Objective To determine whether referral to MRI by the general practitioner (GP) is non-inferior to usual care (no access to MRI by GPs) in patients with traumatic knee complaints regarding knee-related daily function.
Methods This was a multicentre, non-inferiority randomised controlled trial with 1-year follow-up. GPs invited eligible patients during or after their consultation. Eligible patients (18–45 years) consulted a GP with knee complaints due to a trauma during the previous 6 months. Patients allocated to the MRI group received an MRI at (median) 7 (IQR 1–33) days after the baseline questionnaire. Patients in the usual care group received information on the course of knee complaints, and a referral to a physiotherapist or orthopaedic surgeon when indicated. The primary outcome measure was knee-related daily function measured with the Lysholm scale (0 to 100; 100=excellent function) over 1 year, with a non-inferiority margin of 6 points.
Results A total of 356 patients were included and randomised to MRI (n=179) or usual care (n=177) from November 2012 to December 2015. MRI was non-inferior to usual care concerning knee-related daily function during 1-year follow-up, for the intention-to-treat (overall adjusted estimate: 0.33; 95% CI −1.73 to 2.39) and per-protocol (overall adjusted estimate: 0.06; 95% CI −2.08 to 2.19) analysis. There were no differences between both groups in the amount of patients visiting other healthcare providers.
Conclusion MRI in general practice in patients with traumatic knee complaints was non-inferior to usual care regarding knee-related daily function during 1-year follow-up.
Trial registration number NTR3689.
- knee injuries
- general practice
- primary care
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Contributors NMS: data collection, analysis, data interpretation and manuscript writing. KvO: data collection, extensive editorial review of manuscript writing. PAJL: conception, design, analysis, data interpretation and extensive editorial review of manuscript writing. SMAB-Z: conception, design, data interpretation and extensive editorial review of manuscript writing. MR: conception, design, data interpretation and editorial review of manuscript. JLB: conception, design, data interpretation and editorial review of manuscript. WBvdH: design, data interpretation and editorial review of manuscript. PRA: design data interpretation and editorial review of manuscript. PJEB: design, data interpretation and editorial review of manuscript. BK: design, data interpretation and editorial review of manuscript. RGHHN: design, data interpretation and editorial review of manuscript. JANV: design, data interpretation and editorial review of manuscript. All authors approved the final version. Upon request, all authors had full access to the data in this study and can therefore take responsibility for the integrity of the data and the accuracy of the data analysis. The guarantors of this study are PAJL and MR and affirm that this manuscript is an honest, accurate and transparent account of the study being reported. No important aspects of this study were omitted and all discrepancies from the published study protocol were explained.
Funding This trial was financially supported by ZonMW, the Netherlands Organisation for Health Research and Development, project number 171202005.
Disclaimer The sponsor was not involved in the data collection, nor in the analyses or in the interpretation of the data. Furthermore, no approval was needed from the sponsor to publish this study and all authors were independent from the sponsor.
Competing interests The authors had financial support from ZonMW (the Netherlands Organisation for Health Research and Development) for the submitted work.
Patient consent Obtained.
Ethics approval The study was approved by the Medical Ethics Committee of the Erasmus Medical Centre and by the Dutch National Central Committee on Research Involving Human Subjects (CCMO) with file number NL40296.078.12. This trial is also registered in the Dutch Trial Registration with trial ID: NTR3689.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement On our informed consent form, we added a separate question in which we specifically asked the patient if he/she approves or disapproves the use of their anonymised data in the coming 15 years for other studies on traumatic knee complaints with the same research goals as ours. Most patients approved this use whereas some patients did not. We would be pleased to share the data of the approving patients with the restriction that it has the same research goals as ours (please provide a full project description) and only in the coming 15 years. Furthermore, the researchers involved in this study should have sufficient time to publish their own planned articles, within 1 year after this publication. Please contact the corresponding author via the provided contact data for requests upon data sharing.