Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee

The primary objective of this study is to accumulate efficacy data on the VisionScope
Imaging System (VSI) for pre-operative diagnoses when it is used to provide illumination and
visualization of articular cavities. The study will analyze the VisionScope system's
accuracy compared to MRI in diagnosing and confirming meniscus tears, chondral defects,
loose bodies, minor arthritis, and/or any articular or capsular trauma.

The hypothesis of the study is that the VisionScope System will be able to obtain direct
visualization and diagnostic images of the intercapsular space without fluid distention in
the knee. This study will provide feedback on the ability of the VisionScope system to
potentially eliminate the need for MRI scans. Additionally, a cost-analysis comparison
between the use of VSI vs. MRI for the diagnosis of orthopaedic knee injuries will be
conducted. Finally, the study will help develop an algorithm of potential use for the VSI
system in the management of knee pathologies.

Inclusion Criteria:

- Suspected meniscal injuries to the knee

- Suspected articular cartilage injuries to the knee

Exclusion Criteria:

- Acute traumatic hemarthroses and/or concomitant ligament injury

- Active systemic infection

- Allergy to silicone or any medication used during the procedure

- Enrollment in another pharmacological or medical device study

- Institutionalized persons, prisoners and persons with decisional incapacity

- Investigator's own students and employees