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

RecruitingNAAges 18 Years - anyAllImplai Sp z o.o
NCT07785401 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 part

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📋 Eligibility rules (as published)
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
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What it tests

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

1 site
Life Medical Center
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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