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OpenTrials
Completed

NCT Number: NCT01492855

Evaluation of MRI Diagnosed 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.

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Key information

Conditions

Meniscus Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northern Orthopaedic Division, Klinik Aalborg

Aalborg, Northern Jutland, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthroscopy

Procedure

Arthroscopy is offered for the patients who do not benefit from conservative treatment.

Other names: No other names.

Non-invasive treatment

Behavioral

All patients will receive information and supervised exercises by a physiotherapist.

Other names: No other names.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Northern Orthopaedic Division, Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 15, 2011
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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