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van CCT (UK)

van CCT (UK)

Efficacy of MRI in primary care for patients with knee complaints due to trauma.

- candidate number13726
- NTR NumberNTR3689
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-nov-2012
- Secondary IDs2012-190 METC Erasmus MC Rotterdam
- Public TitleEfficacy of MRI in primary care for patients with knee complaints due to trauma.
- Scientific TitleEfficacy of MRI in primary care for patients with knee complaints due to trauma.
- hypothesisOver a period of 12 months follow-up:
1. What is the cost-effectiveness of MRI referral by the general practitioner compared to usual care in patients with persistent traumatic knee complaints?
2. Is MRI referral by the general practitioner noninferior compared to usual care in patients with persistent traumatic knee complaints regarding self reported knee related daily function?
- Healt Condition(s) or Problem(s) studiedTraumatic knee complaints, MRI, Cost-effectiveness , Efficacy
- Inclusion criteriaPatients will be eligible for inclusion if they:
1. (Re)consulted their general practitioner with knee complaints (pain and/or disability of at least 4 weeks) due to trauma or sudden onset in the preceding six months, and;
2. Are aged 18 to 45 years.
- Exclusion criteriaPatients will be excluded if:
1. There is an indication for direct referral to an orthopaedic surgeon such as suspicion of fracture and/or an acute locked knee;
2. The knee complaints due to trauma are already treated in secondary care;
3. The patient is already known with osteoarthritis in the affected knee, other nontraumatic arthropathy, isolated patello-femoral joint pain or patella luxation;
4. There is a previous MRI examination within the same episode of knee complaints;
5. There is a previous surgical intervention on the same knee, and;
6. There are contra-indications for the use of MRI (claustrophobia, metal implants or a pacemaker).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 19-okt-2012
- planned closingdate1-feb-2017
- Target number of participants360
- InterventionsGroup 1; the MRI group:
Patients will be referred for MRI scan (1.5 T) of the affected knee at a participating MRI center within 4 weeks after referral.

Group 2; the usual care group:
These patients will be managed conform the care recommended by the Dutch clinical guideline ‘traumatic knee complaints’.
- Primary outcome1. Lysholm Scale to measure patients’ knee related self reported daily function. The score consists of 8 different items on a 100-point scale with 25 points each attributed to instability and pain, including an activity-grading scale;
2. PROductivity and DISease Questionnaire (PRODISQ) to measure the productivity costs (due to absence of work and reduced productivity in (un)paid work and the questionnaire for Costs (modified TiC-P) to measure direct medical costs of MRI, medical consumption (e.g. other additional diagnostics, referrals, medication, consults, arthroscopy, surgery, physical therapy, aids);
3. EuroQol 5-D self-reported questionnaire (EQ-5D) to measure patients’ quality of life on five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
- Secondary outcome1. The Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure patients’ knee function;
2. 11-point numeric rating scale to capture the severity of knee pain (0=no pain and 10=unbearable pain);
3. The Global Perceived Effect (GPE) to measure patients’ perceived recovery and satisfaction of the patient.
- TimepointsAll participating patients will fill in the questionnaires at baseline and at 1.5, 3, 6, 9 and 12 months follow-up.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator Erasmus Medical Center, Department of General Practice, Leiden University Medical Center (LUMC), Department Radiology
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale:
General practitioners are regularly consulted by patients with traumatic knee complaints. The Dutch clinical guideline ‘traumatic knee complaints’ for general practitioners at present does not recommend referral to MRI because lack of evidence. Direct referral to MRI might be a valuable tool for general practitioners in making appropriate and informed decisions, depending on whether it improves patient outcomes, reduces costs and affects subsequent diagnosis and management.

What is the cost-effectiveness of referral to MRI by the general practitioner compared to usual care in patients with persistent traumatic knee complaints.

Study design:
A multi-centre, open labeled randomized controlled noninferiority trial in combination with a concurrent observational cohort study.

Study population:
Patients (aged between 18 and 45 years) with traumatic knee complaints will be eligible if they have consulted their general practitioner and and report persistent knee complaints till 6 months.

Participating patients will be randomized into two groups:
1. MRI group; the patients will be referred for MRI of the knee by the general practitioner, or;
2. Usual care group; the patients will receive care conform the Dutch general practitioners’ clinical guideline and will not receive an MRI referral by the general practitioner.

Main study parameters/endpoints:
The primary outcomes are self reported knee related daily function (Lysholm), health care and productivity costs (PRODISQ/TIC-P), and quality of life (EuroQol) over a 12 months follow-up period (measured at 0,1.5, 3, 6, 9, 12 months).
Secondary outcomes are patient related health gain measured with function (KOOS), severity of knee pain (NRS) and perceived recovery and satisfaction with management by patient and general practitioner.
- Main changes (audit trail)2-apr-2017: Inclusion criteria NEW: - pain and/or disability
- RECORD7-nov-2012 - 2-apr-2017

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