Efficacy of MRI in primary care for patientswith knee complaints due to trauma.
- Conditions
- Traumatic knee complaints, MRI, Primary care, Cost-effectiveness, Efficacy, Randomized controlled trial, Noninferiority design
- Registration Number
- NL-OMON25720
- Lead Sponsor
- 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).
- Brief Summary
1. Swart NM, van Oudenaarde K, Algra PR, Bindels PJ, van den Hout WB, Koes BW, Nelissen RGHH, Verhaar JAN, Bloem JL, Bierma-Zeinstra SMA, Reijnierse M, Luijsterburg PAJ. Efficacy of MRI in primary care for patients with knee complaints due to trauma: protocol of a randomized controlled non-inferiority trial (TACKLE trial). BMC Musculoskeletal Disordering. 2014; mar 3; 15:63. 2. van Oudenaarde K, Swart NM, Bierma-Zeinstra MSA, Algra PR, Bindels PJ, Nelissen RGHH, Verhaar JAN, Luijsterburg PAJ, Reijnierse M, van den Hout WB. General practitioners referring adults to MR imaging for knee pain: a randomized controlled trial to assess cost-effectiveness. Radiology 2018 Jul;288(1):170-176. 3. Van Oudenaarde K, Swart NM, Bloem JL, Bierma-Zeinstra SMA, Algra PR, Bindels PJE, et al. MRI-knie bij iedere patiënt met acuut knietrauma niet kosteneffectief. Huisarts Wet 2018;61:DOI: 10.1007/s12445-018-0267-0. Dit is een bewerkte vertaling met toestemming van Radiology 2018 Jul;288(1):170-176 https://www.henw.org/artikelen/mri-knie-bij-iedere-patient-met-acuut-knietrauma-niet-kosteneffectief Dissertation Kim van Oudenaarde, Leiden University November 22, 2018 https://openaccess.leidenuniv.nl/bitstream/handle/1887/67119/front.pdf?sequence=3 Dissertation Nynke Swart, Erasmus Medical Center October 15, 2019 https://epubs.ogc.nl/?epub=n.swart
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 360
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;
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Lysholm Scale to measure patients’ knee related self reported daily function. The<br>score consists of 8 different items on a 100-point scale with 25 points each attributed<br>to instability and pain, including an activity-grading scale;<br /><br>2. PROductivity and DISease Questionnaire (PRODISQ) to measure the productivity<br>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);<br /><br>3. EuroQol 5-D self-reported questionnaire (EQ-5D) to measure patients’ quality of life<br>on five dimensions; mobility, self-care, usual activities, pain/discomfort, and<br>anxiety/depression.
- Secondary Outcome Measures
Name Time Method 1. The Knee Injury and Osteoarthritis Outcome Score (KOOS) to measure patients’<br>knee function;<br /><br>2. 11-point numeric rating scale to capture the severity of knee pain (0=no pain and 10=unbearable pain);<br /><br>3. The Global Perceived Effect (GPE) to measure patients’ perceived recovery and<br>satisfaction of the patient.