Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
MRIA
Study hypothesis
To determine the usefulness, effectiveness and efficieny of Magnetic Resonance Imaging (MRI) compared with diagnostic arthroscopy in the management of mechanical knee problems at six weeks and six months to follow up. The specific objectives are:
1. To measure the likely reduction in arthroscopies of using MRI and selected diagnostic arthroscopies compared with diagnostic arthroscopy alone.
2. Determine patient-based clinical economic outcomes of care when using MRI and selected diagnostic arthroscopy compared with arthroscopy alone in the management.
Ethics approval
North Staffordshire Local Research Ethics Committee on 04/06/2001
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mechanical Disorder of the knee requiring Arthroscopy
Intervention
MRI Scan of knee and knee arthroscopy
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Comparison of the proportion of arthroscopies (diagnostic or therapeutic) carried out in each arm of the study
Secondary outcome measures
1. A simple generic measure of health outcome. It allows an accurate self-description of current health related quality of life, assessing mobility, self-care, usual activity level, pain/discomfort and anxiety/depression.
2. Short Form health survey (SF36): a comprehensive generic measure of health outcome.
3. Knee injury and OsteoArthritis (OA) score: a self reported measure of symptoms, stiffness, pain, function and quality of life specific to knee injury.
4. Knee Society Score: will be carried out by a trained independent assessor (physiotherapist) who will be blinded to the management policy used.
5. Pain Severity
6. Patient satisfaction
Overall trial start date
01/06/2001
Overall trial end date
18/08/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients currently listed for arthroscopy or who have been admitted to hospital with an acute knee injury
2. Aged 18 years and above
3. Mechanical knee problem in whom an arthroscopy is indicated. Defined pragmatically as: suspected internal derangement of the knee e.g., cruciate/collateral ligament haemarthrosis (occurring in first 12 hours of injury) in the absence of fracture
4. Convincing symptoms but no signs, such as history of locking or giving way but normal exam
5. Unresolved significant symtoms after conservative treatment
6. Unresolved knee pain
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
384 (192 in each arm)
Participant exclusion criteria
1. Multiple trauma
2. Unable or unwilling to give informed consent
3. Tumour
4. Suspected primary synovial disease
5. Previous arthroscopy of knee
6. Contraindications to MRI: e.g., pacemaker, pregnancy, ferric implants
7. Knee infection
8. Previous MRI of the affected knee
Recruitment start date
01/06/2001
Recruitment end date
18/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Medical Research Unit
Stoke on Trent
ST4 7QB
United Kingdom
Sponsor information
Organisation
University Hospital of North Staffordshire (UK)
Sponsor details
Trust Headquarters
Royal Infirmary
Princes Road
Stoke on Trent
ST4 7LN
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital of North Staffordshire (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary