Mid-Term Effectiveness of Ozone (O₂-O₃) Compared to Platelet-Rich Plasma (PRP) in the Management of Knee Osteoarthritis: A Randomized Parallel Controlled Trial

Abstract

Objectives: A randomized parallel controlled trial was designed to compare efficacy of ozone (O2-O3) against platelet-rich plasma (PRP) as intra-articular infiltrations in knee osteoarthritis (OA) patients. Methods: Tertiary-level outpatient rehabilitation service. Subjects: Fifty-four patients with knee OA grades 2a - 4a according to Kellgren-Lawrence scale were included after obtaining an informed consent. The target sample size was 27 patients per group. Intervention: Patients received four ozone (intervention group) or three platelet-rich plasma (control group) intra-articular infiltrations at a one-week interval. Outcome measures: Patients were clinically and functionally evaluated by visual analogue scale (VAS pain) and by Western Ontario and Mac Master index for osteoarthritis (WOMAC) at baseline and at two months follow-up. Pain, stiffness, function, and quality of life (QoL) were evaluated outcome variables. Results: Overall, 27 patients were randomly allocated to the intervention group (ozone) and 27 to the control group (PRP). Improvement in pain, function, and QoL were observed in both groups without a statistical difference (P > 0.05). Stiffness improvement was significant between similar and different treatment groups (P < 0.05). No side-effects were observed in either group. Conclusions: Ozone (O2-O3) is as effective as PRP in the management of knee OA. Both interventions improved pain, function, and QoL with no statistical difference between them.