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
When patients present to a physician[Single Quote]s office with an orthopedic ailment, a thorough clinical evaluation and patient history will be taken. The normal course of treatment will be followed, and patients will be sent for an MRI when clinically indicated as part of the normal standard of care procedures. Based upon the examination and clinical evaluation, subjects will be indicated for surgery (diagnostic arthroscopy, also standard of care).
After patients receive their MRI and consent to have the diagnostic arthroscopy performed, which is standard of care, those who meet the inclusion criteria for the VSI study will be identified and asked to participate and ultimately enroll in the study.
The VSI procedure will be performed following induction of routine anesthesia in the operating room under sterile conditions. Subjects will receive a VSI examination by the study physician. Once the VSI images have been captured, a standard arthroscopy protocol will be followed, with the initial diagnostic imaging occurring in an identical fashion to the VSI procedure. The arthroscopic diagnosis will be recorded using the routine image capture system of the surgical endoscopy system.
The VSI and MRI images will be reviewed and graded by two blinded experts, an orthopedic surgeon unaffiliated with the study sites and a musculoskeletal radiologist. These experts will be blinded to radiological readings and surgical notes and will review the images in a randomized order, with separated readings of each modality. The diagnostic arthroscopy will serve as the gold standard end point for comparison between the VSI and MRI images.
Additionally the study physician will conduct the identical review as described above. Their data will be compared to the blinded panel outcomes for comparative accuracy.
Experimental Procedures: None
Research-specific Procedures: VSI
Standard-of-care Procedures: Arthroscopy as prescribed by physician
Extra Routine Tests: None
Hazardous Materials: None
PRIMARY OUTCOME MEASURES
* Diagnostic accuracy of a VSI study and that of definitive arthroscopy to address positive clinical signs
* Diagnostic accuracy of an MRI [?]study and that of definitive arthroscopy to address positive clinical signs
* Degree of comparative correlation between the two diagnostic modalities
SECONDARY OUTCOME MEASURES
* Economic impact of false positive diagnostic readings
* Impact on practice efficiency utilizing an in-office-based diagnostic modality
For safety analysis: Capture all safety related issues or serious adverse events;
* All post-scope infections attributable to either the VisionScope procedure
or arthroscopic procedure
* VisionScope system equipment failure
For effectiveness analysis: Captured data will be analyzed to determine the incidence of;
* Agreement by MRI and VSI with arthroscopy (TP)
o MRI readings are confirmed by arthroscopy
o VSI findings are confirmed by arthroscopy
* Absence of agreement by MRI and VSI with arthroscopy (FP)
o MRI readings cannot be confirmed by arthroscopy
o VSI findings cannot be confirmed by arthroscopy
* Number of VSI procedures and MRI scans that are of no diagnostic value
due to image quality
Compile a True Positive and False Positive comparison for VSI and MRI findings per patient. Correlate these findings against the diagnostic arthroscopy (Gold Standard) findings to determine diagnostic variability between VSI and MRI. Compute sensitivity and the confidence level that the hypothesis is true.
The following will be studied from April 1, 2012-April 2, 2013
* Suspected meniscal injuries to the knee
* Suspected articular cartilage injuries to the knee