NCT01695720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 28, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

11 months

First QC Date

September 13, 2012

Last Update Submit

May 29, 2013

Conditions

Meniscus TearsLoose BodiesArticular OsteoarthritisArticular or Capsular Trauma

Keywords

Knee InjuriesMeniscus InjuriesArticular Cartilage InjuriesOrthopaedic DiagnosticMagnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Study Arms (1)

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.

Procedure: VisionScope Imaging (VSI) Exam

Interventions

VisionScope Imaging (VSI) ExamPROCEDURE

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.

VisionScope Imaging (VSI) Exam

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected meniscal injuries to the knee
  • Suspected articular cartilage injuries to the knee

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Kerlan-Jobe Orthopaedic Foundation

Los Angeles, California, 90045, United States

Location

Stanford School of Medicine

Redwood City, California, 94063, United States

Location

Santa Monica Orthopaedic & Sports Medicine Group (SMOG)

Santa Monica, California, 90404, United States

Location

Andrews Research and Education Institute

Gulf Breeze, Florida, 32561, United States

Location

Emory University Hospital

Atlanta, Georgia, 30329, United States

Location

University of Texas SouthWestern

Dallas, Texas, 75390, United States

Location

Mansfield Orthopaedics (Copley Hospital)

Morrisville, Vermont, 05661, United States

Location

Related Publications (10)

  • Rheumatology 2000; 39: 700-706, British Society for Rheumatology

    BACKGROUND

  • 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.

    PMID: 17279041BACKGROUND

  • 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.

    PMID: 7489301BACKGROUND

  • 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.

    PMID: 9246993BACKGROUND

  • 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.

    PMID: 8804283BACKGROUND

  • 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.

    PMID: 18094289BACKGROUND

  • 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.

    PMID: 19050885BACKGROUND

  • 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.

    PMID: 3535549BACKGROUND

  • 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.

    PMID: 18297284BACKGROUND

  • 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.

    PMID: 20406481BACKGROUND

MeSH Terms

Conditions

Knee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Thomas J Gill, IV, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2012

First Posted

September 28, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

US(7)