Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis

Universidad Nacional de Entre Rios

Status and phase: Enrolling; Phase 2

Conditions: Knee Osteoarthritis

Treatments: Biological: Platelet-Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT05825105

PRP-BXD1

IS004027 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 110 estimated patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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110 participants in 2 patient groups

PRP-1

Experimental group

Description:

Platelet-rich plasma, short treatment (three sessions every two weeks)

Treatment:

Biological: Platelet-Rich Plasma

PRP-2

Active Comparator group

Description:

Platelet-rich plasma, long treatment (three sessions every four weeks)

Treatment:

Biological: Platelet-Rich Plasma