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| The impact of magnetic resonance imaging on the rate of arthroscopy and patient outcome for knee disorders requiring arthroscopy |
| Source of record | UK Trials |
| ISRCTN | ISRCTN07964137 |
| Date ISRCTN assigned | 05/01/2007 |
| Local reference number(s) | N/A |
| Public title | The impact of magnetic resonance imaging on the rate of arthroscopy and patient outcome for knee disorders requiring arthroscopy |
| Scientific title | |
| Acronym | MRIA |
| Disease/condition/study domain | Mechanical Disorder of the knee requiring Arthroscopy |
| 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. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | North Staffordshire Local Research Ethics Committee gave a favourable opinion 4th June 2001. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - 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 |
| Patient information material | |
| Anticipated start date | 01/06/2001 |
| Anticipated end date | 18/08/2006 |
| Status of trial | Completed |
| Target number of participants | 384 (192 in each arm) |
| Interventions | MRI Scan of knee and knee arthroscopy |
| Primary outcome measure(s) | Comparison of the proportion of arthroscopies (diagnostic or therapeutic) carried out in each arm of the study |
| Secondary outcome measure(s) | 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 |
| Sources of funding | University Hospital of North Staffordshire (UK) |
| Sponsor name | University Hospital of North Staffordshire (UK) |
| Sponsor details | Trust Headquarters Royal Infirmary Princes Road Stoke on Trent United Kingdom ST4 7LN |
| Sponsor website | http://www.nsht.nhs.uk/ |
| Contact name | Miss Katie Roebuck |
| Contact details | Medical Research Unit Thornburrow Drive Stoke on Trent United Kingdom ST4 7QB |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN07964137 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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