Total Knee Arthroplasty Clinical Trial
Official title:
Influence of Patellar Geometry on Kinematics, Quadriceps Function, and Patient Outcome in Subjects With the Attune PS RP
Verified date | November 2019 |
Source | University of Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Denver | Colorado Joint Replacement, DePuy Synthes |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | One day |
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