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	https://doi.org/10.1186/ISRCTN76616358
Secondary identifying numbers	G0001133 (P/Care init)

Submission date: 02/05/2001
Registration date: 02/05/2001
Last edited: 01/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Ian Russell
Scientific

Department of Health Sciences and Clinical Evaluation
University of York
Alcuin College
Heslington
York
YO10 5DD
United Kingdom

Study information

Study design	Multicentre, randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Scientific title
Study acronym	DAMASK (Direct Access to Magnetic resonance imaging: Assessment for Suspect Knees)
Study objectives	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.
Ethics approval(s)	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).
Health condition(s) or problem(s) studied	Knee problems
Intervention	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.
Intervention type	Other
Primary outcome measure	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 measures	No secondary outcome measures
Overall study start date	03/01/2002
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	500
Key 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
Key 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
Date of first enrolment	03/01/2002
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Health Sciences and Clinical Evaluation

York
YO10 5DD
United Kingdom

Sponsor information

University of York (UK)
University/education

Heslington
York
YO10 5DD
England
United Kingdom

Website	http://www.york.ac.uk/
"ROR"	https://ror.org/04m01e293

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0001133)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

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

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	13/10/2006	Yes	No
Results article	results re influence of MRI on GP's decision	01/08/2007	Yes	No
Results article	results re cost-effectiveness of MRI	01/11/2008	Yes	No
Results article	results re effectiveness of GP's access to MRI	01/11/2008	Yes	No
Results article	participant feedback survey results	01/12/2010	Yes	No