Ankle ArthroplastyNCT03575975
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
An observational study of Ankle Arthroplasty and Prosthesis User, run by Georgia Institute of Technology at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Arthroplasty, Prosthesis User, Joint Disease
- What is being tested?
- Total Ankle Replacement Prosthesis
- Type of treatment
- Medical device
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2018to 16 Apr 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.)
Show all 16Show fewer
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Georgia Institute of Technology
Atlanta, Georgia, 30332-0356
About this study
Official title: 3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Replacement With Stryker STAR Implant
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.
Read the 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
- Being tested
- Total Ankle Replacement Prosthesis
- Keywords
- x-ray motion analysis, joint kinematics, functional range of motion
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Ankle Replacement ProsthesisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile-bearing ankle prosthesis user | Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis. Receives: Device: Total Ankle Replacement Prosthesis | |
| 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. Receives: Device: Total Ankle Replacement Prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2018
- Study start30 May 2018
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Why it stopped: Study was terminated due to lack of funding and unforeseen delays.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ankle ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Georgia Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, Stryker Orthopaedics
- Responsible party
- Sponsor
- Investigators
- Young-Hui Chang, PhD, Principal investigator, Georgia Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575975
- Sponsor's protocol ID
- Ankle XMA Project
- Status last verified
- May 2021
- First submitted
- 19 Jun 2018
- Last updated
- 28 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Replacement With Stryker STAR Implant
- ClinicalTrials.gov ID
- NCT03575975
- Acronym / sponsor ID
- Ankle XMA Project
- Conditions
- Ankle Arthroplasty, Prosthesis User, Joint Disease
- Keywords
- x-ray motion analysis, joint kinematics, functional range of motion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was terminated due to lack of funding and unforeseen delays.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Georgia Institute of TechnologyUniversity, hospital or other
- Collaborators
- Emory University, Stryker Orthopaedics
- Study start
- 30 May 2018 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 3 Jul 2018 (actual)
- Results
- Posted 28 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mobile-bearing ankle prosthesis user | – | Device: Total Ankle Replacement ProsthesisUsers of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis. |
| Control | – | –Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group. |
| Fixed-bearing ankle prosthesis user | – | Device: Total Ankle Replacement ProsthesisUsers of the INBONE II Total Ankle Replacement fixed-bearing prosthesis. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (16 listed)
- 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.)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Ankle Replacement ProsthesisComparison 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. | Device | Fixed-bearing ankle prosthesis user, Mobile-bearing ankle prosthesis user |
Primary outcome
Tibiotalar Joint Angle Kinematics
Time frame: 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.
1 secondary outcome
Tibiotalar Joint Linear Translation Kinematics
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Young-Hui Chang, PhD principal investigator
Georgia Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankle Arthroplasty and Prosthesis User, run by Georgia Institute of Technology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tibiotalar Joint Angle Kinematics (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2021.