Clubfoot Clinical Trial
Official title:
Normalization of Forefoot Supination After Tibialis Anterior Tendon Transfer for Dynamic Clubfoot Recurrence
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 |
Verified date | May 2019 |
Source | Orthopedic Hospital Vienna Speising |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Orthopedic Hospital Vienna Speising |
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
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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