title: Total knee replacement plus physical and medical therapy or treatment with physical and medical therapy alone: a randomised controlled trial in patients with knee osteoarthritis (the MEDIC-study).
abstract: BACKGROUND
  There is a lack of high quality evidence concerning the efficacy of total knee arthroplasty (TKA). According to international evidence-based guidelines, treatment of knee osteoarthritis (KOA) should include patient education, exercise and weight loss. Insoles and pharmacological treatment can be included as supplementary treatments. If the combination of these non-surgical treatment modalities is ineffective, TKA may be indicated. The purpose of this randomised controlled trial is to examine whether TKA provides further improvement in pain, function and quality of life in addition to optimised non-surgical treatment in patients with KOA defined as definite radiographic OA and up to moderate pain.
  
  
  METHODS
  The study will be conducted in The North Denmark Region. 100 participants with radiographic KOA (K-L grade ≥2) and mean pain during the previous week of ≤ 60 mm (0-100, best to worst scale) who are considered eligible for TKA by an orthopaedic surgeon will be included. The treatment will consist of 12 weeks of optimised non-surgical treatment consisting of patient education, exercise, diet, insoles, analgesics and/or NSAIDs. Patients will be randomised to either receiving or not receiving a TKA in addition to the optimised non-surgical treatment. The primary outcome will be the change from baseline to 12 months on the Knee Injury and Osteoarthritis Outcome Score (KOOS)(4) defined as the average score for the subscale scores for pain, symptoms, activities of daily living, and quality of life. Secondary outcomes include the five individual KOOS subscale scores, EQ-5D, pain on a 100 mm Visual Analogue Scale, self-efficacy, pain pressure thresholds, and isometric knee flexion and knee extension strength.
  
  
  CONCLUSIONS
  This is the first randomised controlled trial to investigate the efficacy of TKA as an adjunct treatment to optimised non-surgical treatment in patients with KOA. The results will significantly contribute to evidence-based recommendations for the treatment of patients with KOA.
  
  
  BACKGROUND
  Clinicaltrials.gov reference: NCT01410409.
authors.affiliation: Orthopaedic Surgery Research Unit, Aalborg Hospital, Aarhus University Hospital, Aalborg, Denmark. sots@rn.dk
authors.forename: Soren T
authors.initials: ST
authors.lastname: Skou
authors.forename: Ewa M
authors.initials: EM
authors.lastname: Roos
authors.forename: Mogens B
authors.initials: MB
authors.lastname: Laursen
authors.forename: Michael S
authors.initials: MS
authors.lastname: Rathleff
authors.forename: Lars
authors.initials: L
authors.lastname: Arendt-Nielsen
authors.forename: Ole H
authors.initials: OH
authors.lastname: Simonsen
authors.forename: Sten
authors.initials: S
authors.lastname: Rasmussen
mesh_terms: D000203:Activities of Daily Living; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019645:Arthroplasty, Replacement, Knee; D003131:Combined Modality Therapy; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000000981:diagnostic imaging / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D010146:Pain; D017288:Pain Threshold; D010353:Patient Education as Topic / Q000379:methods*; D026741:Physical Therapy Modalities; D011788:Quality of Life; D011859:Radiography; D016059:Range of Motion, Articular; D020127:Recovery of Function; D016896:Treatment Outcome; D015431:Weight Loss; D055815:Young Adult