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

M

MiKS Hospital

Status

Enrolling

Conditions

Knee Osteoarthristis

Treatments

Other: Platelet Rich Plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT07329361
UCA-17/EC/25/CON

Details and patient eligibility

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.

Enrollment

60 estimated patients

Sex

All

Ages

40 to 85 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

Frozen Platelet-Rich Plasma
Experimental group
Treatment:
Other: Platelet Rich Plasma
Other: Platelet Rich Plasma
Platelet-Rich Plasma
Active Comparator group
Treatment:
Other: Platelet Rich Plasma
Other: Platelet Rich Plasma

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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