Efficacy of Platelet-Rich Plasma Added to Hyaluronic Acid in Knee Osteoarthritis

Sponsor
Implai Sp z o.o
Study ID
NCT07785401
Status
Recruiting
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Conditions

  • Knee Osteoarthritis
  • Knee Osteoarthritis (Knee OA)
  • Knee Osteoarthritis (OA)
  • Osteoarthritis (OA) of the Knee

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Hyaluronic Acid (HA) and Platelet rich plasma (PRP) — DEVICE
    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.
  • Hyaluronic Acid (HA) — DEVICE
    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.

Study Details

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).

Key Dates

First listed
Aug 25, 2026
Start date
Jul 20, 2026
Status verified
Aug 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Hyaluronic acid with autologous plateletrich plasma
    Single intra-articular knee injection of 3.8 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP), prepared from 13.5 mL of the participant's venous blood using the PRP separation device (total injection volume: 4.8 mL).
  • Active Comparator: Hyaluronic acid
    Single intra-articular knee injection of 4.8 mL hyaluronic acid gel containing sodium hyaluronate (25 mg/mL; total dose: 120 mg).

Primary Outcome Measure

Change in knee pain intensity on the Numeric Rating Scale (NRS) [ Time Frame: Baseline to 6 months] ]

Central Contacts

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