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RECRUITING
NCT05825105
PHASE2

Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis

Sponsor: Universidad Nacional de Entre Rios

View on ClinicalTrials.gov

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.

Official title: Efectividad Del Plasma Rico en Plaquetas (PRP) Para la disminución Objetiva Del Dolor y la recuperación Funcional Del Miembro Inferior en Osteoartritis de Rodilla. Evaluación de Alternativas metodológicas

Key Details

Gender

All

Age Range

35 Years - Any

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2024-05-01

Completion Date

2025-09

Last Updated

2024-05-20

Healthy Volunteers

No

Interventions

BIOLOGICAL

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.

Locations (1)

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

Oro Verde, Entre Ríos Province, Argentina