Evaluation of MRI Diagnosed Meniscal Lesions

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier:
NCT01492855
First received: August 14, 2008
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Meniscus Lesion
Procedure: Arthroscopy
Behavioral: Non-invasive treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Health Services Research
Official Title: The Value of MRI in the Evaluation of Knees Suspected for Meniscal Lesions

Further study details as provided by Northern Orthopaedic Division, Denmark:

Primary Outcome Measures:
  • Investigation of improvement in KOOS subscale pain and symptoms [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 324
Study Start Date: January 2008
Study Completion Date: December 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Operative treatment Procedure: Arthroscopy
Arthroscopy is offered for the patients who do not benefit from conservative treatment.
Other Name: No other names.
Experimental: Conservative treatment Behavioral: Non-invasive treatment
All patients will receive information and supervised exercises by a physiotherapist.
Other Name: No other names.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492855

Locations
Denmark
Northern Orthopaedic Division, Klinik Aalborg
Aalborg, Northern Jutland, Denmark
Sponsors and Collaborators
Northern Orthopaedic Division, Denmark
Investigators
Principal Investigator: Ole Simonsen, MD Northern Orthopaedic Division
  More Information

No publications provided

Responsible Party: Northern Orthopaedic Division, Denmark
ClinicalTrials.gov Identifier: NCT01492855     History of Changes
Other Study ID Numbers: ON-02-013-OSi
Study First Received: August 14, 2008
Last Updated: March 28, 2014
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Northern Orthopaedic Division, Denmark:
Meniscal lesions
MRI
arthroscopic treatment

ClinicalTrials.gov processed this record on July 26, 2014