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

• Sponsor: Georgia Institute of Technology (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03575975
• Collaborator: Emory University (Other), Stryker Orthopaedics (Industry)
• Enrollment: 9
• Location: 1
• Actual Duration (Months): 22.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ankle Arthroplasty; Prosthesis User; Joint Disease	Device: Total Ankle Replacement Prosthesis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 9 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: 3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Replacement With Stryker STAR Implant
• Actual Study Start Date: May 30, 2018
• Actual Primary Completion Date: Apr 16, 2020
• Actual Study Completion Date: Apr 16, 2020

Arms and Interventions

Arm	Intervention/Treatment
Mobile-bearing ankle prosthesis user Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.	Device: 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.
Control Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.
Fixed-bearing ankle prosthesis user Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.	Device: 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.

Outcome Measures

Primary Outcome Measures

1. Tibiotalar Joint Angle Kinematics [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.

Secondary Outcome Measures

1. Tibiotalar Joint Linear Translation Kinematics [1 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

INCLUSION CRITERIA:

• Between 18 to 79 years of age.

Additional Inclusion criteria for mobile-bearing ankle prosthesis user group:

• 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.)

Additional Inclusion criteria for control group:

• 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

Additional Inclusion criteria for fixed-bearing ankle prosthesis users:

• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Georgia Institute of Technology	Atlanta	Georgia	United States	30332-0356

Sponsors and Collaborators

• Georgia Institute of Technology
• Emory University
• Stryker Orthopaedics

Investigators

• Principal Investigator: Young-Hui Chang, PhD, Georgia Institute of Technology

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 3, 2018
• Informed Consent Form - Nov 18, 2019

More Information

Publications

None provided.

• Responsible Party: Georgia Institute of Technology
• ClinicalTrials.gov Identifier: NCT03575975
• Other Study ID Numbers: Ankle XMA Project
• First Posted: Jul 3, 2018
• Last Update Posted: May 28, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Georgia Institute of Technology: x-ray motion analysis; joint kinematics; functional range of motion
• Additional relevant MeSH terms: Joint Diseases

Study Results

Participant Flow

Arm/Group Title	Mobile-bearing Ankle Prosthesis User	Fixed-bearing Ankle Prosthesis User	Control
Arm/Group Description	Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis. 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.	Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis. 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.	Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.
Period Title: Overall Study
STARTED	4	5	0
COMPLETED	3	5	0
NOT COMPLETED	1	0	0

Baseline Characteristics

Arm/Group Title	Mobile-bearing Ankle Prosthesis User	Fixed-bearing Ankle Prosthesis User	Control	Total
Arm/Group Description	Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis. 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.	Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis. 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.	Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group. No participants were enrolled due to premature study termination.	Total of all reporting groups
Overall Participants	4	5	0	9
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	67.8 (12.6)	70.0 (7.5)	69.0 (9.5)
Sex: Female, Male (Count of Participants)
Female	3 75%	3 60%	6 Infinity
Male	1 25%	2 40%	3 Infinity
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 NaN
Not Hispanic or Latino	0 0%	0 0%	0 NaN
Unknown or Not Reported	4 100%	5 100%	9 Infinity
Region of Enrollment (participants) [Number]
United States	4 100%	5 100%	9 Infinity

Outcome Measures

1. Primary Outcome

Title	Tibiotalar Joint Angle Kinematics
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All participants who completed all aspects of the study protocol.

Arm/Group Title	Mobile-bearing Ankle Prosthesis User	Fixed-bearing Ankle Prosthesis User
Arm/Group Description	Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis. 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.	Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis. 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.
Measure Participants	3	5
Dorsiflexion-Plantarflexion Angle	6.74 (2.04)	7.47 (4.05)
Internal-External Rotation Angle	6.28 (4.51)	7.39 (3.63)
Inversion-Eversion Angle	5.68 (2.81)	4.51 (2.13)

2. Secondary Outcome

Title	Tibiotalar Joint Linear Translation Kinematics
Description	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.
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

All participants who completed all aspects of the study protocol.

Arm/Group Title	Mobile-bearing Ankle Prosthesis User	Fixed-bearing Ankle Prosthesis User
Arm/Group Description	Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis. 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.	Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis. 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.
Measure Participants	3	5
Antero-posterior axis	0.68 (1.44)	1.47 (2.07)
Medio-Lateral axis	0.60 (1.41)	1.13 (1.49)
Superior-Inferior axis	0.28 (0.30)	0.20 (0.13)

Adverse Events

Time Frame	Adverse event data were collected only during the period of study participation (typically less than 1 week).
Arm/Group Title	Mobile-bearing Ankle Prosthesis User		Fixed-bearing Ankle Prosthesis User
Arm/Group Description	Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis. 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.		Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis. 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.
All Cause Mortality
	Mobile-bearing Ankle Prosthesis User		Fixed-bearing Ankle Prosthesis User
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/5 (0%)
Serious Adverse Events
	Mobile-bearing Ankle Prosthesis User		Fixed-bearing Ankle Prosthesis User
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/5 (0%)
Other (Not Including Serious) Adverse Events
	Mobile-bearing Ankle Prosthesis User		Fixed-bearing Ankle Prosthesis User
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/5 (0%)

Limitations/Caveats

An early termination of the study led to a smaller number of subjects enrolled/analyzed than originally planned.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.