This post-marketing investigation will evaluate the mechanical axis alignment achieved with the ATTUNE Single-Use Instrumentation (SUI) as compared to the mechanical axis alignment achieved with the ATTUNE Reusable Instrumentation (RUI) in primary cemented Total Knee Arthroplasty.
This study is designed as comparative, sequential, non-randomized, multi-center investigation. Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA with single use instruments. The mechanical axis alignment will be assessed at the 3 month follow-up by independent radiographic review.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
88
ATTUNE TKA with ATTUNE RUI
ATTUNE TKA with ATTUNE SUI
Scripps Clinic Torrey Pines
La Jolla, California, United States
Geisinger Wyoming Valley
Wilkes-Barre, Pennsylvania, United States
Spire Liverpool Hospital
Liverpool, United Kingdom
Clifton Park Hospital
York, United Kingdom
Difference in Absolute Mechanical Axis Alignment Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time frame: 3 Months Post Surgery
Femoral Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time frame: 3 Months Post Surgery
Tibial Component Varus Valgus Angle Between Subjects Operated on With RUI and SUI TKA Instrumentation
Time frame: 3 Months Post Surgery
Femoral Component Flexion Angle Between Subjects Operated on With RUI and SUI Instrumentation
Time frame: 3 Months Post Surgery
Posterior Tibial Slope Between Subjects Operated on With RUI and SUI Instrumentation
Time frame: 3 Months Post Surgery
Number of Participants With Treatment-related Adverse Events
Time frame: 3 Months Post Surgery
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