Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03575975
Status:
TERMINATED
Last Update Posted:
2021-05-28
First Post:
2018-06-19
Brief Title:
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
Sponsor:
Georgia Institute of Technology
Organization:
Georgia Institute of Technology
Study Overview
Official Title:
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Replacement With Stryker STAR Implant
Status:
TERMINATED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to lack of funding and unforeseen delays
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 dorsiflexionplantarflexion internalexternal rotation and inversioneversion will be used to determine the extent to which normal motion in the ankle-foot complex has been restored in ankle prosthesis users
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 dorsiflexionplantarflexion internalexternal rotation and inversioneversion will be used to determine the extent to which normal motion in the ankle-foot complex has been restored in ankle prosthesis users
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None