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NCT05825105 | RECRUITING | Knee Osteoarthritis

Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis
Sponsor:

National University of Entre Rios

Information provided by (Responsible Party):

Pablo Schirloh

Brief Summary:

Osteoarthritis (OA) is a disease that affects the joints of the body, causing pain, stiffness, and reduced mobility. To treat knee OA, a therapy called platelet-rich plasma (PRP) is used, which involves making a concentrated substance from the patient's own blood and injecting it into the joint. It has been shown that this therapy is effective in reducing pain; however, more research is needed to optimize the preparation and identify which patients are more receptive to the treatment. The primary objective of this study is to evaluate two modalities of PRP application and determine whether these treatments result in better pain reduction and improved functionality. The secondary objective is to explore the association between changes in LEFS questionnaire scores and/or maximal quadriceps isometric strength and possible clinical improvement.

Condition or disease

Knee Osteoarthritis

Intervention/treatment

Platelet-Rich Plasma

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 110 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Platelet rich plasma effectiveness (PRP) for the objective decrease in pain and the functional recovery of the lower limb in knee osteoarthritis. Evaluation of methodological alternatives
Actual Study Start Date : 2024-05-01
Estimated Primary Completion Date : 2025-09
Estimated Study Completion Date : 2025-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 35 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Radiological diagnosis of knee OA
  • * Age over 35 years old
  • * WOMAC value of 24 or higher at the time of recruitment
Exclusion Criteria
  • * Patients with knee prosthesis, rheumatoid arthritis, contralateral lower limb amputation, any type of blood dyscrasia, hypofibrinogenemia, depot pool syndrome, or any other form of thrombocytopathy or chronic leukocytosis will be excluded from the study.
  • * Patients with anticoagulant or acute coagulopathies, as well as carriers of any infectious disease or superficial infection at the puncture site, will be temporarily excluded from the study until their clinical recovery is confirmed by laboratory testing.
Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis

Location Details

NCT05825105

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Locations

RECRUITING

Argentina, Entre Ríos Province

Institute for Research and Development in Bioengineering and Bioinformatics (IBB-CONICET-UNER)

Green gold, Entre Ríos Province, Argentina, 3100