
Changes in forefoot supination in relation to hindfoot after TATT during swing	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.
Changes in forefoot adduction in relation to hindfoot after TATT during swing	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.