Evaluation of MRI Diagnosed Meniscal Lesions
The Value of MRI in the Evaluation of Knees Suspected for Meniscal Lesions
1 other identifier
interventional
324
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2008
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 14, 2008
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedSeptember 15, 2014
September 1, 2014
4.8 years
August 14, 2008
September 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Operative treatment
EXPERIMENTALConservative treatment
EXPERIMENTALInterventions
Arthroscopy is offered for the patients who do not benefit from conservative treatment.
All patients will receive information and supervised exercises by a physiotherapist.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Age \< 18 years
- Unable to understand Danish
- Unable to sign an informed consent
- Unstable knee
- X-ray or MRI that shows other diagnoses
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Northern Orthopaedic Division, Klinik Aalborg
Aalborg, Northern Jutland, Denmark
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ole Simonsen, MD
Northern Orthopaedic Division
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2008
First Posted
December 15, 2011
Study Start
January 1, 2008
Primary Completion
November 1, 2012
Study Completion
December 1, 2012
Last Updated
September 15, 2014
Record last verified: 2014-09