Evaluation of MRI Diagnosed Meniscal Lesions

NCT ID: NCT01492855

Last Updated: 2014-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Meniscus Lesion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Operative treatment

Group Type EXPERIMENTAL

Arthroscopy

Intervention Type PROCEDURE

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

Conservative treatment

Group Type EXPERIMENTAL

Non-invasive treatment

Intervention Type BEHAVIORAL

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

Interventions

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Arthroscopy

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

Intervention Type PROCEDURE

Non-invasive treatment

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

Intervention Type BEHAVIORAL

Other Intervention Names

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No other names. No other names.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northern Orthopaedic Division, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ole Simonsen, MD

Role: PRINCIPAL_INVESTIGATOR

Northern Orthopaedic Division

Locations

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Northern Orthopaedic Division, Klinik Aalborg

Aalborg, Northern Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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ON-02-013-OSi

Identifier Type: -

Identifier Source: org_study_id

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