Visionaire™ Versus Standard Instrumentation Safety and Efficacy in Total Knee Arthroplasty (TKA)

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.

Inclusion Criteria:

Patients must meet all of the inclusion criteria.

1. Patient diagnosed with degenerative arthritis of the knee requiring a unilateral
primary TKA.

2. Patient is of legal age to consent and is skeletally mature.

3. Patient is willing to sign and date an ethics-approved consent form.

4. Patient is willing to be available for two-year follow-up postoperatively

Exclusion Criteria:

Patients must not meet any of the exclusion criteria.

1. Patient is known to have poor bone stock making a TKA unjustifiable.

2. Patient is immuno-suppressed.

3. Patient has physical, emotional or neurological conditions that would compromise the
patient's compliance with postoperative rehabilitation and follow-up.

4. Patient is pregnant or may become pregnant during the course of the study.

5. Patient has a history of prior ipsilateral major knee surgery (e.g. arthroplasty,
high tibial osteotomy, or tibial plateau fracture). Minor prior procedures such as
ACL repair, meniscectomy, or arthroscopy are not excluded.

6. Patient has active, localized or systemic infection.

7. Patient is severely overweight (BMI >40).

8. Patient is a prisoner.

9. Subject has a significant MRI (magnetic resonance imaging) exclusion or
contraindication.

10. Patient has had a total joint arthroplasty of the contralateral limb in the last 12
months.