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

Primary Purpose

Meniscus Tears, Loose Bodies, Articular Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VisionScope Imaging (VSI) Exam
Sponsored by
VisionScope Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Meniscus Tears focused on measuring Knee Injuries, Meniscus Injuries, Articular Cartilage Injuries, Orthopaedic Diagnostic, Magnetic Resonance Imaging

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Kerlan-Jobe Orthopaedic Foundation
  • Stanford School of Medicine
  • Santa Monica Orthopaedic & Sports Medicine Group (SMOG)
  • Andrews Research and Education Institute
  • Emory University Hospital
  • University of Texas SouthWestern
  • Mansfield Orthopaedics (Copley Hospital)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VisionScope Imaging (VSI) Exam

Arm 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.

Outcomes

Primary Outcome Measures

Diagnostic Accuracy
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.

Secondary Outcome Measures

Full Information

First Posted
September 13, 2012
Last Updated
May 29, 2013
Sponsor
VisionScope Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT01695720
Brief Title
Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee
Acronym
VSI-001
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 Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VisionScope Technologies

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniscus Tears, Loose Bodies, Articular Osteoarthritis, Articular or Capsular Trauma
Keywords
Knee Injuries, Meniscus Injuries, Articular Cartilage Injuries, Orthopaedic Diagnostic, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VisionScope Imaging (VSI) Exam
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
VisionScope Imaging (VSI) Exam
Intervention Description
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 Measure Information:
Title
Diagnostic Accuracy
Description
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.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas J Gill, IV, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kerlan-Jobe Orthopaedic Foundation
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Stanford School of Medicine
City
Redwood
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
Santa Monica Orthopaedic & Sports Medicine Group (SMOG)
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Facility Name
Andrews Research and Education Institute
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
University of Texas SouthWestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Mansfield Orthopaedics (Copley Hospital)
City
Morrisville
State/Province
Vermont
ZIP/Postal Code
05661
Country
United States

12. IPD Sharing Statement

Citations:
Citation
Rheumatology 2000; 39: 700-706, British Society for Rheumatology
Results Reference
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PubMed Identifier
17279041
Citation
Ryzewicz M, Peterson B, Siparsky PN, Bartz RL. The diagnosis of meniscus tears: the role of MRI and clinical examination. Clin Orthop Relat Res. 2007 Feb;455:123-33. doi: 10.1097/BLO.0b013e31802fb9f3.
Results Reference
background
PubMed Identifier
7489301
Citation
Ruwe PA, McCarthy SM. Cost effectiveness of magnetic resonance imaging of the knee. Magn Reson Imaging Clin N Am. 1994 Aug;2(3):475-9.
Results Reference
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PubMed Identifier
9246993
Citation
Rappeport ED, Wieslander SB, Stephensen S, Lausten GS, Thomsen HS. MRI preferable to diagnostic arthroscopy in knee joint injuries. A double-blind comparison of 47 patients. Acta Orthop Scand. 1997 Jun;68(3):277-81. doi: 10.3109/17453679708996701.
Results Reference
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PubMed Identifier
8804283
Citation
Rangger C, Klestil T, Kathrein A, Inderster A, Hamid L. Influence of magnetic resonance imaging on indications for arthroscopy of the knee. Clin Orthop Relat Res. 1996 Sep;(330):133-42. doi: 10.1097/00003086-199609000-00016.
Results Reference
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PubMed Identifier
18094289
Citation
De Smet AA, Mukherjee R. Clinical, MRI, and arthroscopic findings associated with failure to diagnose a lateral meniscal tear on knee MRI. AJR Am J Roentgenol. 2008 Jan;190(1):22-6. doi: 10.2214/AJR.07.2611.
Results Reference
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PubMed Identifier
19050885
Citation
Halinen J, Koivikko M, Lindahl J, Hirvensalo E. The efficacy of magnetic resonance imaging in acute multi-ligament injuries. Int Orthop. 2009 Dec;33(6):1733-8. doi: 10.1007/s00264-008-0689-6. Epub 2008 Dec 3.
Results Reference
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PubMed Identifier
3535549
Citation
Mandelbaum BR, Finerman GA, Reicher MA, Hartzman S, Bassett LW, Gold RH, Rauschning W, Dorey F. Magnetic resonance imaging as a tool for evaluation of traumatic knee injuries. Anatomical and pathoanatomical correlations. Am J Sports Med. 1986 Sep-Oct;14(5):361-70. doi: 10.1177/036354658601400503.
Results Reference
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PubMed Identifier
18297284
Citation
Rayan F, Bhonsle S, Shukla DD. Clinical, MRI, and arthroscopic correlation in meniscal and anterior cruciate ligament injuries. Int Orthop. 2009 Feb;33(1):129-32. doi: 10.1007/s00264-008-0520-4. Epub 2008 Feb 23.
Results Reference
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PubMed Identifier
20406481
Citation
von Engelhardt LV, Lahner M, Klussmann A, Bouillon B, David A, Haage P, Lichtinger TK. Arthroscopy vs. MRI for a detailed assessment of cartilage disease in osteoarthritis: diagnostic value of MRI in clinical practice. BMC Musculoskelet Disord. 2010 Apr 20;11:75. doi: 10.1186/1471-2474-11-75.
Results Reference
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Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee

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