NCT01695720

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

Trial Comparing VisionScope Imaging (VSI) With Magnetic Resonance Imaging (MRI) in the Diagnosis of Suggestive Clinical Symptoms for Meniscus and Articular Cartilage Injuries in the Knee

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: VisionScope Technologies · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to accumulate efficacy data on VisionScope Imaging (VSI) for pre-operative diagnosis of certain knee injuries (meniscal and articular cartilage injuries). The study will compare VSI's accuracy to MRI's in diagnosing the same injuries. The hypothesis is the VisionScope Imaging system will be able to provide direct visualization and diagnostic images of inside the joint capsule space without fluid distention in the knee. This study will provide valuable feedback on the ability of the VisionScope system to provide physicians with the information they need to make a definitive diagnosis.

Detailed description

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.

Conditions

• Meniscus Tears
• Loose Bodies
• Articular Osteoarthritis
• Articular or Capsular Trauma

Interventions

Type	Name	Description
PROCEDURE	VisionScope Imaging (VSI) Exam	The VisionScope Imaging (VSI) Exam \[the system itself\] is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization, and the capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2012-09-28
• Last updated: 2013-05-31

Locations

7 sites across 1 country: United States