title: Cost-effectiveness of Early Surgery versus Conservative Treatment with Optional Delayed Meniscectomy for Patients over 45 years with non-obstructive meniscal tears (ESCAPE study): protocol of a randomised controlled trial.
abstract: Recent 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.
  
  
  
  A 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.
  
  
  
  This 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.
  
  
  
  NCT01850719.
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.
authors.forename: Victor A
authors.initials: VA
authors.lastname: van de Graaf
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.
authors.forename: Vanessa A B
authors.initials: VA
authors.lastname: Scholtes
authors.affiliation: Department of Orthopaedic Surgery, St. Antonius Ziekenhuis, Nieuwegein, The Netherlands.
authors.forename: Nienke
authors.initials: N
authors.lastname: Wolterbeek
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.
authors.forename: Julia C A
authors.initials: JC
authors.lastname: Noorduyn
authors.affiliation: Neeter Fysiotherapie, Amsterdam, The Netherlands.
authors.forename: Camille
authors.initials: C
authors.lastname: Neeter
authors.affiliation: Department of Health Sciences & EMGO+ Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
authors.forename: Maurits W
authors.initials: MW
authors.lastname: van Tulder
authors.affiliation: Department of Orthopaedic Surgery, UMC Utrecht, Utrecht, The Netherlands.
authors.forename: Daniël B F
authors.initials: DB
authors.lastname: Saris
authors.affiliation: Department of Orthopaedic Surgery, Diakonessenhuis, Utrecht, The Netherlands.
authors.forename: Arthur
authors.initials: A
authors.lastname: de Gast
authors.affiliation: Department of Orthopaedic Surgery, Joint Research, OLVG, Amsterdam, The Netherlands.
authors.forename: Rudolf W
authors.initials: RW
authors.lastname: Poolman
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D000072700:Conservative Treatment; D017046:Cost Savings; D003362:Cost-Benefit Analysis; D005260:Female; D050724:Fractures, Cartilage / Q000191:economics / Q000534:rehabilitation / Q000601:surgery / Q000628:therapy*; D017048:Health Care Costs; D006801:Humans; D007718:Knee Injuries / Q000191:economics / Q000534:rehabilitation / Q000601:surgery / Q000628:therapy*; D008297:Male; D000074403:Meniscectomy; D008592:Menisci, Tibial / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D020127:Recovery of Function; D012107:Research Design; D000070600:Tibial Meniscus Injuries / Q000191:economics / Q000534:rehabilitation / Q000601:surgery / Q000628:therapy*
keywords: Economic evaluation; Randomized controlled trial; meniscectomy; meniscus; physical therapy