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Evaluation of MRI Diagnosed Meniscal Lesions

This study has been completed.
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark Identifier:
First received: August 14, 2008
Last updated: September 12, 2014
Last verified: September 2014

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 Intervention
Meniscus Lesion Procedure: Arthroscopy Behavioral: Non-invasive treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: The Value of MRI in the Evaluation of Knees Suspected for Meniscal Lesions

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • 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.

Enrollment: 324
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Northern Orthopaedic Division, Denmark Identifier: NCT01492855     History of Changes
Other Study ID Numbers: ON-02-013-OSi
Study First Received: August 14, 2008
Last Updated: September 12, 2014

Keywords provided by Northern Orthopaedic Division, Denmark:
Meniscal lesions
arthroscopic treatment processed this record on July 19, 2017