Clinical trial NCT02022267: Gait Analysis in Ponseti Clubfoot
Official title: Results of Gait Analysis Including Oxford Foot Model in Children With Clubfoot Treated With the Ponseti Method
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clubfoot
Keywords: clubfoot
gait analysis
outcome questionaire
Ponseti method
Lead sponsor: Orthopedic Hospital Vienna Speising
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 51
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 a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002

Brief summary: Patients with clubfoot treated with the Ponseti method from a prospective database are evaluated using gait analysis including a foot model and a disease specific instrument score and compared to a group of healthy children.

Detailed description: Patients with a minimum age of three years from a prospective, consecutive database of patients with clubfoot treated with the Ponseti method beginning in 2002 are considered for this study. Thereby patients will typically have a follow up of nearly three to eight years after initial clubfoot correction. Patients with unilateral or bilateral idiopathic clubfoot are included. Patients with clubfoot associated with syndromes or neurological diseases, with mild clubfoot that required fewer than three casts for initial correction, who first presented at an age older than three months, who were living outside of the country, and who were initially treated elsewhere with more than three casts are excluded. An invitation letter to participate in the study was sent out at the end of 2011, with a second letter being sent out three months after the first. After the second letter patients had a time frame of three more months to participate before the study was closed.

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.

Each patient will be physically examined, active and passive range of motion (ROM) of the ankle joint will be measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes will be recorded. The disease-specific instrument questionnaire, which will be blinded for the treating physician will be handed out to fill in.

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:

* unilateral or bilateral idiopathic clubfoot treated with the Ponseti method

Exclusion Criteria:

* clubfoot associated with syndromes or neurological diseases
* mild clubfoot that required fewer than three casts for initial correction
* clubfoot patients that first presented at an age older than three months
* clubfoot patients who were living outside of the Country
* clubfoot patients who were treated elsewhere with more than three casts

Primary outcomes:
measure: 3D Gait Analysis with foot model
timeFrame: once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed
Secondary outcomes:
measure: Clinical examination
timeFrame: once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed
measure: disease-specific instrument questionnaire
timeFrame: once at time of presentation for study specific examination; invitations were sent out end of 2011, a second letter three months after the first. After second letter patients had a time frame of three more months to participate before study was closed
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Orthopaedic Hospital Speising
Study officials:
affiliation: Orthopaedic Hospital Speising
name: Christof Radler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roye BD, Vitale MG, Gelijns AC, Roye DP Jr. Patient-based outcomes after clubfoot surgery. J Pediatr Orthop. 2001 Jan-Feb;21(1):42-9. doi: 10.1097/00004694-200101000-00010.