Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02022267
Other study ID # EK10-218-1210
Secondary ID
Status Completed
Phase N/A
First received December 7, 2013
Last updated December 20, 2013
Start date October 2011
Est. completion date September 2012

Study information

Verified date December 2013
Source Orthopedic Hospital Vienna Speising
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date September 2012
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 12 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Orthopaedic Hospital Speising Vienna

Sponsors (1)

Lead Sponsor Collaborator
Orthopedic Hospital Vienna Speising

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 3D Gait Analysis with foot model 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. 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 No
Secondary Clinical examination Active and passive range of motion (ROM) of the ankle joint measured with a hand-held goniometer. Ability to walk on the heels and on tiptoes. 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 No
Secondary disease-specific instrument questionnaire questionnaire as described in citation 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 No
See also
  Status Clinical Trial Phase
Withdrawn NCT03580746 - Comparison of Ponseti Method Versus Older Treatments in Talipes Equinovarus Through Gait Analysis and Clinical Results
Completed NCT00175708 - Pedobarographic Assessments of Clubfoot Treated Patients
Recruiting NCT06033638 - Video Documented PBS-Score in Children With Clubfoot
Recruiting NCT06050564 - Therapeutic Recommendations Based on Clinical History and Video Documented PBS-Score
Recruiting NCT06050746 - Predictive Value of the PBS-score in Children With Clubfoot
Completed NCT01481324 - Outcomes of Compliance With Brace Wear in Clubfoot N/A
Withdrawn NCT00475631 - Economic Evaluation of Clubfoot Treatment: One Centre's Experience
Completed NCT01088828 - Exploring the Causes of Clubfoot Using Magnetic Resonance Imaging, MRI N/A
Completed NCT02815306 - Polyaxial Brace Fixing for the Treatment of Congenital Clubfoot N/A
Not yet recruiting NCT01050088 - Sucrose Analgesia in Infants Undergoing Casting for Club Foot N/A
Recruiting NCT00474032 - Using Botox to Treat Patients With Idiopathic Clubfoot N/A
Recruiting NCT04564430 - Clonidine for Tourniquet-related Pain in Children Phase 4
Recruiting NCT03249805 - MiracleFeet Foot Abduction Brace Sensor Trial N/A
Recruiting NCT04766684 - Comparison Study of LMX4 Cream Versus J-Tip Needle-Free Injection System With Lidocaine for In-Office PAT for Clubfoot Phase 4
Not yet recruiting NCT04737083 - CGH Array in Bilateral Clubfoot
Completed NCT02395185 - A Randomized Controlled Trial of Three Non-pharmacologic Analgesic Techniques for Casting of Clubfoot Infants N/A
Completed NCT00607191 - Clubfoot DNA Repository N/A
Completed NCT05456737 - Functional Assessment in Children With Clubfoot
Active, not recruiting NCT04693065 - Pronostic Factors of Long Term Outcome in Patients With Clubfoot Treated by the Ponseti Method
Completed NCT03953430 - Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer