The impact of magnetic resonance imaging on the rate of arthroscopy and patient outcome for knee disorders requiring arthroscopy

ISRCTN ISRCTN07964137
DOI https://doi.org/10.1186/ISRCTN07964137
Secondary identifying numbers N/A
Submission date
16/11/2006
Registration date
05/01/2007
Last edited
25/04/2014
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Katie Roebuck
Scientific

Medical Research Unit
Thornburrow Drive
Stoke on Trent
ST4 7QB
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study acronymMRIA
Study objectivesTo 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(s)North Staffordshire Local Research Ethics Committee on 04/06/2001
Health condition(s) or problem(s) studiedMechanical Disorder of the knee requiring Arthroscopy
InterventionMRI Scan of knee and knee arthroscopy
Intervention typeOther
Primary outcome measureComparison of the proportion of arthroscopies (diagnostic or therapeutic) carried out in each arm of the study
Secondary outcome measures1. 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 study start date01/06/2001
Completion date18/08/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants384 (192 in each arm)
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/06/2001
Date of final enrolment18/08/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Medical Research Unit
Stoke on Trent
ST4 7QB
United Kingdom

Sponsor information

University Hospital of North Staffordshire (UK)
Hospital/treatment centre

Trust Headquarters
Royal Infirmary
Princes Road
Stoke on Trent
ST4 7LN
England
United Kingdom

Website http://www.nsht.nhs.uk/

Funders

Funder type

Hospital/treatment centre

University Hospital of North Staffordshire (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan