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

NCT ID: NCT03575975

Last Updated: 2021-05-28

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-05-30
• Study Completion Date: 2020-04-16

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.

Conditions

Ankle Arthroplasty; Prosthesis User; Joint Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Mobile-bearing ankle prosthesis user

Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.

Total Ankle Replacement Prosthesis

Intervention Type: DEVICE

Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.

Control

Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.

No interventions assigned to this group

Fixed-bearing ankle prosthesis user

Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.

Total Ankle Replacement Prosthesis

Intervention Type: DEVICE

Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.

Interventions

Total Ankle Replacement Prosthesis

Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Between 18 to 79 years of age.

• Able to walk independently with their prosthesis at different self-selected speeds
• Implanted with Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis at least one year prior to enrollment
• Pain free and radiologically normal
• Able to walk at preferred walking speed without an assistive device (e.g., cane, crutches, etc.)

• Within 3 years of age of one of the mobile-bearing ankle prosthesis user participants
• Same gender as the matched mobile-bearing ankle prosthesis user participant
• Not have a history of major musculoskeletal injuries
• Not have a history of major neuromuscular injuries

• Able to walk independently with their prosthesis at different self-selected speeds
• Implanted with INBONE 2 prosthesis at least one year prior to enrollment
• Pain free and radiologically normal
• Able to walk at preferred walking speed without an assistive device (cane, crutches, etc.)

Exclusion Criteria

• Have dementia or an inability to give informed consent
• Have significant or chronic loss of hip or knee joint motion
• Have any subtalar or hindfoot fusion
• Have a history of dizziness and/or balance problems
• Have had any additional x-ray exposures in the past year that would put beyond the recommended annual dose for the study
• Are pregnant
• Exhibit evidence of polysubsidence (implant loosening)
• Exhibit evidence of a broken implant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

Stryker Orthopaedics

INDUSTRY

Sponsor Role: collaborator

Georgia Institute of Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Young-Hui Chang, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgia Institute of Technology

Locations

Georgia Institute of Technology

Atlanta, Georgia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Ankle XMA Project

Identifier Type: -

Identifier Source: org_study_id