Impact of a Novel Smartphone Application on Pain and Mobility in Osteoarthritis Patients Treated with Hylan G-F 20

author.DisplayName 1 author.DisplayName 2 author.DisplayName 3 author.DisplayName 4 author.DisplayName 5 author.DisplayName 6
1Orthopaedic Center, Cedars-Sinai Orthopedic Center, USA
2Orthopaedic Surgery, Tucson Orthopaedic Institute, USA
3Department of Medicine, UCLA Medical Center, USA
4Internal Medicine, National Clinical Research–Richmond, USA
5Biostatistics, Sanofi, Canada
6Global Medical Affairs Immuno-Inflammation, Sanofi, USA

Introduction: Osteoarthritis (OA) is a leading cause of disability in the US. Knee OA patients who increase walking may reduce the risk of functional limitations. We studied the impact of a mobile application (OA GO) plus wearable activity monitor/pedometer (Jawbone® UP 24™) in increasing mobility of knee OA patients treated with hylan G-F 20.

Methods: This was an open-label, multicenter, randomized, parallel-group study in knee OA patients treated with a single 6-ml hylan G-F 20 injection, randomized 1:1 to unblinded Jawbone+OA GO (Group A;n=107) or blinded Jawbone only (Group B;n=104). Patients were 30-80 years, eligible to receive hylan G-F 20, and familiar with smartphone technology. Outcomes included mean number and %,change from baseline in steps/day, pain and distance of 6-minute walk test, patient/physician satisfaction, Patient Activation Measure (PAM-13), and adverse events (AEs) at 90 days. Comparisons used descriptive statistics for baseline characteristics and least square means for changes from baseline.

Results: Baseline characteristics were similar. Both groups significantly increased mean number and %,change of steps/day from baseline; significantly greater improvement in both outcomes occurred for Group A versus Group B (1199 vs 467[P=.0345] for number of steps/day; 35.81 vs 11.48[P=.0189] for %,change of steps/day). For 6-minute walk test, there was greater improvement from baseline for Group A versus Group B in reducing pain (−55.3% vs −33.8%[P=.0068]) and increasing distance (18.2% vs 6.3%[P=.9583]). Most patients (65.4%)/physicians (67.3%) were likely or very likely to use/recommend the devices. In both groups, PAM-13 scores improved from baseline, however, no statistically significant differences were observed between groups (5.0% vs 6.9%, P=.9931). AE profiles for both were similar.

Conclusions: Both groups treated with hylan G-F 20 showed significantly increased mobility and reduced pain; however, patients using the Jawbone+OA GO mobile application had significantly improved mobility over controls without adding safety concerns. Sanofi sponsored the study.









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