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

VisionScope Technologies

Status: Completed

Conditions: Articular Osteoarthritis; Articular or Capsular Trauma; Meniscus Tears; Loose Bodies

Treatments: Procedure: VisionScope Imaging (VSI) Exam

Study type: Interventional

Funder types: Industry

Identifiers

NCT01695720

VisionScope VSI-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 1 patient group

VisionScope Imaging (VSI) Exam

Experimental group

Description:

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.

Treatment:

Procedure: VisionScope Imaging (VSI) Exam