Arthritis Clinical Trials

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.