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NCT Number: NCT07785401

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

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).

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Knee Osteoarthritis (Knee OA) Knee Osteoarthritis (OA) Musculoskeletal Diseases Osteoarthritis Osteoarthritis (OA) of the Knee Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Life Medical Center

Warsaw, Masovian Voivodeship, 00-855, Poland

Location status: Recruiting

Location contact

Urszula Zdanowicz, MD

CONTACT

[email protected]

+48 788 122 188

Urszula Zdanowicz, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Knee osteoarthritis meeting American College of Rheumatology (ACR) criteria
  • Kellgren-Lawrence radiographic grade II or III
  • Pain intensity in the study knee NRS >= 4 and in the contralateral knee NRS <= 2
  • Written informed consent

Exclusion criteria

  • BMI >= 40 kg/m2
  • Surgery of the same or contralateral knee within the previous year
  • Intra-articular corticosteroid injection into the study joint within 3 months, or hyaluronic acid, platelet-rich plasma or other intra-articular injection therapy within 6 months before enrolment
  • Systemic corticosteroid use within 2 weeks
  • Systemic inflammatory or autoimmune disease with joint involvement (rheumatoid arthritis, spondyloarthropathy, systemic lupus erythematosus, etc.)
  • Oral corticosteroid treatment
  • Deep vein thrombosis
  • Pregnancy or breastfeeding

Treatment and study plan

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.

Primary outcomes

  1. Change in knee pain intensity on the Numeric Rating Scale (NRS)

    Time frame: Baseline to 6 months]

    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.

Secondary outcomes

  1. Change in knee pain intensity as measured by the Numeric Rating Scale (NRS) at additional time points

    Time frame: Baseline, 1, 3, 12 and 18 months

    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.

  2. Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores

    Time frame: Baseline, 1, 3, 6, 12 and 18 months

    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.

  3. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale scores

    Time frame: Baseline to 18 months

    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.

  4. Number of participants with at least one treatment-emergent adverse event (AE)

    Time frame: Baseline to 18 months

    Number of participants experiencing at least one adverse event (AE) of any grade after the study injection, as recorded at every study visit.

  5. Number of treatment-emergent adverse events (AEs)

    Time frame: Baseline to 18 months

    Total count of adverse events (AEs) reported after the study injection, summarised by event type.

  6. Number of participants discontinuing the study due to an adverse event (AE)

    Time frame: Baseline to 18 months

    Number of participants who did not complete the study because of an adverse event (AE).

Study contacts

Contact information is provided by the study sponsor or research team.

Eliza Fiedorczuk

CONTACT

[email protected]

+48 58 660 44 88

Sponsors and collaborators

Lead sponsor

Implai Sp z o.o

Industry

Registry information

Official study title

Effect of Adding Platelet-Rich Plasma to Hyaluronic Acid on Outcomes of Injection Therapy for Knee Osteoarthritis: A Prospective, Randomized Comparative Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 25, 2026
Registry last updated
Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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