|- candidate number||13726|
|- NTR Number||NTR3689|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-nov-2012|
|- Secondary IDs||2012-190 METC Erasmus MC Rotterdam|
|- Public Title||Efficacy of MRI in primary care for patients
with knee complaints due to trauma.|
|- Scientific Title||Efficacy of MRI in primary care for patients
with knee complaints due to trauma.|
|- ACRONYM||TACKLE trial|
|- hypothesis||Over 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) studied||Traumatic knee complaints, MRI, Cost-effectiveness , Efficacy|
|- Inclusion criteria||Patients 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 criteria||Patients 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
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||19-okt-2012|
|- planned closingdate||1-feb-2017|
|- Target number of participants||360|
|- Interventions||Group 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 outcome||1. 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
|- Secondary outcome||1. The Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure patients’
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.
|- Timepoints||All participating patients will fill in the questionnaires at baseline and at 1.5, 3, 6, 9 and 12 months follow-up.|
|- Trial web site||http://www.tackletrial.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. P.A.J. Luijsterburg|
|- CONTACT for SCIENTIFIC QUERIES||Dr. P.A.J. Luijsterburg|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of General Practice, Leiden University Medical Center (LUMC), Department Radiology|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
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.
A multi-centre, open labeled randomized controlled noninferiority trial in
combination with a concurrent observational cohort study.
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|
|- RECORD||7-nov-2012 - 2-apr-2017|