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

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ClinicalTrials.gov Identifier: NCT03953430
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Christof Radler, 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.

Condition or disease Intervention/treatment
Clubfoot Other: Gait analysis

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.


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Study Type : Observational
Actual Enrollment : 17 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : March 30, 2018

Group/Cohort Intervention/treatment
study group
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.
Other: Gait analysis
control group
healthy children of employees of our hospital
Other: Gait analysis



Primary Outcome Measures :
  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.




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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with dynamic clubfoot recurrence with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953430


Sponsors and Collaborators
Orthopedic Hospital Vienna Speising
Investigators
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Study Director: Christof Radler, MD Orthopedic Hospital Vienna Speising

Publications:
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Responsible Party: Christof Radler, Christof Radler, MD (Head of Pediatric Orthopaedic Team), Orthopedic Hospital Vienna Speising
ClinicalTrials.gov Identifier: NCT03953430     History of Changes
Other Study ID Numbers: TATT
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Christof Radler, Orthopedic Hospital Vienna Speising:
Tibialis anterior tendon transfer
Oxford foot model
gait analysis

Additional relevant MeSH terms:
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Clubfoot
Talipes
Equinus Deformity
Foot Deformities, Acquired
Foot Deformities
Musculoskeletal Diseases
Foot Deformities, Congenital
Lower Extremity Deformities, Congenital
Limb Deformities, Congenital
Musculoskeletal Abnormalities
Congenital Abnormalities