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Completed
NCT07857954
Comparison of Leucocyte-rich PRP and Leucocyte-poor PRP in Treating Mild to Moderate Knee Osteoarthritis.
Conditions: Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3), Knee Osteoarthritis, PRP, Platelet-rich Plasma (PRP)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 59
Sponsor: St. Catherine Specialty Hospital
Location: St. Catherine Specialty Hospital Zagreb
Summary
The purpose of this study is to show that there is no difference in patient clinical scores when patients with knee pain are treated with joint application of high dose white blood cell PRP (platelet-rich plasma) and low dose white blood cell PRP for knee osteoarthritis. Participants will be selected based on presenting knee pain lasting for 6 months or longer. Before being recruited, they will undergo radiological examinations (X-ray and MRI), based on which they will be recruited. Before application and subjection to randomization, all patients will fill out clinical questionnaires (KOOS,WOMAC,VAS). Afterwards, the participants will be divided randomly into two groups, one receiving high dose white blood cell PRP and the other group receiving low dose white blood cell PRP. Participants will not be aware of which group they are divided into. They will have blood drawn, the blood will be processed into a PRP blood product. The blood product will then be applied into the joint space with the help of ultrasound. The patients will again fill out clinical scores (KOOS,WOMAC,VAS) at the follow-up intervals (1,3,6,12 months). At the end of the study, participants will be allowed to discover which PRP product they received.
Eligibility Criteria
Inclusion Criteria:
* patients with knee osteoarthritis aged 18 to 75 years
* Kellgren-Lawrence osteoarthritis grade 1-3
* onset of knee symptoms (pain) at least 6 months prior
* ability to follow study instructions and attend follow-up visits
* signed informed consent for participation in the study
Exclusion Criteria:
* patients with malignancies, systemic inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis), or other systemic diseases that may result in knee pain
* patients with a body mass index (BMI) greater than 30 or diabetes
* patients with 6 or more painful body points, distributed above and below the waist, on both sides of the body, and in the axillary region
* patients with depression (according to the CESD-R questionnaire)
* patients with Grade 4 knee osteoarthritis according to the Kellgren-Lawrence classification
* patients with post-traumatic osteoarthritis
* patients with rheumatoid arthritis
* patients with a history of knee surgery
* patients with a mechanical axis deviation (valgus/varus) of the lower extremities greater than 5°
* patients with knee instability
* patients with damage to the meniscus or other knee structures as the primary cause of pain and other symptoms
* patients with a history of knee injury within the last 3 months
* patients with other musculoskeletal problems/diseases that would prevent clinical evaluation of the effects of PRP treatment
* patients treated with intra-articular knee injections (corticosteroids, hyaluronic acid, platelet-rich plasma, etc.) within the last 3 months
* patients with joint chondromatosis or villonodular synovitis knee
* knee joint infection
* pregnant patients or patients planning pregnancy during the study period
* history of chemotherapy or radiotherapy to the limb
* patients with mental illness (where cooperation during the project cannot be expected)
* patients determined unable to attend follow-up appointments
Source: ClinicalTrials.gov (NCT07857954). StuddyBuddy aggregates publicly available trial information.