RecruitingNot ApplicableNCT07329361

Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis

Efficacy and Safety of Intra-articular Injections of Frozen Platelet-Rich Plasma in Patients With Knee Osteoarthritis: Randomized Control Trial


Sponsor

MiKS Hospital

Enrollment

60 participants

Start Date

Dec 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Inclusion Criteria10

  • 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 Criteria13

  • 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.

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Interventions

OTHERPlatelet Rich Plasma

Platelet-rich plasma stored by freezing

OTHERPlatelet Rich Plasma

Fresh Platelet-Rich Plasma


Locations(1)

Arthroscopic Surgery Unit, MiKS Hosptial

Vitoria-Gasteiz, Araba/Álava, Spain

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NCT07329361


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