Medial Knee Osteoarthritis Treated by Insoles or Braces: A Randomized Trial

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. QUESTIONS/PURPOSES: We therefore asked whether laterally wedged insoles or valgus braces would reduce pain, enhance functional scores, and correct varus malalignment comparable to knee braces. PATIENTS AND 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. LEVEL OF EVIDENCE: Level I, therapeutic study. See the Guidelines for Authors for a complete description of level of evidence.