Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee (VSI-001)
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|ClinicalTrials.gov Identifier: NCT01695720|
Recruitment Status : Completed
First Posted : September 28, 2012
Last Update Posted : May 31, 2013
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|
|Meniscus Tears Loose Bodies Articular Osteoarthritis Articular or Capsular Trauma||Procedure: VisionScope Imaging (VSI) Exam|
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)|
|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|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
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.
- 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.
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 ClinicalTrials.gov 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|
|Principal Investigator:||Thomas J Gill, IV, MD||Massachusetts General Hospital|