Condition category
Musculoskeletal Diseases
Date applied
16/11/2006
Date assigned
05/01/2007
Last edited
25/04/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Katie Roebuck

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes