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Platelet-Rich Plasma, Hyaluronic Acid, or Their Combination for Knee Osteoarthritis in Athletes

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  • Are you between 18 and 75 years old?

Source: NCT07901153, who can take part

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Trial details

Who runs it
University of Sao Paulo General Hospital
Trial code
NCT07901153
Record updated
4 November 2026
Original description
The goal of this clinical trial is to learn whether a single knee injection of platelet-rich plasma (PRP) combined with hyaluronic acid (HA) works better than PRP alone or HA alone to relieve pain and improve function in physically active adults (athletes) with knee osteoarthritis. The main questions it aims to answer are:Read full original descriptionShow less

Platelet-Rich Plasma Combined With Hyaluronic Acid Versus Platelet-Rich Plasma or Hyaluronic Acid Alone in Athletes With Knee Osteoarthritis: A Prospective, Randomized, Controlled, Double-Blind Clinical Trial

The goal of this clinical trial is to learn whether a single knee injection of platelet-rich plasma (PRP) combined with hyaluronic acid (HA) works better than PRP alone or HA alone to relieve pain and improve function in physically active adults (athletes) with knee osteoarthritis. The main questions it aims to answer are:

* Does PRP combined with HA improve the WOMAC total score at 12 months more than PRP alone? * How do PRP plus HA, PRP alone and HA alone compare regarding pain, function, sports activity, global improvement, satisfaction, use of rescue medication and adverse events over 24 months?

Researchers will compare three groups: PRP plus HA, PRP alone and HA alone. The PRP will be leukocyte-poor, prepared fresh, standardized to at least 1,000,000 platelets per microliter and a total dose of at least 5 billion platelets, and fully characterized according to the MIBO checklist and the AAOS/NIH minimum reporting standards.

Participants will:

* Have a blood sample collected (all groups, so that participants do not know which treatment they receive) * Receive one ultrasound-guided injection in the target knee * Answer questionnaires (WOMAC, KOOS, IKDC, Lysholm, Tegner and pain scale) at baseline and at 3, 6, 12 and 24 months * Report any pain medication used, other treatments and side effects during follow-up

Inclusion: Age 18 to 75 years; Symptomatic primary knee osteoarthritis, with Kellgren-Lawrence grade I, II or III on a knee radiograph obtained within the previous 6 months; Knee pain in the target knee of at least 4 on a 0 to 10 visual analog scale (VAS) in the previous week; Persistent symptoms despite conservative treatment, defined as at least 3 months of physical therapy or supervised exercise, or analgesics, without satisfactory response; Regular practice of structured physical exercise for at least 6 months, with at least 150 minutes per week of moderate intensity or 75 minutes per week of vigorous intensity (World Health Organization 2020), self-reported and confirmed by the short International Physical Activity Questionnaire (IPAQ) or a Tegner activity level of 3 or higher; Signed informed consent; Only one knee per participant is treated and assessed; in bilateral disease, the most symptomatic knee is the target knee and the contralateral knee does not receive injections during follow-up.

Exclusion: Intra-articular corticosteroid injection in the target knee within the previous 6 months; Intra-articular hyaluronic acid or PRP injection in the target knee within the previous 12 months; Any previous surgery on the target knee, at any time, or planned surgery on the target knee; Mechanical locking symptoms or symptomatic ligament instability of the target knee, or a concomitant lesion with surgical indication, such as a meniscal tear with locking; Anticoagulant therapy that cannot be safely discontinued; Inability to complete the 24-month follow-up; Notes: Habitual analgesics and anti-inflammatory drugs are not exclusion criteria, as they are the study rescue medications, and their use is recorded at every visit. Nonsteroidal anti-inflammatory drugs must be discontinued 7 days before blood collection; if used within this interval, the blood collection is rescheduled; Systemic infection or infection at the injection site; Immunosuppression, due to disease or medication; Active malignancy; Allergy to hyaluronic acid or to any component used; Platelet count below 150,000/uL; Hemoglobin below 11 g/dL or other hematologic disease, including coagulopathies; Decompensated systemic disease: diabetes mellitus with HbA1c above 8%; uncontrolled hypertension (160/100 mmHg or higher at assessment); thyroid disease without laboratory control; heart failure NYHA class III or IV; chronic kidney disease on dialysis; or decompensated liver disease; Active inflammatory arthritis (such as rheumatoid arthritis) or crystal arthropathy; Severe lower limb malalignment (marked varus or valgus) on physical examination; Pregnancy; Body mass index above 40 kg/m2.

ClinicalTrials.gov NCT07901153