Efficacy of Platelet-Rich Plasma Combined With Hyaluronic Acid in Knee Osteoarthritis

NCT07784907 | Recruiting

• 1 other identifier: 2.0 17.02.2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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 the change in knee pain, measured using the Numeric Rating Scale (NRS), from baseline to Month 6. Secondary outcomes include changes in pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the 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).

Conditions

Knee Osteoarthritis; Knee Osteoarthritis (Knee OA); Knee Osteoarthritis (OA); Osteoarthritis (OA) of the Knee

Keywords

hyaluronic acid; PRP; HA; intra-articular injection; Single intra-articular injection; knee osteoarthritis; viscosupplementation; Hyaluronic acid and platelet-rich plasma

Outcome Measures

Primary Outcomes (1)

• Change 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.

  Baseline to 6 months

Secondary Outcomes (6)

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

  Baseline, 1, 3, 12 and 18 months

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

  Baseline, 1, 3, 6, 12 and 18 months

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

  Baseline to 18 months

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

  Baseline to 18 months

• Number of treatment-emergent adverse events (AEs)

  Baseline to 18 months]

Study Arms (2)

Hyaluronic acid with autologous plateletrich plasma

EXPERIMENTAL

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).

Device: Hyaluronic Acid (HA) and Platelet rich plasma (PRP)

Hyaluronic acid

ACTIVE COMPARATOR

Single intra-articular knee injection of 4.8 mL hyaluronic acid gel containing sodium hyaluronate (25 mg/mL; total dose: 120 mg).

Device: Hyaluronic Acid (HA)

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 with autologous plateletrich plasma

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.

Hyaluronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Implai Sp z o.o: lead

Study Sites (1)

Przychodnia Specjalistyczna Lancet

Chełm, Lublin Voivodeship, 22-100, Poland

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jaromir Jarecki, DSc

  Przychodnia Specjalistyczna Lancet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eliza Fiedorczuk

CONTACT

+48 58 660 44 88; clinical@implai.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 25, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)