Background/Purpose: OA is a leading cause of disability in the US. Although no disease-modifying therapies exist, patients with knee OA who walk 6,000 steps/day or more reduce the risk of developing a functional limitation within the next 2 years by half.¹ The purpose of this study is to demonstrate the impact of a mobile application (OA GO) plus wearable activity monitor/pedometer in increasing the mobility of knee OA patients who were treated with hylan G-F 20.

Methods: This was a multicenter, open-label study in knee OA patients treated with a single 6-ml injection of hylan G-F 20 and randomized 1:1 to unblinded wearable activity monitor and OA GO (Group A; n=107) or blinded wearable activity monitor only (Group B; n=104). Participants were aged 30 to 80 years, were eligible to receive hylan G-F 20 per US labeling, and were familiar with smartphone technology. Outcome measures included mean number and percent change from baseline in steps/day, pain and distance of 6-minute walk test, patient/physician satisfaction surveys, Patient Activation Measure (PAM-13), and adverse events (AEs) at 90 days. Descriptive statistics were used to compare baseline characteristics and least square means were used to compare changes from baseline.

Results: Baseline characteristics were similar between groups. In both groups, significant increases in mean number and percent change of steps/day from baseline were observed; a significantly greater improvement in both outcomes was observed for Group A versus Group B (1199 vs 467, P=.0345 for number of steps/day; 35.81 vs 11.48, P=0.0189 for percent change of steps/day). In the 6-minute walk test, there was a greater improvement from baseline for Group A versus Group B in reducing pain (−55.3% vs −33.8%, P=0.0068) and increasing distance (18.2% vs 6.3%, P=0.9583). There was a greater number of patients (65.4%)/physicians (67.3%) who would be likely/very likely to use/recommend the devices than those who would be unlikely to do so. In both groups, PAM-13 scores improved from baseline however, no statistically significant differences were observed between groups (5.0% vs 6.9%, P=0.9931). The AE profiles were similar for the two arms.

Conclusion: In this study, both groups were treated with hylan G-F 20 and showed significantly increased mobility and reduced pain, however, patients using the wearable activity monitor and OA GO mobile application had significantly improved mobility over controls without adding safety concerns. Overall, patient use of a novel smartphone application in conjunction with a wearable activity monitor enhanced the efficacy imparted by hylan G-F 20 treatment for knee OA in steps per day and pain with walking in the 6-minute walk test. Sanofi provided funding for the study.   ¹White DK, Tudor-Locke C, Zhang Y, Fielding R, LaValley M, Felson DT, et al. Daily walking and the risk of incident functional limitation in knee OA: An observational study. Arthritis Care Res (Hoboken). 2014;66:1328-36.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/impact-of-novel-smartphone-application-on-pain-and-mobility-in-osteoarthritis-patients-treated-with-hylan-g-f-20/