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Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial
Led by MiKS Hospital · Updated on 2026-01-09
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of intra-articular injections of platelet-rich plasma (PRP) in patients with knee osteoarthritis. The study compares frozen-stored PRP injections to fresh PRP injections applied at the time of collection. This randomized, double-blind trial aims to assess the efficacy and safety of these treatments in adults aged 40 to 85 years diagnosed with knee osteoarthritis. Participants receive either frozen platelet-rich plasma or fresh platelet-rich plasma injected into the knee joint. The treatments are administered according to a randomized assignment, maintaining blinding for both participants and researchers. The study is conducted by MiKS Hospital and includes follow-up evaluations to monitor outcomes over several months. During the study, participants will undergo assessments including the Knee Injury and Osteoarthritis Outcome Score (KOOS) at 2 and 6 months, the Visual Analog Scale (VAS) for pain at 2 and 6 months, and the Lequesne Index at both time points. These measures help evaluate pain, function, and severity of osteoarthritis. Participants will be monitored for safety and adherence throughout the follow-up period, which extends up to 6 months after treatment.
CONDITIONS
Brief Title
Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive intra-articular injections of either frozen platelet-rich plasma or fresh platelet-rich plasma for knee osteoarthritis.
Multiple visits for injections and assessments over 6 months
Trial Site Locations
Total: 1 location
1
Arthroscopic Surgery Unit, MiKS Hosptial
Vitoria-Gasteiz, Araba/Álava, Spain, 01010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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