Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03953430
Other study ID # TATT
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date March 30, 2018

Study information

Verified date May 2019
Source Orthopedic Hospital Vienna Speising
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date March 30, 2018
Est. primary completion date January 1, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 3 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gait analysis


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Orthopedic Hospital Vienna Speising

References & 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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 NCT02022267 - Gait Analysis in Ponseti Clubfoot N/A
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