Total Knee ArthroplastyNCT02532933
Stereo Radiography of TKA Patella Mechanics
A study testing DePuy Synthes Attune PS RP in people with Total Knee Arthroplasty, run by University of Denver.
Trial summary
The overall purpose is to compare the kinematics and mechanics of medialized dome and anatomic resurfacing through measurement and simulation, and to correlate these findings with patient satisfaction and performance. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- DePuy Synthes Attune PS RP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2017
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and Women Age: 18-80 years
- Unilateral or bilateral total knee replacement with an Attune posterior-stabilized rotating-platform implant including either medialized dome or medialized anatomic patellae
- Minimum 9 months post TKA procedure
Who cannot join
- Concomitant lower extremity injury that continues to cause pain or loss of normal function (70 or greater Knee Society score)
- Inactive or unable to participate for health reasons (40 or greater on the physical component scale and and the mental component scale composite scores of the SF-12 Health Survey)
- Neurologic deficit that affects function or understanding of testing protocol
- Pregnant
- Other participation in a research study involving exposure to x-ray radiation
- body mass index greater than 30
About this study
Official title: Influence of Patellar Geometry on Kinematics, Quadriceps Function, and Patient Outcome in Subjects With the Attune PS RP
The overall purpose is to compare the kinematics and mechanics of medialized dome and anatomic resurfacing through measurement and simulation, and to correlate these findings with patient satisfaction and performance.
Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs using stereo radiography and correlation with patient function as measured by Knee injury and Osteoarthritis Outcome score, Knee Society score, and strength.
Read more
Hypothesis: the anatomic patellar implant will have significantly greater sagittal flexion than the dome implant.
Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact mechanics and loading through the use of subject-specific simulation.
Hypothesis: quadriceps efficiency and moment arm will be greater for the anatomic patellar implant, while loading between the patellar and femoral components will be reduced.
Read the detailed description
Successful function and outcome following total knee arthroplasty (TKA) is partly determined by the restoration of patellofemoral (PF) function and recovery of the quadriceps mechanism of the knee. Patients with TKA often exhibit adaptations in their movement patterns during functional activity that have been attributed to quadriceps strength reduction and activation deficits that may be linked to the mechanics of the reconstructed knee. Changes in the articular geometry with patella resurfacing also affect patellofemoral kinematics, contact mechanics and loading on the patellar bone. While movement adaptations persist in patients with TKA long after knee repair, measurement of the 6 degree-of-freedom (DOF) kinematics of the patellofemoral joint are difficult with traditional motion capture methods. High-speed stereo radiography (HSSR), an advancement of biplane fluoroscopy, enables measurement of bone and implant motion during activity with sub-mm accuracy. The ability to measure and model the kinematics of the knee with this precision can improve understanding of implanted knee mechanics. What's more, acquiring HSSR in synchrony with whole-body measurements (body segment video motion capture, muscle electromyography (EMG), and ground forces) establishes connections between joint-level and whole-body function, and enables creation of subject-specific models of the knee and lower extremity. Integration with modeling is important because it reveals the biomechanical consequences of differences in patellofemoral kinematics.
Previous measurement and modeling comparisons of PF kinematics between dome and anatomic resurfacing designs have revealed differences in patellar sagittal plane flexion that have implications for quadriceps efficiency and patient satisfaction. Quadriceps efficiency is a measure of the effective moment arm of the quadriceps muscles; greater efficiency allows the quadriceps to produce knee extensor torque with less force. Patellar flexion can alter quadriceps efficiency by changing the moment arm of the patellar tendon and the way the patella transmits quadriceps force due to changes in patellofemoral contact. Patient satisfaction may be affected by changes in quadriceps efficiency through increased extensor mechanism strain and changes in load transfer that may be linked to anterior knee pain. While HSSR measurements can elucidate differences in dome and anatomic kinematics, computational modeling is required to determine how kinematic differences affect joint and muscle forces and overall limb functionality.
Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs using stereo radiography and correlation with patient function as measured by Knee injury and Osteoarthritis Outcome score, Knee Society score, and strength. Laboratory measurements will be collected from 22 TKA patients with medialized dome and 22 TKA patients with medialized anatomic patellae. Equal numbers of men and women will be recruited for the study. The angle of the patellar component relative to the femoral component will be measured and compared to reported values in healthy subjects. Correlations will be made with patient outcome scores.
Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact mechanics and loading through the use of subject-specific simulation. Moment arm will be measured in millimeters as the distance from the patellar tendon to the knee joint center of rotation, and compared to values reported for the healthy knee. Quadriceps efficiency will be calculated as the ratio of quadriceps force to patellar tendon force. Patellar contact mechanics are defined as the force and location of force between the patellar and femoral components.
- Conditions
- Total Knee Arthroplasty
- Being tested
- DePuy Synthes Attune PS RP
- Keywords
- Replacement, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DePuy Synthes Attune PS RPDevice
| Study group | Role | What they receive |
|---|---|---|
| Medialized Dome Patella | Active comparator | Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry Receives: Device: DePuy Synthes Attune PS RP |
| Anatomic Patella | Active comparator | Subjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry Receives: Device: DePuy Synthes Attune PS RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant.
Difference between dome and anatomic patellofemoral flexion, which is measured as the relative angle between the femoral and patellar components of the implant.
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionDec 2017
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 Total Knee 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Denver
- Sponsor type
- University, hospital or other
- Collaborators
- DePuy Synthes, Colorado Joint Replacement
- Responsible party
- Principal investigator, Kevin Shelburne, University of Denver
- Investigators
- Kevin Shelburne, PhD, Principal investigator, University of Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532933
- Sponsor's protocol ID
- 779383 2015 Attune Patella
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2015
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Patellar Geometry on Kinematics, Quadriceps Function, and Patient Outcome in Subjects With the Attune PS RP
- ClinicalTrials.gov ID
- NCT02532933
- Acronym / sponsor ID
- 779383 2015 Attune Patella
- Conditions
- Total Knee Arthroplasty
- Keywords
- Replacement, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of DenverUniversity, hospital or other
- Collaborators
- DePuy Synthes, Colorado Joint Replacement
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose is to compare the kinematics and mechanics of medialized dome and anatomic resurfacing through measurement and simulation, and to correlate these findings with patient satisfaction and performance.
Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs using stereo radiography and correlation with patient function as measured by Knee injury and Osteoarthritis Outcome score, Knee Society score, and strength.
Hypothesis: the anatomic patellar implant will have significantly greater sagittal flexion than the dome implant.
Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact mechanics and loading through the use of subject-specific simulation.
Hypothesis: quadriceps efficiency and moment arm will be greater for the anatomic patellar implant, while loading between the patellar and femoral components will be reduced.
Detailed description
Successful function and outcome following total knee arthroplasty (TKA) is partly determined by the restoration of patellofemoral (PF) function and recovery of the quadriceps mechanism of the knee. Patients with TKA often exhibit adaptations in their movement patterns during functional activity that have been attributed to quadriceps strength reduction and activation deficits that may be linked to the mechanics of the reconstructed knee. Changes in the articular geometry with patella resurfacing also affect patellofemoral kinematics, contact mechanics and loading on the patellar bone. While movement adaptations persist in patients with TKA long after knee repair, measurement of the 6 degree-of-freedom (DOF) kinematics of the patellofemoral joint are difficult with traditional motion capture methods. High-speed stereo radiography (HSSR), an advancement of biplane fluoroscopy, enables measurement of bone and implant motion during activity with sub-mm accuracy. The ability to measure and model the kinematics of the knee with this precision can improve understanding of implanted knee mechanics. What's more, acquiring HSSR in synchrony with whole-body measurements (body segment video motion capture, muscle electromyography (EMG), and ground forces) establishes connections between joint-level and whole-body function, and enables creation of subject-specific models of the knee and lower extremity. Integration with modeling is important because it reveals the biomechanical consequences of differences in patellofemoral kinematics.
Previous measurement and modeling comparisons of PF kinematics between dome and anatomic resurfacing designs have revealed differences in patellar sagittal plane flexion that have implications for quadriceps efficiency and patient satisfaction. Quadriceps efficiency is a measure of the effective moment arm of the quadriceps muscles; greater efficiency allows the quadriceps to produce knee extensor torque with less force. Patellar flexion can alter quadriceps efficiency by changing the moment arm of the patellar tendon and the way the patella transmits quadriceps force due to changes in patellofemoral contact. Patient satisfaction may be affected by changes in quadriceps efficiency through increased extensor mechanism strain and changes in load transfer that may be linked to anterior knee pain. While HSSR measurements can elucidate differences in dome and anatomic kinematics, computational modeling is required to determine how kinematic differences affect joint and muscle forces and overall limb functionality.
Aim 1: Comparison of patellofemoral kinematics between dome and anatomic implant designs using stereo radiography and correlation with patient function as measured by Knee injury and Osteoarthritis Outcome score, Knee Society score, and strength. Laboratory measurements will be collected from 22 TKA patients with medialized dome and 22 TKA patients with medialized anatomic patellae. Equal numbers of men and women will be recruited for the study. The angle of the patellar component relative to the femoral component will be measured and compared to reported values in healthy subjects. Correlations will be made with patient outcome scores.
Aim 2: Comparison of dome and anatomic moment arm, quadriceps efficiency, patellar contact mechanics and loading through the use of subject-specific simulation. Moment arm will be measured in millimeters as the distance from the patellar tendon to the knee joint center of rotation, and compared to values reported for the healthy knee. Quadriceps efficiency will be calculated as the ratio of quadriceps force to patellar tendon force. Patellar contact mechanics are defined as the force and location of force between the patellar and femoral components.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medialized Dome Patella | Active comparator | Device: DePuy Synthes Attune PS RPSubjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with a medialized dome component geometry |
| Anatomic Patella | Active comparator | Device: DePuy Synthes Attune PS RPSubjects with total knee arthroplasty using the DePuy Synthes Attune Posterior Stabilized Rotating Platform including patella resurfacing with an anatomic component geometry |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and Women Age: 18-80 years
- Unilateral or bilateral total knee replacement with an Attune posterior-stabilized rotating-platform implant including either medialized dome or medialized anatomic patellae
- Minimum 9 months post TKA procedure
Key exclusion criteria (6 listed)
- Concomitant lower extremity injury that continues to cause pain or loss of normal function (70 or greater Knee Society score)
- Inactive or unable to participate for health reasons (40 or greater on the physical component scale and and the mental component scale composite scores of the SF-12 Health Survey)
- Neurologic deficit that affects function or understanding of testing protocol
- Pregnant
- Other participation in a research study involving exposure to x-ray radiation
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 |
|---|---|---|
| DePuy Synthes Attune PS RP | Device | Anatomic Patella, Medialized Dome Patella |
Primary outcome
Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant.
Time frame: One day
Difference between dome and anatomic patellofemoral flexion, which is measured as the relative angle between the femoral and patellar components of the implant.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Website of the Center for Orthopaedic BiomechanicsLink provided by the sponsor.
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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.
Kevin Shelburne, PhD principal investigator
University of Denver
Questions about this trial
What is this clinical trial studying?
A study testing DePuy Synthes Attune PS RP in people with Total Knee Arthroplasty, run by University of Denver.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
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 27 Nov 2019). 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?
Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant. (time frame: One day). 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 27 Nov 2019.