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CompletedNCT03953430Updated May 16, 2019

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

An observational study in Clubfoot, sponsored by Orthopedic Hospital Vienna Speising. Completed. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-16.

Sponsored by Orthopedic Hospital Vienna Speising · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
17
Ages
3 Years to 12 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Clubfoot

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Keywords

  • Tibialis anterior tendon transfer
  • Oxford foot model
  • gait analysis
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In context

Clubfoot

69 studies on the registry are indexed under Clubfoot; 15 are open to participants now.

This study's enrollment of 17 is below the median of 55 across 27 observational studies indexed under Clubfoot.

Browse Clubfoot studies →

Lead sponsor

Orthopedic Hospital Vienna Speising is the lead sponsor of 9 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 12 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
17 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherGait analysis
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What researchers measure

Primary outcomes

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

    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.

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

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

    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.

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

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Mindler GT, Kranzl A, Lipkowski CA, Ganger R, Radler C. Results of gait analysis including the Oxford foot model in children with clubfoot treated with the Ponseti method. J Bone Joint Surg Am. 2014 Oct 1;96(19):1593-9. doi: 10.2106/JBJS.M.01603. PubMed 25274784 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03953430
Lead sponsor
Orthopedic Hospital Vienna Speising
Responsible party
Christof Radler (Christof Radler, MD (Head of Pediatric Orthopaedic Team), Orthopedic Hospital Vienna Speising) — Principal investigator
First posted
May 16, 2019
Start date
Jan 1, 2014
Primary completion
Jan 1, 2017
Completion
Mar 30, 2018
Last update
May 16, 2019

Study contacts

Christof Radler, MD
study director · Orthopedic Hospital Vienna Speising

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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