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临床试验/NCT03953430
NCT03953430已完成不适用

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

Orthopedic Hospital Vienna Speising0 个研究点目标入组 17 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
主要终点
Changes in forefoot supination in relation to hindfoot after TATT during swing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children with unilateral or bilateral idiopathic clubfoot treated with the Ponseti method
  • full TATT

排除标准

  • 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

结局指标

主要结局

Changes in forefoot supination in relation to hindfoot after TATT during swing

时间窗: preoperative (1-21 days) and 6-12 months postoperatively

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.

Changes in forefoot adduction in relation to hindfoot after TATT during swing

时间窗: preoperative (1-21 days) and 6-12 months postoperatively

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.

次要结局

未报告次要终点

研究者

发起方
Orthopedic Hospital Vienna Speising
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christof Radler

Christof Radler, MD (Head of Pediatric Orthopaedic Team)

Orthopedic Hospital Vienna Speising

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