Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis
Recruiting · NCT07329361 · Interventional (participants receive a specific treatment) · Lead sponsor: MiKS Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Platelet Rich Plasma
What this trial is about
Evaluation of intra-articular injections in knee osteoarthritis using frozen-stored PRP. Compared with intra-articular injections of PRP applied at the time of collection.
Who can take part
Age range
40 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Arthroscopic Surgery Unit, MiKS Hosptial - Vitoria-Gasteiz, Araba/Álava, Spain