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 |
| Protocol serial number | N/A |
| Sponsor | University Hospital of North Staffordshire (UK) |
| Funder | University Hospital of North Staffordshire (UK) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Medical Research Unit
Thornburrow Drive
Stoke on Trent
ST4 7QB
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Comparison of the proportion of arthroscopies (diagnostic or therapeutic) carried out in each arm of the study |
| Key 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. |
| Completion date | 18/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 384 |
| 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
- United Kingdom
- England
Study participating centre
ST4 7QB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
