Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis

NCT05825105 | Active Not Recruiting Phase 2 DMC

• 2 other identifiers: PRP-BXD1IS004027
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

Keywords

Autologous Treatments; Public Health; Lower Extremity; Argentina; Real-world studies

Outcome Measures

Primary Outcomes (1)

• Change in the Western Ontario and McMaster Universities (WOMAC) Ostearthritis Index

  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 Outcomes (5)

• Change in the the Lower Extremity Functional Scale (LEFS) Index

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

• Change in Maximum Voluntary Isometric Contraction (MVIC) strength of the quadriceps

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

• Centre of pressure (COP) on the plantar surface of the foot

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

• Timed Up and Go (TUG) Test

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

• Five Times Sit to Stand (FTSTS) Test

  Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.

Study Arms (2)

PRP-1

EXPERIMENTAL

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

Biological: Platelet-Rich Plasma

PRP-2

ACTIVE COMPARATOR

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

Biological: Platelet-Rich Plasma

Interventions

Platelet-Rich Plasma 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-1; PRP-2

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Radiological diagnosis of knee OA
• Age over 35 years old
• WOMAC value of 24 or higher at the time of recruitment

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Nacional de Entre Rios: lead
• National Council of Scientific and Technical Research, Argentina: collaborator

Study Sites (1)

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

Oro Verde, Entre Ríos Province, 3100, Argentina

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Luis P Schierloh, Doctor

  National Council of Scientific and Technical Research, Argentina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Investigator

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 24, 2023
• Study Start: May 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

AR (1)