Frozen versus fresh platelet-rich plasma injections for knee osteoarthritis
Official title: Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial
Run by MiKS Hospital · NCT07329361 · Data updated 2026-11-12
This trial will test whether frozen-stored PRP injections work as well as PRP given at the time of collection to reduce pain and improve function in people aged 40–85 with knee osteoarthritis.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 40 Years to 85 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | MiKS Hospital Academic / other |
| Locations | 1 site (Vitoria-Gasteiz, Araba/Álava) |
| Status | Recruiting |
| Started | December 16, 2025 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | January 9, 2026 |
| Trial ID | NCT07329361 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 40–85 with radiographic knee osteoarthritis (Ahlbäck grades 1–3), KOOS pain ≤75, BMI between 20 and 35, and who are candidates for intra-articular PRP injections are ideal candidates.
✕Probably not a fit
Patients with BMI >35, systemic autoimmune rheumatic disease, recent intra-articular steroid/PRP or hyaluronic acid injections within the exclusion windows, severe mechanical deformity, hematologic disorders, or active infectious serology are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants with radiographically confirmed knee osteoarthritis and symptomatic pain will receive intra-articular injections of platelet-rich plasma prepared either from frozen-stored samples or applied at the time of collection. The two injection approaches will be compared for safety and clinical outcomes such as pain and function over a defined follow-up period. Key eligibility includes age 40–85, BMI 20–35, Ahlbäck radiological grades 1–3, and KOOS pain ≤75. Patients with recent intra-articular corticosteroid/PRP injections, systemic autoimmune disease, significant deformity, or hematologic disorders are excluded.
Why it matters
Potential benefit: If successful, frozen PRP could offer similar symptom relief while allowing easier storage, scheduling, and wider availability of PRP treatments.
How similar studies have gone: Previous studies show PRP can reduce pain and improve function in knee osteoarthritis, but the use of frozen-stored PRP is less studied and evidence for equivalence to fresh PRP is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of both sexes. * Aged between 40 and 85 years old. * Diagnosed with osteoarthritis through clinical radiological examination. * Joint pain equal to or less than 75 points on the KOOS (pain). * Radiological severity grades 1, 2, and 3 according to the Ahlbäck scale. * Indication for intra-articular PRP infiltration. * Body Mass Index values between 20 and 35. * Negative serological tests for syphilis, HIV, HBV, and HCV. * Possibility of observation during the follow-up period. * Signature of informed consent. Exclusion Criteria: * Body mass index \>35 * Diagnosed polyarticular disease. * Previous arthroscopy in the last year. * Severe mechanical deformity. * Intra-articular hyaluronic acid injection in the last 12 months. * Intra-articular corticosteroid or PRP injection in the last 6 months. * Systemic autoimmune rheumatic disease (connective tissue diseases and systemic necrotizing vasculitis). * Anemia or other hematological disorders. * Positive serological tests for SYPHILIS, HIV, HBV, and HCV. * Undergoing immunosuppressive treatments. * Poorly controlled diabetes mellitus. * Patients allergic to paracetamol. * Pregnancy or breastfeeding.
Where it's running
-
Arthroscopic Surgery Unit, MiKS Hosptial
Vitoria-Gasteiz, Araba/Álava, Spain Recruiting
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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.