Gait Analysis in Children With Clubfoot Treated With Tibialis Anterior Tendon Transfer

Clubfoot Clinical Trial

Official title:

Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953430
• Other study ID #: TATT
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity

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