Evaluation of MRI Diagnosed Meniscal Lesions

Meniscus Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492855
• Other study ID #: ON-02-013-OSi
• Status: Completed
• Phase: N/A
• First received: August 14, 2008
• Last updated: September 12, 2014
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: September 2014
• Source: Northern Orthopaedic Division, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research EthicsDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: December 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Meniscus Lesion

Intervention

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

Behavioral:
• Non-invasive treatment
All patients will receive information and supervised exercises by a physiotherapist.

Locations

Country	Name	City	State
Denmark	Northern Orthopaedic Division, Klinik Aalborg	Aalborg	Northern Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Northern Orthopaedic Division, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigation of improvement in KOOS subscale pain and symptoms	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	Yes