Meniscus TearsVSI-001NCT01695720
Clinical Efficacy Study Comparing VisionScope Imaging (VSI) to Magnetic Resonance Imaging (MRI) in Injuries of the Knee
A study testing VisionScope Imaging (VSI) Exam in people with Meniscus Tears and Loose Bodies, run by VisionScope Technologies at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Meniscus Tears, Loose Bodies, Articular Osteoarthritis
- What is being tested?
- VisionScope Imaging (VSI) Exam
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 7 sitesUnited States
- Study dates
- Jun 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected meniscal injuries to the knee
- Suspected articular cartilage injuries to the knee
Who cannot join
- 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 locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory University Hospital
Atlanta, Georgia, 30329
University of Texas SouthWestern
Dallas, Texas, 75390
Andrews Research and Education Institute
Gulf Breeze, Florida, 32561
Kerlan-Jobe Orthopaedic Foundation
Los Angeles, California, 90045
Mansfield Orthopaedics (Copley Hospital)
Morrisville, Vermont, 05661
Stanford School of Medicine
Redwood City, California, 94063
Santa Monica Orthopaedic & Sports Medicine Group (SMOG)
Santa Monica, California, 90404
About this study
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
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.
Read the 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.
- Being tested
- VisionScope Imaging (VSI) Exam
- Keywords
- Knee Injuries, Meniscus Injuries, Articular Cartilage Injuries, Orthopaedic Diagnostic, Magnetic Resonance Imaging
- Medical subject headings
- Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisionScope Imaging (VSI) ExamProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| VisionScope Imaging (VSI) Exam | Experimental | 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. Receives: Procedure: VisionScope Imaging (VSI) Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Meniscus TearsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- VisionScope Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas J Gill, IV, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01695720
- Sponsor's protocol ID
- VisionScope VSI-001
- Acronym
- VSI-001
- Status last verified
- May 2013
- First submitted
- 13 Sep 2012
- Last updated
- 31 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rheumatology 2000; 39: 700-706, British Society for Rheumatology
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.
PubMed 17279041Ruwe PA, McCarthy SM. Cost effectiveness of magnetic resonance imaging of the knee. Magn Reson Imaging Clin N Am. 1994 Aug;2(3):475-9.
PubMed 7489301Rappeport 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.
PubMed 9246993Rangger 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.
PubMed 8804283De 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.
PubMed 18094289Halinen 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.
PubMed 19050885Mandelbaum 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.
PubMed 3535549Rayan 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.
PubMed 18297284von 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.
PubMed 20406481
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01695720
- Acronym / sponsor ID
- VSI-001 / VisionScope VSI-001
- Keywords
- Knee Injuries, Meniscus Injuries, Articular Cartilage Injuries, Orthopaedic Diagnostic, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- VisionScope TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VisionScope Imaging (VSI) Exam | Experimental | Procedure: VisionScope Imaging (VSI) ExamA 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Suspected meniscal injuries to the knee
- Suspected articular cartilage injuries to the knee
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VisionScope Imaging (VSI) ExamThe 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. | Procedure or surgery | VisionScope Imaging (VSI) Exam |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2013.
- BackgroundRheumatology 2000; 39: 700-706, British Society for Rheumatology
- Background: PubMed 17279041Ryzewicz 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.
- Background: PubMed 7489301Ruwe PA, McCarthy SM. Cost effectiveness of magnetic resonance imaging of the knee. Magn Reson Imaging Clin N Am. 1994 Aug;2(3):475-9.
- Background: PubMed 9246993Rappeport 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.
- Background: PubMed 8804283Rangger 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.
- Background: PubMed 18094289De 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.
- Background: PubMed 19050885Halinen 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.
- Background: PubMed 3535549Mandelbaum 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.
- Background: PubMed 18297284Rayan 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.
- Background: PubMed 20406481von 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Gill, IV, MD principal investigator
Massachusetts General Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VisionScope Imaging (VSI) Exam in people with Meniscus Tears and Loose Bodies, run by VisionScope Technologies at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01695720, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2013.