Evaluation of MRI Diagnosed Meniscal Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01492855
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : September 15, 2014
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark

Brief Summary:

The knee menisci are two semicircular fibrocartilaginous structures located between the articular cartilage surfaces of the femur and tibia in the medial and lateral joint compartments. The main functions of the menisci are shock absorption and load transmission in the knee, mainly through distribution of mechanical stress over a large area of the joint cartilage.

The hypothesis is that primarily older age, meniscal lesion and high pain score at baseline are associated with poorer outcome.

Condition or disease Intervention/treatment Phase
Meniscus Lesion Procedure: Arthroscopy Behavioral: Non-invasive treatment Not Applicable

Detailed Description:
Meniscal lesions are the most common source of disability of the knee with a reported incidence rate of up to 18 meniscal lesions per 10.000 subjects per year in Denmark. The meniscus may tear as a result of knee trauma or it may tear spontaneously due to aging and degenerative processes. Magnetic resonance imaging (MRI) is increasingly used in the diagnosis of meniscal lesions with documented high sensitivity and specificity. Meniscal lesion symptoms vary from reduction in knee function with decreased muscle strength and difficulties in performing strenuous activities involving knee flexion and rotation to pain, effusion locking and, giving way.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Health Services Research
Official Title: The Value of MRI in the Evaluation of Knees Suspected for Meniscal Lesions
Study Start Date : January 2008
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: Operative treatment Procedure: Arthroscopy
Arthroscopy is offered for the patients who do not benefit from conservative treatment.
Other Name: No other names.
Experimental: Conservative treatment Behavioral: Non-invasive treatment
All patients will receive information and supervised exercises by a physiotherapist.
Other Name: No other names.

Primary Outcome Measures :
  1. Investigation of improvement in KOOS subscale pain and symptoms [ Time Frame: 12 months ]
    A multiple linear regression model is constructed to investigate which pre-treatment prognostic factors are associated to improvement in KOOS subscale pain and symptoms from baseline to follow-up.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical suspicion of meniscal lesion according to pain on weight-bearing activities, locking, normal stability, tenderness at medial and/or lateral joint line, normal X-ray
  • Age > 18 years
  • Able to understand Danish
  • Able to sign an informed consent

Exclusion Criteria:

  • Age < 18 years
  • Unable to understand Danish
  • Unable to sign an informed consent
  • Unstable knee
  • X-ray or MRI that shows other diagnoses

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01492855

Northern Orthopaedic Division, Klinik Aalborg
Aalborg, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Principal Investigator: Ole Simonsen, MD Northern Orthopaedic Division

Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT01492855     History of Changes
Other Study ID Numbers: ON-02-013-OSi
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by Northern Orthopaedic Division, Denmark:
Meniscal lesions
arthroscopic treatment