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3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty

Terminated
Conditions
Ankle Arthroplasty
Prosthesis User
Joint Disease
Interventions
Device: Total Ankle Replacement Prosthesis
Registration Number
NCT03575975
Lead Sponsor
Georgia Institute of Technology
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
9
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Mobile-bearing ankle prosthesis userTotal Ankle Replacement ProsthesisUsers of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.
Fixed-bearing ankle prosthesis userTotal Ankle Replacement ProsthesisUsers of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.
Primary Outcome Measures
NameTimeMethod
Tibiotalar Joint Angle Kinematics1 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.

Secondary Outcome Measures
NameTimeMethod
Tibiotalar Joint Linear Translation Kinematics1 year

3D range of linear motions of the tibiotalar (upper ankle) joint were recorded and analyzed using a biplanar x-ray motion analysis system. In particular, linear joint ranges of motion were tested in terms of the anteroposterior, mediolateral, and superior-inferior axes.

Trial Locations

Locations (1)

Georgia Institute of Technology

🇺🇸

Atlanta, Georgia, United States

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