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临床试验/NCT03575975
NCT03575975终止不适用

3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Replacement With Stryker STAR Implant

Georgia Institute of Technology1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2018年5月30日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
1
主要终点
Tibiotalar Joint Angle Kinematics

研究概览

简要总结

Patients who have had a total ankle joint replacement surgery typically have limited movement in their ankles possibly due to the fact that commonly used ankle joint prosthetic devices only allow limited axes of motion.

This study will evaluate the ability of a Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis and INBONE 2 fixed-bearing prosthesis to restore triplanar motion in the tibiotalar (ankle) joint following a surgical arthroplasty (total joint replacement) procedure.

3D X-ray video motion analysis will be utilized to quantify range of motion measurements in two groups of ankle prosthesis users and a group of matched control participants.

详细描述

15 study participants will include those using a Stryker STAR prosthesis and a Wright Medical INBONE 2 prosthesis and a group of matched control subjects.

CT scans of lower limb anatomy (ankle-foot complex) will be obtained for all subjects to be converted into 3D bone surface models for use in the joint motion tracking software.

Each participant will participate in one day of data collection with an X-Ray Motion Analysis (XMA) system. High-speed biplanar XMA system will capture video images of the skeletal motions within the foot-ankle complex during normal movement. Subjects will walk and perform controlled movements in the capture volume within the XMA system.

Following data collection, the 3D bone surface models will be mapped to the sagittal (side view), coronal (front view), and axial (top view) plane skeletal motions demonstrated in the collected x-ray videos. Motion tracking data will then be used to accurately animate the 3D bone models to demonstrate the active range of ankle-foot joint motions during voluntary movement and gait.

Resulting range of motion measurements in dorsiflexion/plantarflexion, internal/external rotation, and inversion/eversion will be used to determine the extent to which normal motion in the ankle-foot complex has been restored in ankle prosthesis users.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Tibiotalar Joint Angle Kinematics

时间窗: 1 year

3D range of motions of the tibiotalar (upper ankle) joint were recorded and analyzed using a biplanar x-ray motion analysis system. In particular, joint ranges of motion were tested in terms of dorsiflexion-plantarflexion, internal-external rotation, and inversion-eversion angles.

次要结局

  • Tibiotalar Joint Linear Translation Kinematics(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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