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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
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