Evaluation of MRI Diagnosed Meniscal Lesions

Not Applicable

Completed

• Conditions: Meniscus Lesion
• Interventions: Behavioral: Non-invasive treatment; Procedure: Arthroscopy

• Registration Number: NCT01492855
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-08-14
• Study First Submitted QC: 2011-12-13
• Study First Posted: 2011-12-15
• Primary Completion: 2012-11
• Study Completion: 2012-12
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-12
• Last Update Posted: 2014-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 324

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conservative treatment	Non-invasive treatment	-
Operative treatment	Arthroscopy	-

Primary Outcome Measures

Name	Time	Method
Investigation of improvement in KOOS subscale pain and symptoms	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.

Trial Locations

Locations (1)

Northern Orthopaedic Division, Klinik Aalborg; 🇩🇰 Aalborg, Northern Jutland, Denmark