Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis

September 14, 2026 updated by: Pablo Schierloh, Universidad Nacional de Entre Rios

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

111

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Entre Ríos Province
      • Oro Verde, Entre Ríos Province, Argentina, 3100
        • Institute for Research and Development in Bioengineering and Bioinformatics (IBB-CONICET-UNER)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRP-1
Platelet-rich plasma, short treatment (three sessions every two weeks)
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.
Active Comparator: PRP-2
Platelet-rich plasma, long treatment (three sessions every four weeks)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire assesses the symptoms and physical disability of individuals with OA. The WOMAC consists of multiple-choice questions, and the responses are scored from zero to four. The final score is calculated between 0 and 96, where higher scores correspond to greater pain, stiffness, and lower functionality, indicating worsening symptoms.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the the Lower Extremity Functional Scale (LEFS) Index
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
The Lower Extremity Functional Scale (LEFS) questionnaire is a self-administered questionnaire assessing functional status in patients with various lower limb musculoskeletal conditions, including OA. It consists of 20 items, each scored on a 5-point scale. The maximum possible score is 80, indicating the best functional level.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Change in Maximum Voluntary Isometric Contraction (MVIC) strength of the quadriceps
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
MVIC (maximum voluntary isometric contraction) strength of the quadriceps will be assessed using an instrumented load cell, which measures in kilograms. Objective and reliable assessment of muscle strength is well-supported for monitoring disease progression and evaluating therapeutic interventions. The test will involve asking the patient to extend the knee with maximum possible force for 3 seconds, ensuring that the hip and knee are at 90 degrees. Three repetitions will be performed with 2-minute rests.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Centre of pressure (COP) on the plantar surface of the foot
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
The measurement of plantar pressure pattern and COP will be performed using a foot-X AR-1 pressure platform. The patient will be positioned upright or anatomically on the platform for a period of time during which the application will record the pressure values. The measurement will be bipedal (both feet on the platform), so both an integral COP of both feet and an individual COP of each foot will be obtained.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Timed Up and Go (TUG) Test
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
The FTSTS and TUG tests are reliable and validated clinical tools that are used as predictors of health problems or disability. The first one consists of the time it takes to sit and stand five times in a row. The second one is similar, but adds a walk at a certain distance.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Five Times Sit to Stand (FTSTS) Test
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
The FTSTS and TUG tests are reliable and validated clinical tools that are used as predictors of health problems or disability. The first one consists of the time it takes to sit and stand five times in a row. The second one is similar, but adds a walk at a certain distance.
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Nacional de Entre Rios

Collaborators

National Council of Scientific and Technical Research, Argentina

Investigators

  • Principal Investigator: Luis P Schierloh, Doctor, National Council of Scientific and Technical Research, Argentina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

August 20, 2026

Study Completion (Actual)

September 10, 2026

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

September 15, 2026

Last Update Submitted That Met QC Criteria

September 14, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRP-BXD1
  • IS004027 (Other Identifier: RENIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data (IPD) underlying the results reported in this study will be shared after de-identification. The dataset will include demographic variables (e.g., age, sex), clinical baseline characteristics, intervention details related to platelet-rich plasma (PRP) preparation and administration, and outcome measures assessing pain and functional recovery (e.g., validated clinical scores). No personally identifiable information will be included.

IPD Sharing Time Frame

Data will be available beginning 6 months after publication of the primary results and will remain available for a period of 5 years.

IPD Sharing Access Criteria

Access to the data will be provided to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the study investigators. Data will be shared upon approval of the proposal and after execution of a data use agreement. The data will be used exclusively for scientific and non-commercial purposes, ensuring compliance with ethical standards and participant confidentiality.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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