Menu
Recruiting NCT07329361

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

No phase Interventional Knee Osteoarthristis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Platelet Rich Plasma, Platelet Rich Plasma.
Who it may be relevant to
Registry conditions: Knee Osteoarthristis. Basic parameters: 40 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Other Platelet Rich Plasma
    Platelet-rich plasma stored by freezing
  • Other Platelet Rich Plasma
    Fresh Platelet-Rich Plasma

Primary outcome measures

  • KOOS - Knee Injury and Osteoarthritis Outcome Score [Time frame: 6 months]
Secondary outcome measures (5)
  • KOOS - Knee Injury and Osteoarthritis Outcome Score [Time frame: 2 months]
  • VAS - Visual Analog Scale [Time frame: 2 months]
  • VAS - Visual Analog Scale [Time frame: 6 months]
  • Lequesne Index [Time frame: 2 months]
  • Lequesne Index [Time frame: 6 months]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Arthroscopic Surgery Unit, MiKS Hosptial — Vitoria-Gasteiz

Identifiers

NCT: NCT07329361 · UCA-17/EC/25/CON

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗