A Randomized Placebo-Controlled Trial of Efficacy and Safety: Drug-Free Gel Containing Ultra-Deformable Phospholipid Vesicles (TDT 064) in Osteoarthritic Knees

Abstract

Background: There are a number of topical agents that are used for treatment of knee osteoarthritis. Drug-free gels, containing ultra-deformable phospholipid vesicles (TDT 064) are one such topical therapy, which have been stated to act as a bio lubricant. However, the evidence of TDT 064 in treatment of knee osteoarthritis is limited. Hence, the aim of this study was to evaluate the efficacy of pain control as a primary outcome and safety of TDT 064 compared with a topical placebo. Methods: Sixty-four patients with primary osteoarthritis, with radiographic showing Kellgren and Lawrence classification grade II to III, were randomized into 2 groups. In the first group of 32 patients TDT 064 was used as topical agent, whilst in the second group of 32 patients a placebo identical in appearance was used instead. The verbal numerical rating scale (VNRS) was used for recording pain levels, Self-reported Knee Injury and Osteoarthritis Outcome Scores (KOOS) as well as amounts of rescue medication were also recorded. The data were recorded at the start of the study, and then at follow-up appointments of 14 days, 6 weeks, and 3 months. Results: The mean VNRS for pain in both groups were significantly improved, when compared to the start of treatment (P