Clinical trial NCT03953430: Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer
Official title: Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clubfoot
Keywords: Tibialis anterior tendon transfer
Oxford foot model
gait analysis
Lead sponsor: Orthopedic Hospital Vienna Speising
Sponsor class: OTHER
First posted: 2019-05-16
Enrollment: 17
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Changes in forefoot supination in relation to hindfoot after TATT during swing
timeFrame: preoperative (1-21 days) and 6-12 months postoperatively
measure: Changes in forefoot adduction in relation to hindfoot after TATT during swing
timeFrame: preoperative (1-21 days) and 6-12 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Orthopedic Hospital Vienna Speising
name: Christof Radler, MD
role: STUDY_DIRECTOR
References:
citation: 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.