Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee (VSI-001)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01695720
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : May 31, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Meniscus Tears Loose Bodies Articular Osteoarthritis Articular or Capsular Trauma Procedure: VisionScope Imaging (VSI) Exam Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : June 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
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.

Primary Outcome Measures :
  1. Diagnostic Accuracy [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01695720

United States, California
Kerlan-Jobe Orthopaedic Foundation
Los Angeles, California, United States, 90045
Stanford School of Medicine
Redwood, California, United States, 94063
Santa Monica Orthopaedic & Sports Medicine Group (SMOG)
Santa Monica, California, United States, 90404
United States, Florida
Andrews Research and Education Institute
Gulf Breeze, Florida, United States, 32561
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30329
United States, Texas
University of Texas SouthWestern
Dallas, Texas, United States, 75390
United States, Vermont
Mansfield Orthopaedics (Copley Hospital)
Morrisville, Vermont, United States, 05661
Sponsors and Collaborators
VisionScope Technologies
Principal Investigator: Thomas J Gill, IV, MD Massachusetts General Hospital


Responsible Party: VisionScope Technologies Identifier: NCT01695720     History of Changes
Other Study ID Numbers: VisionScope VSI-001
First Posted: September 28, 2012    Key Record Dates
Last Update Posted: May 31, 2013
Last Verified: May 2013

Keywords provided by VisionScope Technologies:
Knee Injuries
Meniscus Injuries
Articular Cartilage Injuries
Orthopaedic Diagnostic
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases