title: Medial knee osteoarthritis treated by insoles or braces: a randomized trial.
abstract: BACKGROUND
  There is controversial evidence regarding whether foot orthoses or knee braces improve pain and function or correct malalignment in selected patients with osteoarthritis (OA) of the medial knee compartment. However, insoles are safe and less costly than knee bracing if they relieve pain or improve function.
  
  
  OBJECTIVE
  We therefore asked whether laterally wedged insoles or valgus braces would reduce pain, enhance functional scores, and correct varus malalignment comparable to knee braces.
  
  
  METHODS
  We prospectively enrolled 91 patients with symptomatic medial compartmental knee OA and randomized to treatment with either a 10-mm laterally wedged insole (index group, n = 45) or a valgus brace (control group, n = 46). All patients were assessed at 6 months. The primary outcome measure was pain severity as measured on a visual analog scale. Secondary outcome measures were knee function score using WOMAC and correction of varus alignment on AP whole-leg radiographs taken with the patient in the standing position. Additionally, we compared the percentage of responders according to the OMERACT-OARSI criteria for both groups.
  
  
  RESULTS
  We observed no differences in pain or WOMAC scores between the two groups. Neither device achieved correction of knee varus malalignment in the frontal plane. According to the OMERACT-OARSI criteria, 17% of our patients responded to the allocated intervention. Patients in the insole group complied better with their intervention. Although subgroup analysis results should be translated into practice cautiously, we observed a slightly higher percentage of responders for the insole compared with bracing for patients with mild medial OA.
  
  
  CONCLUSIONS
  Our data suggest a laterally wedged insole may be an alternative to valgus bracing for noninvasively treating symptoms of medial knee OA.
  
  
  METHODS
  Level I, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence.
authors.affiliation: Department of Orthopaedics, HS-105, Erasmus University Medical Center, PO Box 2040, 3000 CA, Rotterdam, The Netherlands. t.vanraaij@mac.com
authors.forename: Tom M
authors.initials: TM
authors.lastname: van Raaij
authors.forename: Max
authors.initials: M
authors.lastname: Reijman
authors.forename: Reinoud W
authors.initials: RW
authors.lastname: Brouwer
authors.forename: Sita M A
authors.initials: SM
authors.lastname: Bierma-Zeinstra
authors.forename: Jan A N
authors.initials: JA
authors.lastname: Verhaar
mesh_terms: D017760:Bone Malalignment / Q000150:complications / Q000473:pathology / Q000628:therapy*; D001915:Braces / Q000191:economics; D004867:Equipment Design; D005260:Female; D006304:Health Status; D006801:Humans; D007719:Knee Joint / Q000000981:diagnostic imaging / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000150:complications / Q000473:pathology / Q000628:therapy*; D010146:Pain / Q000209:etiology / Q000503:physiopathology; D059408:Pain Management; D010147:Pain Measurement; D011446:Prospective Studies; D011788:Quality of Life; D011859:Radiography; D020127:Recovery of Function; D012720:Severity of Illness Index; D012775:Shoes; D016896:Treatment Outcome