Degenerative Arthritis of Knee Clinical Trial
Official title:
A Multicenter, Randomized, Clinical Outcome of VISIONAIRE™ Patient Matched Technology vs. Standard Surgical Instrumentation in Total Knee Arthroplasty
The objective of this study is to assess outcomes following TKA, utilizing two surgical techniques. Patients will be randomized to one of two arms: TKA with standard instrumentation and TKA with VISIONAIRE™ patient-matched cutting blocks. Data will be collected at preoperative, operative/discharge, 3 months, 1 year and 2 years after TKA. The secondary objective of this study is to compare the safety, quality of life, and economic outcomes of TKA when these two techniques are utilized. This study does not involve treatment or investigational products, as all components are FDA cleared and are commercially available.
This is a prospective study comparing VISIONAIRE™ to standard TKA instrumentation. The
objective of this study is to evaluate the safety and efficacy of TKA using VISIONAIRE™ when
compared with standard instrumentation, including device survival, improvement in function
and implant alignment after TKA. This study will also document any device-related, surgical
complications and/or adverse radiographic observations.
In contrast with the control group clinical outcomes following TKA completed with VISIONAIRE™
have yet to be assessed. The current investigation will determine if there is any difference
in TKA outcomes when VISIONAIRE™ patient matched technology is utilized versus standard
instrumentation. All patients meeting the inclusion/exclusion criteria specified in this
protocol will be asked to participate in the study. If the patient consents to participate,
they will be enrolled in the study and randomized to one of the two study arms. Patients
requiring TKA will be implanted with Legion, Genesis II or Journey BCS (Smith & Nephew) total
knee implant systems. Standard instrumentation will be used to assist the surgeon in placing
the implant in the control group. In the VISIONAIRE™ group, standard instrumentation will not
be used in the surgery. Patients randomized to the VISIONAIRE™ arm will have an MRI
preoperatively that will be used to create the customized cutting blocks. All patients will
have an x-ray at each postoperative interval.
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