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
Scientific
Medical Research Unit
Thornburrow Drive
Stoke on Trent
ST4 7QB
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MRIA |
| Study objectives | 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(s) | North Staffordshire Local Research Ethics Committee on 04/06/2001 |
| Health condition(s) or problem(s) studied | Mechanical Disorder of the knee requiring Arthroscopy |
| Intervention | MRI Scan of knee and knee arthroscopy |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/06/2001 |
| Completion date | 18/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 384 (192 in each arm) |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2001 |
| Date of final enrolment | 18/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Medical Research Unit
Stoke on Trent
ST4 7QB
United Kingdom
ST4 7QB
United Kingdom
Sponsor information
University Hospital of North Staffordshire (UK)
Hospital/treatment centre
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
