Frozen versus fresh platelet-rich plasma injections for knee osteoarthritis
Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 40 Years to 85 Years |
| Sex | All |
| Sponsor | MiKS Hospital Academic / other |
| Locations | 1 site (Vitoria-Gasteiz, Araba/Álava) |
| Trial ID | NCT07329361 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Vitoria-Gasteiz, Araba/Álava
- Arthroscopic Surgery Unit, MiKS Hosptial — Vitoria-Gasteiz, Araba/Álava, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.