title: Clinical effectiveness and safety of a distraction-rotation knee brace for medial knee osteoarthritis.
abstract: OBJECTIVE
  Evaluation of the clinical effectiveness and safety of a new custom-made valgus knee brace (OdrA) in medial knee osteoarthritis (OA) in terms of pain and secondary symptoms.
  
  
  METHODS
  Open-label prospective study of patients with symptomatic medial knee OA with clinical evaluation at 6 and 52 weeks (W6, W52). We systematically assessed pain on a visual analog scale (VAS), Knee injury and Osteoarthritis Outcome Score (KOOS), spatio-temporal gait variables, use of nonsteroidal anti-inflammatory drugs (NSAIDs) and analgesic-sparing effects of the brace and tolerance. Mean scores were compared at baseline, W6 and W52 and the effect size (ES) and 95% confidence intervals (95% CIs) were calculated.
  
  
  RESULTS
  We included 20 patients with knee OA (mean age 64.2±10.2 years, mean body mass index 27.2±5.4 kg/m2). VAS pain and KOOS were improved at W6 and W52: pain (ES=0.9 at 1 year), amelioration of other symptoms (ES=0.4), and function in activities of daily living (ES=1.1), sports and leisure (ES=1.5), quality of life (ES=0.9) and gait speed (ES=0.41). In total, 76% of patients showed clinical improvement at 1 year. Analgesic and NSAIDs consumption was significantly decreased at W6 and W52. One serious adverse effect noted was lower-limb varices, and observance was deemed satisfactory at 1 year.
  
  
  CONCLUSIONS
  This new unloader brace appeared to have good effect on medial knee OA, with an acceptable safety profile and good patient compliance.
authors.affiliation: Service de rhumatologie, CHU Bocage, 21078 Dijon, France; Inserm U1093, université de Bourgogne, 21079 Dijon, France. Electronic address: paul.ornetti@chu-dijon.fr.
authors.forename: P
authors.initials: P
authors.lastname: Ornetti
authors.affiliation: Service de rhumatologie, centre hospitalier William-Morey, 71321 Chalon-sur-Saône, France.
authors.forename: C
authors.initials: C
authors.lastname: Fortunet
authors.affiliation: CIC-P Inserm 803, plateforme d'investigation technologique, CHU de Dijon, 21078 Dijon, France.
authors.forename: C
authors.initials: C
authors.lastname: Morisset
authors.affiliation: Inserm U1093, université de Bourgogne, 21079 Dijon, France; Service de médecine physique et réadaptation, CHU de Dijon, 21078 Dijon, France.
authors.forename: V
authors.initials: V
authors.lastname: Gremeaux
authors.affiliation: Service de rhumatologie, CHU Bocage, 21078 Dijon, France; Inserm U1093, université de Bourgogne, 21079 Dijon, France.
authors.forename: J F
authors.initials: JF
authors.lastname: Maillefert
authors.affiliation: Inserm U1093, université de Bourgogne, 21079 Dijon, France; Service de médecine physique et réadaptation, CHU de Dijon, 21078 Dijon, France.
authors.forename: J M
authors.initials: JM
authors.lastname: Casillas
authors.affiliation: Inserm U1093, université de Bourgogne, 21079 Dijon, France; CIC-P Inserm 803, plateforme d'investigation technologique, CHU de Dijon, 21078 Dijon, France.
authors.forename: D
authors.initials: D
authors.lastname: Laroche
mesh_terms: D000203:Activities of Daily Living; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D001915:Braces; D004867:Equipment Design; D005260:Female; D006801:Humans; D007719:Knee Joint / Q000503:physiopathology; D008297:Male; D017888:Medial Collateral Ligament, Knee / Q000503:physiopathology; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000503:physiopathology / Q000628:therapy*; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D012399:Rotation; D016896:Treatment Outcome; D000072797:Walking Speed
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal
keywords: Effectiveness; Gait analysis; Knee osteoarthritis; Safety; Unloader brace; Valgus