title: Risk factors predictive of joint replacement in a 2-year multicentre clinical trial in knee osteoarthritis using MRI: results from over 6 years of observation.
abstract: OBJECTIVE
  To identify predictive factors for total knee replacement (TKR) using data from MRI of knee osteoarthritis patients in a phase III multicentre disease-modifying osteoarthritis drug (DMOAD) study.
  
  
  METHODS
  Knee osteoarthritis patients from a 2-year clinical trial evaluating licofelone versus naproxen were investigated for the incidence of TKR of the study knee. Patients (n=161) who completed the study according to protocol were selected. Incidence of TKR was assessed blindly to the treatment following telephone interviews (n=123).
  
  
  RESULTS
  18 TKR (14.6%) were performed in 4-7 years following enrolment in the original study. More TKR were performed within the naproxen than the licofelone group (61% vs 39%, p=0.232). Baseline score of bone marrow lesions (BML) in the medial compartment (p=0.0001), medial joint space width (JSW) as assessed by standardised radiographs (p=0.0008), presence of severe medial meniscal tear (p=0.004), medial meniscal extrusion (p=0.013), and C-reactive protein level (p=0.049) were strong predictors of TKR. Changes at the end of the study also yielded strong predictors: change in cartilage volume of the medial compartment (p=0.005) and of the global knee (p=0.034), reduction in the JSW of greater than 7% (p=0.009), and WOMAC pain (p=0.009) and function (p=0.023) scores. Multivariate analysis showed that baseline severe medial meniscal tear (p=0.023) and presence of medial BML (p=0.025) were the strongest independent long-term predictors of TKR.
  
  
  CONCLUSIONS
  This study shows that in the context of osteoarthritis trials, clinical data and structural changes identified by MRI allow prediction of a 'hard' outcome such as TKR. The findings support the usefulness and predictive value of MRI in defining study outcome in DMOAD trials.
authors.affiliation: Osteoarthritis Research Unit, University of Montreal Hospital Research Centre, Notre-Dame Hospital, Montreal, Quebec, Canada.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Raynauld
authors.forename: Johanne
authors.initials: J
authors.lastname: Martel-Pelletier
authors.forename: Boulos
authors.initials: B
authors.lastname: Haraoui
authors.forename: Denis
authors.initials: D
authors.lastname: Choquette
authors.forename: Marc
authors.initials: M
authors.lastname: Dorais
authors.forename: Lukas M
authors.initials: LM
authors.lastname: Wildi
authors.forename: François
authors.initials: F
authors.lastname: Abram
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Pelletier
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D019645:Arthroplasty, Replacement, Knee; D002097:C-Reactive Protein / Q000378:metabolism; D018450:Disease Progression; D004812:Epidemiologic Methods; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000473:pathology; D008279:Magnetic Resonance Imaging / Q000379:methods; D008297:Male; D008592:Menisci, Tibial / Q000473:pathology; D008875:Middle Aged; D009288:Naproxen / Q000627:therapeutic use; D020370:Osteoarthritis, Knee / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D011379:Prognosis; D011758:Pyrroles / Q000627:therapeutic use; D000070600:Tibial Meniscus Injuries
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D011758:Pyrroles; D009288:Naproxen; D002097:C-Reactive Protein; C088092:licofelone