Ankle Arthroplasty, Joint Disease, Prosthesis User
Conditions
Keywords
x-ray motion analysis, joint kinematics, functional range of motion
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.
Interventions
DEVICETotal 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.
Sponsors
Emory University
Stryker Orthopaedics
Georgia Institute of Technology
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mobile-bearing Ankle Prosthesis User 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. | 4 |
| Fixed-bearing Ankle Prosthesis User 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. | 5 |
| Control 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. | 0 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User | Total |
|---|---|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 12.6 | 70.0 years STANDARD_DEVIATION 7.5 | 69.0 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 5 Participants | 9 Participants |
| Region of Enrollment United States | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 |
| other Total, other adverse events | 0 / 3 | 0 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 |
Outcome results
Primary
Tibiotalar Joint Angle Kinematics
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
Population: All participants who completed all aspects of the study protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile-bearing Ankle Prosthesis User | Tibiotalar Joint Angle Kinematics | Dorsiflexion-Plantarflexion Angle | 6.74 degrees | Standard Deviation 2.04 |
| Mobile-bearing Ankle Prosthesis User | Tibiotalar Joint Angle Kinematics | Inversion-Eversion Angle | 5.68 degrees | Standard Deviation 2.81 |
| Mobile-bearing Ankle Prosthesis User | Tibiotalar Joint Angle Kinematics | Internal-External Rotation Angle | 6.28 degrees | Standard Deviation 4.51 |
| Fixed-bearing Ankle Prosthesis User | Tibiotalar Joint Angle Kinematics | Inversion-Eversion Angle | 4.51 degrees | Standard Deviation 2.13 |
| Fixed-bearing Ankle Prosthesis User | Tibiotalar Joint Angle Kinematics | Dorsiflexion-Plantarflexion Angle | 7.47 degrees | Standard Deviation 4.05 |
| Fixed-bearing Ankle Prosthesis User | Tibiotalar Joint Angle Kinematics | Internal-External Rotation Angle | 7.39 degrees | Standard Deviation 3.63 |
Secondary
Tibiotalar Joint Linear Translation Kinematics
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
Population: All participants who completed all aspects of the study protocol.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mobile-bearing Ankle Prosthesis User | Tibiotalar Joint Linear Translation Kinematics | Antero-posterior axis | 0.68 mm | Standard Deviation 1.44 |
| Mobile-bearing Ankle Prosthesis User | Tibiotalar Joint Linear Translation Kinematics | Medio-Lateral axis | 0.60 mm | Standard Deviation 1.41 |
| Mobile-bearing Ankle Prosthesis User | Tibiotalar Joint Linear Translation Kinematics | Superior-Inferior axis | 0.28 mm | Standard Deviation 0.3 |
| Fixed-bearing Ankle Prosthesis User | Tibiotalar Joint Linear Translation Kinematics | Antero-posterior axis | 1.47 mm | Standard Deviation 2.07 |
| Fixed-bearing Ankle Prosthesis User | Tibiotalar Joint Linear Translation Kinematics | Medio-Lateral axis | 1.13 mm | Standard Deviation 1.49 |
| Fixed-bearing Ankle Prosthesis User | Tibiotalar Joint Linear Translation Kinematics | Superior-Inferior axis | 0.20 mm | Standard Deviation 0.13 |