This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III). Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone. A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months. The primary endpoint is the between-group difference in change in knee pain measured using the Numeric Rating Scale (NRS) from baseline to Month 6. Secondary outcomes include changes in pain intensity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee injury and Osteoarthritis Outcome Score (KOOS), quality of life measures, and safety assessments throughout the follow-up period. Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Procedure kit enabling preparation of autologous platelet-rich plasma (PRP) from the participant's venous blood and intra-articular administration combined with sodium hyaluronate. The procedure includes preparation of PRP using a separation device and injection of a total volume of 4.8 mL consisting of 3.8 mL of 2.5% sodium hyaluronate and 1 mL of autologous PRP.
Pre-filled syringe containing 4.8 mL of sterile, nonpyrogenic hyaluronic acid gel for intra-articular injection. The product contains sodium hyaluronate at a concentration of 25 mg/mL (total dose: 120 mg), produced by bacterial fermentation and of non-animal origin.
Life Medical Center
Warsaw, Masovian Voivodeship, Poland
RECRUITINGChange in knee pain intensity on the Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) for pain is an 11-point single-item scale on which the participant rates knee pain intensity over the past week from 0 (no pain) to 10 (worst imaginable pain). The outcome is the between-group difference in change from baseline; a greater decrease indicates greater improvement.
Time frame: Baseline to 6 months]
Change in knee pain intensity as measured by the Numeric Rating Scale (NRS) at additional time points
The Numeric Rating Scale (NRS) for pain ranges from 0 (no pain) to 10 (worst imaginable pain). Change from baseline is reported; a decrease indicates improvement.
Time frame: Baseline, 1, 3, 12 and 18 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of three subscales: Pain, Stiffness, and Physical Function. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse pain, stiffness, and physical function. The Pain subscale ranges from 0 to 20, the Stiffness subscale from 0 to 8, and the Physical Function subscale from 0 to 68. Change from baseline will be assessed for the total WOMAC score and each subscale score. A decrease in score indicates improvement.
Time frame: Baseline, 1, 3, 6, 12 and 18 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale scores
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five subscales: Symptoms, Pain, Activities of Daily Living, Sport and Recreation, and Knee-related Quality of Life. Each subscale is normalised to a 0-100 scale, where 0 indicates extreme knee problems and 100 indicates no knee problems. Change from baseline will be assessed for each KOOS subscale; an increase in score indicates improvement.
Time frame: Baseline to 18 months
Number of participants with at least one treatment-emergent adverse event (AE)
Number of participants experiencing at least one adverse event (AE) of any grade after the study injection, as recorded at every study visit.
Time frame: Baseline to 18 months
Number of treatment-emergent adverse events (AEs)
Total count of adverse events (AEs) reported after the study injection, summarised by event type.
Time frame: Baseline to 18 months
Number of participants discontinuing the study due to an adverse event (AE)
Number of participants who did not complete the study because of an adverse event (AE).
Time frame: Baseline to 18 months
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