Platelet-rich plasma added to hyaluronic acid for knee osteoarthritis
Official title: Effect of Adding Platelet-Rich Plasma to Hyaluronic Acid on Outcomes of Injection Therapy for Knee Osteoarthritis: A Prospective, Randomized Comparative Study
Run by Implai Sp z o.o · NCT07785401 · Data updated 2026-11-12
This study tests whether a single injection of hyaluronic acid plus autologous platelet-rich plasma helps reduce knee OA symptoms more than hyaluronic acid alone in adults with moderate knee OA.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Implai Sp z o.o Industry-sponsored |
| Locations | 1 site (Warsaw, Masovian Voivodeship) |
| Status | Recruiting |
| Started | July 20, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07785401 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with symptomatic knee OA meeting ACR criteria and KL grade II or III, with adequate pain scores and consent
✕Probably not a fit
Patients with knee OA outside KL II/III or with recent intra-articular injections or other exclusion criteria may not benefit
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, open-label, single-centre PMCF study compares a single intra-articular injection of hyaluronic acid combined with autologous platelet-rich plasma to hyaluronic acid alone in adults with knee osteoarthritis (KL grade II/III). Participants are randomized 1:1 and followed to assess safety and clinical performance of the combination therapy. The trial aims to determine if adding PRP provides additional symptom relief or functional improvement beyond HA alone. Key outcomes include patient-reported pain and function, with safety monitoring for adverse events after injection. The study is conducted at Life Medical Center in Warsaw and is sponsored by Implai Sp z o.o.
Why it matters
Potential benefit: If successful, patients may experience greater pain relief and improved knee function with the HA+PRP combination
How similar studies have gone: Prior research suggests potential additive effects of PRP with HA, but results vary and this PMCF study adds real-world data for safety and efficacy
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Life Medical Center
Warsaw, Masovian Voivodeship, Poland Recruiting
Study contacts
- Principal investigator: Urszula Zdanowicz, MD — Life Medical Center
- Study coordinator: Eliza Fiedorczuk
- Email: clinical@implai.com
- Phone: +48 58 660 44 88
Similar studies
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.