| Summary: | 碩士 === 逢甲大學 === 生醫資訊暨生醫工程碩士學位學程 === 97 === Background: Viscosupplementation with 3 to 5 weekly hyaluronate injections is a well-established treatment option in knee osteoarthritis. Previous studies reported that five weekly hyaluronate injections were safe and effective for the treatment of ankle osteoarthritis. However, the effect of three weekly injections has rarely been investigated. The purpose of this study was to evaluate the efficacy and safety of three weekly injections of sodium hyaluronate (Hyalgan) in patients with unilateral ankle osteoarthritis.
Methods: As a prospective observer-blind study done in a university-affiliated tertiary care medical center, 50 patients with unilateral ankle pain for at least 6 months and radiographically classified as Kellgren-Lawrence grade 2 or 3 ankle osteoarthritis were recruited. Patients received three weekly intraarticular injections of Hyalgan into symptomatic ankles. The primary outcome was the change in the Ankle Osteoarthritis Scale (AOS) score at 6 months after the third injection. Several secondary outcomes including the American Orthopedic Foot and Ankle Society ankle/hindfoot score, ankle sagittal range of motion and four clinical balance tests were assessed before first injection and at each follow-up visit. Consumption of rescue analgesics, patients’ global satisfaction and adverse events were analyzed also.
Results: Forty-six participants completed the study. Significantly greater reduction in AOS scores by more than 1 was noted at 1, 3 and 6 months after the third injection (p < 0.001 for each following visit compared with baseline before first injection). The average reduction of AOS score was 1.9, 2.1 and 2.3 at each following visit. The mean American Orthopedic Foot and Ankle Society ankle/hindfoot score improved from 60.5 points at baseline to 73.5, 75.5 and 76.7 points at 1-month, 3-month and 6-month follow-up, respectively (p < 0.001). Ankle sagittal range of motion improved and acetaminophen consumption dropped significantly following treatment (p < 0.001). Patients demonstrated significant improvements in four clinical balance tests at each follow-up visit compared with baseline (p<0.001 for each test). The patients’ satisfaction requires confirmation in larger, well-controlled trial.
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