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

NCT07785401 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-08-25

No results posted yet for this study

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 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).

Conditions

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

Interventions

DEVICE

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

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.

DEVICE

Hyaluronic Acid (HA)

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.

Sponsors & Collaborators

  • Implai Sp z o.o

    lead INDUSTRY

Principal Investigators

  • Urszula Zdanowicz, MD · Life Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2028-07-31
Completion
2028-07-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785401 on ClinicalTrials.gov