• Victor A van de Graaf, Vanessa A B Scholtes, Nienke Wolterbeek, Noorduyn Julia C A JC Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands., Camille Neeter, Maurits W van Tulder, Daniël B F Saris, Arthur de Gast, Rudolf W Poolman, and Escape Research Group.
• Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.
• BMJ Open. 2016 Dec 21; 6 (12): e014381.

IntroductionRecent studies show similar outcome between surgery and conservative treatment in patients with non-obstructive meniscal tears. However, surgery is still often preferred over conservative treatment. When conservative treatment is non-inferior to surgery, shifting the current standard treatment choice to conservative treatment alone could save over €30 millions of direct medical costs on an annual basis. Economic evaluation studies comparing surgery to conservative treatment are lacking.Methods And AnalysisA multicentre randomised controlled trial (RCT) with an economic evaluation alongside was performed to assess the (cost)-effectiveness of surgery and conservative treatment for meniscal tears. We will include 402 participants between 45 and 70 years with an MRI-confirmed symptomatic, non-obstructive meniscal tears to prove non-inferiority of conservative treatment. Block randomisation will be web-based. The primary outcome measure is a physical function, measured by the International Knee Documentation Committee 'Subjective Knee Form'. Furthermore, we will perform a cost-effectiveness and cost-utility analysis from societal perspective and a budget impact analysis from a societal, government and insurer perspective. Secondary outcomes include general health, quality of life, activity level, knee pain, physical examination, progression of osteoarthritis and the occurrence of adverse events.Ethics And DisseminationThis RCT will be performed in accordance with the Declaration of Helsinki and has been approved by the Ethics Committee (number NL44188.100.13). The results of this study will be reported in peer-reviewed journals and at international conferences. We further aim to disseminate our results to guideline committees.Trial Registration NumberNCT01850719.Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

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