N/A
Completed N=44
Stereo Radiography of TKA Patella Mechanics
Source: ClinicalTrials.gov NCT02532933 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcomePrimary: Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant. — 29.6; 21.0 degrees
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.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant. |
29.6; 21.0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02532933). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.