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| [ Print-friendly version ] |
| Randomised controlled trial of open access to Magnetic Resonance Imaging (MRI) versus direct referral to orthopaedic surgeons for General Practitioner (GP) patients with continuing knee problems |
| ISRCTN | ISRCTN76616358 |
| DOI | 10.1186/ISRCTN76616358 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Randomised controlled trial of open access to Magnetic Resonance Imaging (MRI) versus direct referral to orthopaedic surgeons for General Practitioner (GP) patients with continuing knee problems |
| Scientific title | |
| Acronym | DAMASK (Direct Access to Magnetic resonance imaging: Assessment for Suspect Knees) |
| Serial number at source | G0001133 (P/Care init) |
| Study hypothesis |
Each year 15% of all patients consult General Practitioners (GPs) for musculo-skeletal disorders. Examination of the knee is now one of the commonest musculo-skeletal applications of Magnetic Resonance Imaging (MRI). There is evidence that MRI allows accurate assessment of meniscal and ligamentous injuries of the knee. With explicit clinical indications in selected patients it can avoid an expensive invasive arthroscopy, reducing the waiting times for those who do need one. However, whether management using MRI affects patients’ quality of life has not been rigorously evaluated. Hence there is uncertainty about whether recommending open access MRI to avoid hospital referral is appropriate. This reflects wide variation both in GPs’ access to, and use of MRI, and in associated costs. Thus the question whether patients presenting to GPs with continuing knee problems should be referred for an MRI scan or directly to an orthopaedic surgeon is crucial to patient management and outcome, and thus to cost-effectiveness.
Hypothesis: 1. To evaluate: a. whether the early use of MRI through open access affects subsequent diagnosis and management b. whether it improves patient outcomes c. whether it reduces net costs to the NHS, patients and society 2. To explore patient and practitioner preferences for open access to MRI and to investigate the generalisability of results obtained from the three experimental sites in York, Wrexham and Aberdeen By including Cardiff, where direct access to MRI has been available for eight years, we shall study the effect of such access on the case mix of GP referrals for direct MRI and referrals to the orthopaedics department. |
| Lay summary | |
| Ethics approval | The trial protocol was designed to comply with the Declaration of Helsinki as adopted by the World Medical Association. UK Northern and Yorkshire Multi-Centre Research Ethics Committee approved the protocol (reference number MREC/1/3/59). |
| Study design | Multicentre, randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Knee problems |
| Participants - inclusion criteria |
1. People aged between 18 and 55
2. Suspected internal derangement of the knee suggesting meniscal or ligamentous patello-femoral joint-pain 3. Continuing symptoms at least six weeks after the initial consultation during the study period despite conservative treatment (e.g., analgesics, physiotherapy or tubigrip) 4. GP is considering orthopaedic or MRI referral |
| Participants - exclusion criteria |
1. The GP judges that urgent orthopaedic referral is necessary at the initial consultation
2. Suspected osteoarthritis or other non-traumatic arthropathy 3. Isolated patello-femoral joint pain 4. Previous MRI scan within this episode of care 5. Previous surgical intervention (excluding diagnostic arthroscopy) on the same knee 6. Contraindications to the use of MRI, for example pacemaker, intra-cranial aneurysm clips, or orbital metallic foreign body 7. Patients who reside in Orkney or Shetland |
| Anticipated start date | 03/01/2002 |
| Anticipated end date | 31/12/2006 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 500 |
| Interventions |
All general practice staff are invited to a training session about the appropriate use of MRI and interpretation of findings.
Within practices individual participants will be randomised between: 1. The local radiology department for an MRI scan - depending on the result of the scan the GP might then refer the participant to be seen by an orthopaedic surgeon; and 2. The local orthopaedic department for a consultation with the specialist - depending on the result of this visit, the surgeon might then send the participant for an MRI scan. To ensure that the evaluation covers events up to and including arthroscopy we shall follow patients from random allocation for 24 months using questionnaires asking about their general health and experience of knee pain. Economic analyses will compare benefits to participants with costs to both the NHS and participants themselves. |
| Primary outcome measure(s) | The primary outcome measure is the change in the physical functioning sub-scale of the Short Form 36-item questionnaire (SF-36) at six months. A change of 6.75 points on the scale has been agreed as being clinically significant. |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | Medical Research Council (MRC) (UK) (ref: G0001133) |
| Trial website | http://www.york.ac.uk/healthsciences/centres/trials/damask/dam2.htm |
| Publications |
1. 2006 protocol in http://www.ncbi.nlm.nih.gov/pubmed/17040558
2. 2007 results re influence of MRI on GP's decision in http://www.ncbi.nlm.nih.gov/pubmed/17688756 3. 2008 results re effectiveness of GP's access to MRI in http://www.ncbi.nlm.nih.gov/pubmed/19000393 4. 2008 results re cost-effectiveness of MRI in http://www.ncbi.nlm.nih.gov/pubmed/19000394 5. 2010 participant feedback survey results in http://www.ncbi.nlm.nih.gov/pubmed/21122094 |
| Contact name | Dr Ian Russell |
| Address |
Department of Health Sciences and Clinical Evaluation
University of York Alcuin College Heslington |
| City/town | York |
| Zip/Postcode | YO10 5DD |
| Country | United Kingdom |
| Sponsor | University of York (UK) |
| Address | Heslington |
| City/town | York |
| Zip/Postcode | YO10 5DD |
| Country | United Kingdom |
| Sponsor website: | http://www.york.ac.uk/ |
| Date applied | 02/05/2001 |
| Last edited | 01/02/2011 |
| Date ISRCTN assigned | 02/05/2001 |
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| © 2013 ISRCTN unless otherwise stated. | |
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