N/A N=44 Treatment

Stereo Radiography of TKA Patella Mechanics

Total Knee Arthroplasty

Bottom Line

View on ClinicalTrials.gov: NCT02532933 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2019

Primary outcome: Primary: Patellar Flexion Measured as the Relative Angle Between the Femoral and Patellar Components of the Implant. — 29.6; 21.0 degrees

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: DePuy Synthes Attune PS RP (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Denver
Primary completion: Dec 2017

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	—

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.

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

View full record on ClinicalTrials.gov →

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.