BACKGROUND: Osteoarthritis (OA) is a leading cause of disability in the United States. Although no disease-modifying therapies exist, patients with knee OA who increase walking may reduce risk of functional limitations. OBJECTIVE: The objective of the study is to evaluate the impact of a mobile app (OA GO) plus wearable activity monitor/pedometer (Jawbone UP 24) used for 90 days on the mobility of patients with knee OA treated with hylan G-F 20. METHODS: Patients with knee OA aged 30 to 80 years who were eligible to receive hylan G-F 20 and were familiar with smartphone technology were enrolled in this randomized, multicenter, open-label study. Patients who had a body mass index above 35 kg/m2 were excluded. All patients received a single 6-mL injection of hylan G-F 20 and wore the Jawbone monitor. The patients were then randomized 1:1 to Jawbone and OA GO (group A; n = 107) with visible feedback (unblinded) or Jawbone only (group B; n = 104) with no visible feedback (blinded). The primary endpoint was mean change from baseline in steps per day at day 90 between groups A and B. RESULTS: Baseline characteristics were similar between groups. There were significant differences between the increases in least squares (LS) mean number of steps per day (1,199 versus 467, p = 0.03) and the mean percentage change (35.8% versus 11.5%, p = 0.02) from baseline in favor of group A over group B. There was a greater reduction in pain from baseline during the 6-minute walk test in group A versus group B. (LS mean change -55.3 versus -33.8, p = 0.007). Most patients (65.4%) and surveys of physicians (67.3%) reported they would be likely or very likely to use/recommend the devices. Patient Activity Measure-13 scores improved from baseline (LS mean change for groups A and B 5.0 versus 6.9), with no significant differences between groups. The occurrence of adverse events was similar in the 2 groups. CONCLUSIONS: Use of a novel smartphone app in conjunction with a wearable activity monitor provided additional improvement on mobility parameters such as steps per day and pain with walking in the 6-minute walk test in patients with knee OA who were treated with hylan G-F 20. Results also highlight the amenability of patients and physicians to using mobile health technology in the treatment of OA and suggest further study is warranted.

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