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

Not Applicable

Completed

• Conditions: Meniscus Tears; Loose Bodies; Articular Osteoarthritis; Articular or Capsular Trauma
• Interventions: Procedure: VisionScope Imaging (VSI) Exam

• Registration Number: NCT01695720
• Lead Sponsor: VisionScope Technologies

Brief 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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-09-28
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
VisionScope Imaging (VSI) Exam	VisionScope Imaging (VSI) Exam	A VisionScope Imaging (VSI) Exam is diagnostic arthroscopic procedure. Through a natural or surgical opening, an endoscope is inserted through a cannula to illuminate and visualize the interior cavity of a joint.

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	1 day	Diagnostic accuracy will be assessed during the time of the procedure. There will be no patient followup in this study. Radiologists, post procedure, will compare/contrast the diagnostic findings of a patient's MRI, VSI and Dx Arthroscopy.

Trial Locations

Locations (7)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Santa Monica Orthopaedic & Sports Medicine Group (SMOG); 🇺🇸 Santa Monica, California, United States

Andrews Research and Education Institute; 🇺🇸 Gulf Breeze, Florida, United States

Kerlan-Jobe Orthopaedic Foundation; 🇺🇸 Los Angeles, California, United States

University of Texas SouthWestern; 🇺🇸 Dallas, Texas, United States

Stanford School of Medicine; 🇺🇸 Redwood, California, United States

Mansfield Orthopaedics (Copley Hospital); 🇺🇸 Morrisville, Vermont, United States