An observational study in Ankle Arthroplasty, Prosthesis User and Joint Disease, sponsored by Georgia Institute of Technology. Terminated at 1 site in United States. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-28.
Sponsored by Georgia Institute of Technology · Observational
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.
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.
712 studies on the registry are indexed under Joint Diseases; 127 are open to participants now.
This study's enrollment of 9 is below the median of 100 across 216 observational studies indexed under Joint Diseases.
Browse Joint Diseases studies →Georgia Institute of Technology is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 7 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Study participants meeting the eligibility criteria will be convenience-sampled from within the metro-Atlanta area. Eligible participants with either a STAR or INBONE 2 prosthesis will be identified from among clinical populations treated at the Emory University Hospital. Control group participants will be convenience-sampled from within the metro-Atlanta area.
Additional Inclusion criteria for mobile-bearing ankle prosthesis user group:
Additional Inclusion criteria for control group:
Additional Inclusion criteria for fixed-bearing ankle prosthesis users:
EXCLUSION CRITERIA:
Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.
Device: Total Ankle Replacement Prosthesis
Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.
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.
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
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
| Milestone | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User | Control |
|---|---|---|---|
| Started | 4 | 5 | 0 |
| Completed | 3 | 5 | 0 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Lost to follow-up | 1 | 0 | 0 |
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.
| degrees | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User |
|---|---|---|
| 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 |
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.
| mm | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User |
|---|---|---|
| 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 |
Collected over Adverse event data were collected only during the period of study participation (typically less than 1 week).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mobile-bearing Ankle Prosthesis User | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Fixed-bearing Ankle Prosthesis User | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
Control group participants were not enrolled due to early termination of the study.
| Age, Continuous(years) | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User | Control | Total |
|---|---|---|---|---|
| Mean | 67.8 ± 12.6 | 70.0 ± 7.5 | — | 69.0 ± 9.5 |
| Sex: Female, Male(Participants) | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User | Control | Total |
|---|---|---|---|---|
| Female | 3 | 3 | — | 6 |
| Male | 1 | 2 | — | 3 |
| Ethnicity (NIH/OMB)(Participants) | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User | Control | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | — | 0 |
| Not Hispanic or Latino | 0 | 0 | — | 0 |
| Unknown or Not Reported | 4 | 5 | — | 9 |
| Region of Enrollment(participants) | Mobile-bearing Ankle Prosthesis User | Fixed-bearing Ankle Prosthesis User | Control | Total |
|---|---|---|---|---|
| United States | 4 | 5 | — | 9 |
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Georgia Institute of Technology