Knee OsteoarthritisPhase 2NCT05825105
Effectiveness of Platelet-rich Plasma Treatment of Knee Osteoarthritis
A Phase 2 study testing Platelet-Rich Plasma in people with Knee Osteoarthritis, run by Universidad Nacional de Entre Rios at 1 site in Argentina.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Platelet-Rich Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteArgentina
- Study dates
- 1 May 2024to 10 Sep 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiological diagnosis of knee OA
- Age over 35 years old
- WOMAC value of 24 or higher at the time of recruitment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Argentina1 site
Institute for Research and Development in Bioengineering and Bioinformatics (IBB-CONICET-UNER)
Oro Verde, Entre Ríos Province, 3100
About this study
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
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
- Being tested
- Platelet-Rich Plasma
- Keywords
- Autologous Treatments, Public Health, Lower Extremity, Argentina, Real-world studies
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich PlasmaBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| PRP-1 | Experimental | Platelet-rich plasma, short treatment (three sessions every two weeks) Receives: Biological: Platelet-Rich Plasma |
| PRP-2 | Active comparator | Platelet-rich plasma, long treatment (three sessions every four weeks) Receives: Biological: Platelet-Rich Plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Change in Maximum Voluntary Isometric Contraction (MVIC) strength of the quadriceps
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Centre of pressure (COP) on the plantar surface of the foot
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Timed Up and Go (TUG) Test
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Five Times Sit to Stand (FTSTS) Test
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.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 24 weeks, 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 May 2024
- Primary completion20 Aug 2026
- Study completion10 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Nacional de Entre Rios
- Sponsor type
- University, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina
- Responsible party
- Principal investigator, Pablo Schierloh, Universidad Nacional de Entre Rios
- Investigators
- Luis P Schierloh, Doctor, Principal investigator, National Council of Scientific and Technical Research, Argentina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825105
- Sponsor's protocol ID
- PRP-BXD1
- Other IDs
- IS004027
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05825105
- Acronym / sponsor ID
- PRP-BXD1
- Conditions
- Knee Osteoarthritis
- Keywords
- Autologous Treatments, Public Health, Lower Extremity, Argentina, Real-world studies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Universidad Nacional de Entre RiosUniversity, hospital or other
- Collaborators
- National Council of Scientific and Technical Research, Argentina
- Study start
- 1 May 2024 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRP-1 | Experimental | Biological: Platelet-Rich PlasmaPlatelet-rich plasma, short treatment (three sessions every two weeks) |
| PRP-2 | Active comparator | Biological: Platelet-Rich PlasmaPlatelet-rich plasma, long treatment (three sessions every four weeks) |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Radiological diagnosis of knee OA
- Age over 35 years old
- WOMAC value of 24 or higher at the time of recruitment
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platelet-Rich PlasmaThe 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. | Biological | PRP-1, PRP-2 |
Primary outcome
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.
5 secondary outcomes
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.
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.
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.
Timed Up and Go (TUG) Test
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis P Schierloh, Doctor principal investigator
National Council of Scientific and Technical Research, Argentina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Platelet-Rich Plasma in people with Knee Osteoarthritis, run by Universidad Nacional de Entre Rios at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.