Evaluation of MRI Diagnosed Meniscal Lesions

September 12, 2014 updated by: Northern Orthopaedic Division, Denmark

The Value of MRI in the Evaluation of Knees Suspected for Meniscal Lesions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Northern Jutland
      • Aalborg, Northern Jutland, Denmark
        • Northern Orthopaedic Division, Klinik Aalborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern Orthopaedic Division, Denmark

Investigators

  • Principal Investigator: Ole Simonsen, MD, Northern Orthopaedic Division

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 14, 2008

First Submitted That Met QC Criteria

December 13, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

September 15, 2014

Last Update Submitted That Met QC Criteria

September 12, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ON-02-013-OSi

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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