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Objectives and questions: To evaluate the effectiveness and safety of a single intra-articular injection of CCoat, a novel phospholipid-based liposomal lubricant, in reducing pain and improving function in patients with knee osteoarthritis by restoring mechanical cartilage protection.

Material and methods: This was a multicenter, randomized, double-blind, placebo-controlled trial. Eligible patients with Kellgren–Lawrence grade II–III knee OA received a single intra-articular injection of either CCoat or saline placebo. The primary outcome was the change in KOOS Pain score from baseline to Week 12. Secondary outcomes included changes in KOOS subscales for Symptoms, Activities of Daily Living (ADL), Sports and Recreation, and Quality of Life (QOL). The minimal clinically important difference (MCID) was defined as ≥8 points. Patients were assessed at baseline and at 1, 6-, 12-, 18-, and 26-weeks post-injection. Safety was monitored throughout the study.

Results: A total of 94 patients were enrolled. At Week 12, the CCoat group demonstrated a significantly greater improvement in KOOS Pain compared to placebo (+13.0 vs. +6.0 points; p = 0.04), exceeding the MCID. Improvements in all KOOS subscales peaked between Weeks 12–18 and remained clinically meaningful through Week 26. Placebo-treated patients showed only modest, subclinical improvements. No adverse events or safety concerns were reported.

Discussion and conclusions: A single intra-articular injection of CCoat resulted in rapid, durable, and clinically meaningful improvements in pain and function in patients with knee OA. These findings support the potential of CCoat as a safe and effective boundary lubricant therapy for symptomatic knee OA.