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

NCT03953430 | Completed

• 1 other identifier: TATT
• Study Type: observational
• Target: 17
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Clubfoot

Keywords

Tibialis anterior tendon transfer; Oxford foot model; gait analysis

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Study Arms (2)

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

Gait analysis OTHER

control group; study group

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Orthopedic Hospital Vienna Speising: lead

Related Publications (1)

• 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.

  PMID: 25274784 BACKGROUND

MeSH Terms

Conditions

Clubfoot

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Officials

• Christof Radler, MD

  Orthopedic Hospital Vienna Speising

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Christof Radler, MD (Head of Pediatric Orthopaedic Team)

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 16, 2019
• Study Start: January 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: March 30, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05