Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis

NCT ID: NCT05825105

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-09-30

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.

Conditions

Knee Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PRP-1

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

Group Type: EXPERIMENTAL

Platelet-Rich Plasma

Intervention Type: BIOLOGICAL

The PRP will be prepared using a single centrifugation process. Approximately 30 ml of peripheral blood will be drawn and collected into a vacutainer tubes with sodium citrate anticoagulant 0.129 mol/l (3.8%). The tubes will then be centrifuged at 900 RPM for 12 minutes at room temperature in a benchtop centrifuge. We will separate the lower third of the plasma fraction from all tubes with a syringe and needle, taking care to avoid the leukocyte layer. The PRP will be refrigerated at 4°C for no less than 1 hour. We will not use any exogenous factors to stimulate the platelet activation process. The periauricular skin surface will be disinfected with a povidone iodine solution, and an intra-articular local anesthetic with 1% lidocaine will be applied. A 21-gauge needle will be placed at the point of application. Finally, PRP will be injected into the joint, and the needle will be removed.

PRP-2

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

Group Type: ACTIVE_COMPARATOR

Platelet-Rich Plasma

Intervention Type: BIOLOGICAL

The PRP will be prepared using a single centrifugation process. Approximately 30 ml of peripheral blood will be drawn and collected into a vacutainer tubes with sodium citrate anticoagulant 0.129 mol/l (3.8%). The tubes will then be centrifuged at 900 RPM for 12 minutes at room temperature in a benchtop centrifuge. We will separate the lower third of the plasma fraction from all tubes with a syringe and needle, taking care to avoid the leukocyte layer. The PRP will be refrigerated at 4°C for no less than 1 hour. We will not use any exogenous factors to stimulate the platelet activation process. The periauricular skin surface will be disinfected with a povidone iodine solution, and an intra-articular local anesthetic with 1% lidocaine will be applied. A 21-gauge needle will be placed at the point of application. Finally, PRP will be injected into the joint, and the needle will be removed.

Interventions

Platelet-Rich Plasma

The PRP will be prepared using a single centrifugation process. Approximately 30 ml of peripheral blood will be drawn and collected into a vacutainer tubes with sodium citrate anticoagulant 0.129 mol/l (3.8%). The tubes will then be centrifuged at 900 RPM for 12 minutes at room temperature in a benchtop centrifuge. We will separate the lower third of the plasma fraction from all tubes with a syringe and needle, taking care to avoid the leukocyte layer. The PRP will be refrigerated at 4°C for no less than 1 hour. We will not use any exogenous factors to stimulate the platelet activation process. The periauricular skin surface will be disinfected with a povidone iodine solution, and an intra-articular local anesthetic with 1% lidocaine will be applied. A 21-gauge needle will be placed at the point of application. Finally, PRP will be injected into the joint, and the needle will be removed.

Intervention Type: BIOLOGICAL

Eligibility 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.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Council of Scientific and Technical Research, Argentina

OTHER_GOV

Sponsor Role: collaborator

Universidad Nacional de Entre Rios

OTHER

Sponsor Role: lead

Responsible Party

Pablo Schierloh

Associate Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Oro Verde, Entre Ríos Province, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Pablo Schierloh, PhD

Role: CONTACT

pablo.schierloh@uner.edu.ar

+5491131325656

Facundo N Urteaga, PhD Student

Role: CONTACT

facundo.urteaga@uner.edu.ar

+54113425110760

Facility Contacts

Gaston Schlottauer, PhD

Role: primary

gaston.schlotthauer@uner.edu.ar

Other Identifiers

IS004027

Identifier Type: OTHER

Identifier Source: secondary_id

PRP-BXD1

Identifier Type: -

Identifier Source: org_study_id