Traumatic knee complaints, MRI, Primary care, Cost-effectiveness, Efficacy, Randomized controlled trial, Noninferiority design
Conditions
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’.
Sponsors
Erasmus MC, Erasmus University Medical Center, Department General practice (PO Box 2040, 3000 CA Rotterdam, Netherlands).
- Leiden University Medical Center (LUMC), Department Radiology (PO Box 9600, 2300 RC Leiden, Netherlands).
Eligibility
Inclusion criteria
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. 3. Pain and/or disability
Exclusion criteria
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 a pacemaker).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 anxiety/depression. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. 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. | — |
Contacts
Public ContactMonique Reijnierse
Leiden University Medical Center, Department of Radiology, C-2-S, 2300RC Leiden, The Netherlands
Outcome results
None listed