Gonarthrosis; PrimaryPhase 4iPRFNCT06905860
Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis
A Phase 4 study testing Platelet-rich fibrin (PRF) and Corticosteroid in people with Gonarthrosis; Primary, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
Methodology: Randomized double-blind clinical trial comparing intra-articular injection of Platelet-Rich Fibrin (PRF) versus intra-articular injection of corticosteroids in mild to moderate arthrosis of the knee. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gonarthrosis; Primary
- What is being tested?
- Platelet-rich fibrin (PRF) and Corticosteroid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2025to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -Absence from work due to disability benefits or income reduction assistance (worker's compensation). Whenever one of the investigators believes that a participant may be simulating a worse health condition than reality to receive financial assistance with work absence, they will be excluded from the study.
- The following non-inclusion criteria will be observed:
- Angular deviation >10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane assessed clinically with a goniometer (anatomical axis of the femur x anatomical axis of the tibia > 4º varus or > 16º valgus)
- Body Mass Index (BMI)>35 or <18
- Smoking
- Autoimmune inflammatory disease - rheumatological
Show all 18Show fewer
- Diabetes - with HbA1c > 7
- Chronic kidney disease
- Coagulopathies
- severe cardiovascular diseases
- infections or immunodeficiencies
- active or treated malignant neoplasia
- use of NSAIDs in the last month
- use of corticosteroids in the last 3 months
- platelets < 150,000
- recent intra-articular corticosteroid injection or recent HA injection (in the last 6 months)
- pregnancy or suspected pregnancy
- psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Universidade Federal de São Paulo
São Paulo, São Paulo, 04023-062
Rodrigo A Mastrorosa, DR, +55 11 971105634, rodrigoamastrorosa@gmail.com
RODRIGO DE ALMEIDA MASTROROSA, DR
About this study
Methodology: Randomized double-blind clinical trial comparing intra-articular injection of Platelet-Rich Fibrin (PRF) versus intra-articular injection of corticosteroids in mild to moderate arthrosis of the knee. Inclusion criteria: Age 50 years or older, who have not improved with non-surgical treatment for at least 3 months, ability to sign informed consent, mean visual analogue scale > 40/100 (over at least 7 days during the month anterior), mild or moderate knee arthrosis diagnosed by grade 2 or 3 radiographic imaging according to the Kellgren-Lawrence classification. Inclusion criteria: angular deviation >10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane clinically evaluated with a goniometer (femur anatomical axis x tibial anatomical axis > 4th varus or > 16th valgus), BMI >35 or <18, smoking , autoimmune inflammatory disease - rheumatologic, diabetes - with glycated Hb > 7, chronic kidney disease, coagulopathies, severe cardiovascular diseases, infections or immunodeficiencies, malignant neoplasm in activity or under treatment, use of NSAIDs in the last month, use of corticosteroids in the last 3 months, platelets < 150,000, recent intra-articular corticosteroid infiltration or recent Hyaluronic acid infiltration (within the last 6 months), pregnancy or suspected pregnancy, psychiatric disorders. Exclusion criteria: when one of the investigators considers that the participant may be simulating a worse health state than the real one in order to receive financial assistance with the absence from work, he will be excluded from the work. Primary outcome: WOMAC. Secondary outcomes: Visual Analogue Pain Scale. Evaluation moments: inclusion and after the procedure at 3, 6, 12, 18 and 24 months. Sample calculation: 90 patients, 45 patients in each group, considering 15% loss to follow-up and aiming to reach a power of 0.8 and an alpha value of 0.5.
Read the detailed description
The objective of this work is to compare the efficacy of intra-articular injection of PRF versus intra-articular application of corticosteroid in the treatment of patients with mild to moderate knee osteoarthritis This study will be a prospective, randomized, double-blind, comparative clinical trial with a 1:1 allocation ratio following the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Patients with knee osteoarthritis will be screened at the Knee Outpatient Clinic of the Department of Orthopedics and Traumatology of EPM-UNIFESP.
The Intervention Group consists of intra-articular application of PRF in the knee, while the Control Group consists of intra-articular application of corticosteroids in the knee. For patients in both groups (PRF or corticosteroid), 40ml of venous blood will be collected for the preparation of PRF, and the infiltration will be performed or not, according to random allocation. For patients in the corticosteroid group, the blood sample will be discarded.
The Intervention Group consists of intra-articular application of PRF in the knee. The applications will be performed by the same physician. Patients will be blinded to ensure they do not know which group each individual belongs to. Three applications of PRF will be carried out with intervals of 14 to 28 days between them.
A total of 10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same physical therapy and rehabilitation protocol. There will be no restrictions on weight-bearing or range of motion in the knee during the application. As a rescue medication for pain, if VAS > 3, patients may use Paracetamol 750mg every 6 hours per day and/or Dipyrone up to 1g every 6 hours per day. If they experience VAS > 7, they may use Tramadol 100mg every 6 hours, with all medications being monitored.
The procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient).
In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 3ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. As rescue medication for pain, if the Visual Analog Scale (VAS) score is greater than 3, patients may use Paracetamol 750mg every 6 hours per day and/or Dipyrone up to 1g every 6 hours per day. If they have a VAS score greater than 7, they may use Tramadol 100mg every 6 hours, with all medications being monitored.
The assessments will include the Visual Analog Scale for Pain and the WOMAC questionnaire. The primary outcome will be the WOMAC (Pain subscale). The average time to complete these questionnaires is 10 minutes. All outcomes will be assessed at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months. All patients will also be evaluated 2 weeks after the procedure to investigate possible complications. Additionally, evaluations of other secondary outcomes such as physiotherapy participation, amount of analgesic use, and knee range of motion will be conducted.
The questionnaires will be sent and answered by patients electronically, and the analyses will be carried out by a statistician. Patients and statisticians performing the assessments and analyses will be blinded to each task so that they do not know to which group each individual belongs.
A clinical failure will be considered if a patient's pain is greater than or equal to the pain they experienced before the interventions, occurring more than 50% of the days in the last month or assessment period (the period between evaluations). These failures will be reported as efficacy over 6 months, 1 year, and 2 years. Based on these results, the patient may undergo another treatment (which could be the same treatment they previously received or not).
- Conditions
- Gonarthrosis; Primary
- Being tested
- Platelet-rich fibrin (PRF), Corticosteroid
- Keywords
- gonarthrosis, i-PRF
- 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 fibrin (PRF)Drug
The Intervention Group consists of the intra-articular application of PRF in the knee. The applications will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. A total of 3 applications of PRF will be conducted, with intervals of 14 to 28 days between them.
10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated.
CorticosteroidDrug
Also called corticoid
The procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient).
In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 10ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated.
| Study group | Role | What they receive |
|---|---|---|
| Corticoid | Active comparator | The procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient).
In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 10ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. Receives: Drug: Corticosteroid |
| platelet-rich fibrin | Experimental | The Intervention Group consists of the intra-articular application of PRF in the knee. The applications will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. A total of 3 applications of PRF will be conducted, with intervals of 14 to 28 days between them.
10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. Receives: Drug: Platelet-rich fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
The following will be assessed: Western Ontario and McMaster Universities Arthritis Index (WOMAC) 0-100. The primary outcome will be WOMAC Pain subscale. The average time to complete these questionnaires is 10 minutes. All outcomes will be evaluated at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months. All patients will also be evaluated 2 weeks after the procedure to investigate possible complications.
Measured: All outcomes will be evaluated at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gonarthrosis; PrimaryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double-blind clinical trial comparing intra-articular injection of PRF versus intra-articular injection of corticosteroids in mild to moderate arthrosis of the knee. Inclusion criteria: Age 50 years or older, who have not improved with non-surgical treatment for at least 3 months, ability to sign informed consent, mean visual analogue scale \> 40/100 (over at least 7 days during the month anterior), mild or moderate knee arthrosis diagnosed by grade 2 or 3 radiographic imaging according to the Kellgren-Lawrence classification. Inclusion criteria: angular deviation \>10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane clinically evaluated with a goniometer (femur anatomical axis x tibial anatomical axis \> 4th varus or \> 16th valgus), BMI \>35 or \<18, smoking , autoimmune inflammatory disease - rheumatologic, diabetes - with glycated Hb \> 7, chronic kidney disease, coagulopathies, severe cardiovascular diseases, infections or immunodeficiencies,
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo de Almeida Mastrorosa, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905860
- Sponsor's protocol ID
- 75935723.4.0000.5505
- Acronym
- iPRF
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing is essential for scientific transparency, study reproducibility, and the advancement of knowledge. However, it is crucial to protect participants' privacy, especially when the data contains sensitive information. The study data will be submitted for publication in a scientific journal after anonymization Regarding the data, its handling, treatment, protection, confidentiality, and transparency, the Data Management Plan Tool - DMPTOOL (https://dmptool.org/) will be used, with institutional identification from UNIFESP. One of the researchers involved will access DMPTOOL through their UNIFESP institutional email to create the data management plan for this project, which will be submitted to the UNIFESP Dataverse research data repository (https://repositoriodedados.unifesp.br).
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Infiltration of Platelet-Rich Fibrin vs Corticosteroid in Mild to Moderate Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06905860
- Acronym / sponsor ID
- iPRF / 75935723.4.0000.5505
- Conditions
- Gonarthrosis; Primary
- Keywords
- gonarthrosis, i-PRF
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 2 Apr 2025 (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.
Methodology: Randomized double-blind clinical trial comparing intra-articular injection of Platelet-Rich Fibrin (PRF) versus intra-articular injection of corticosteroids in mild to moderate arthrosis of the knee. Inclusion criteria: Age 50 years or older, who have not improved with non-surgical treatment for at least 3 months, ability to sign informed consent, mean visual analogue scale > 40/100 (over at least 7 days during the month anterior), mild or moderate knee arthrosis diagnosed by grade 2 or 3 radiographic imaging according to the Kellgren-Lawrence classification. Inclusion criteria: angular deviation >10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane clinically evaluated with a goniometer (femur anatomical axis x tibial anatomical axis > 4th varus or > 16th valgus), BMI >35 or <18, smoking , autoimmune inflammatory disease - rheumatologic, diabetes - with glycated Hb > 7, chronic kidney disease, coagulopathies, severe cardiovascular diseases, infections or immunodeficiencies, malignant neoplasm in activity or under treatment, use of NSAIDs in the last month, use of corticosteroids in the last 3 months, platelets < 150,000, recent intra-articular corticosteroid infiltration or recent Hyaluronic acid infiltration (within the last 6 months), pregnancy or suspected pregnancy, psychiatric disorders. Exclusion criteria: when one of the investigators considers that the participant may be simulating a worse health state than the real one in order to receive financial assistance with the absence from work, he will be excluded from the work. Primary outcome: WOMAC. Secondary outcomes: Visual Analogue Pain Scale. Evaluation moments: inclusion and after the procedure at 3, 6, 12, 18 and 24 months. Sample calculation: 90 patients, 45 patients in each group, considering 15% loss to follow-up and aiming to reach a power of 0.8 and an alpha value of 0.5.
Detailed description
The objective of this work is to compare the efficacy of intra-articular injection of PRF versus intra-articular application of corticosteroid in the treatment of patients with mild to moderate knee osteoarthritis This study will be a prospective, randomized, double-blind, comparative clinical trial with a 1:1 allocation ratio following the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Patients with knee osteoarthritis will be screened at the Knee Outpatient Clinic of the Department of Orthopedics and Traumatology of EPM-UNIFESP.
The Intervention Group consists of intra-articular application of PRF in the knee, while the Control Group consists of intra-articular application of corticosteroids in the knee. For patients in both groups (PRF or corticosteroid), 40ml of venous blood will be collected for the preparation of PRF, and the infiltration will be performed or not, according to random allocation. For patients in the corticosteroid group, the blood sample will be discarded.
The Intervention Group consists of intra-articular application of PRF in the knee. The applications will be performed by the same physician. Patients will be blinded to ensure they do not know which group each individual belongs to. Three applications of PRF will be carried out with intervals of 14 to 28 days between them.
A total of 10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same physical therapy and rehabilitation protocol. There will be no restrictions on weight-bearing or range of motion in the knee during the application. As a rescue medication for pain, if VAS > 3, patients may use Paracetamol 750mg every 6 hours per day and/or Dipyrone up to 1g every 6 hours per day. If they experience VAS > 7, they may use Tramadol 100mg every 6 hours, with all medications being monitored.
The procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient).
In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 3ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. As rescue medication for pain, if the Visual Analog Scale (VAS) score is greater than 3, patients may use Paracetamol 750mg every 6 hours per day and/or Dipyrone up to 1g every 6 hours per day. If they have a VAS score greater than 7, they may use Tramadol 100mg every 6 hours, with all medications being monitored.
The assessments will include the Visual Analog Scale for Pain and the WOMAC questionnaire. The primary outcome will be the WOMAC (Pain subscale). The average time to complete these questionnaires is 10 minutes. All outcomes will be assessed at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months. All patients will also be evaluated 2 weeks after the procedure to investigate possible complications. Additionally, evaluations of other secondary outcomes such as physiotherapy participation, amount of analgesic use, and knee range of motion will be conducted.
The questionnaires will be sent and answered by patients electronically, and the analyses will be carried out by a statistician. Patients and statisticians performing the assessments and analyses will be blinded to each task so that they do not know to which group each individual belongs.
A clinical failure will be considered if a patient's pain is greater than or equal to the pain they experienced before the interventions, occurring more than 50% of the days in the last month or assessment period (the period between evaluations). These failures will be reported as efficacy over 6 months, 1 year, and 2 years. Based on these results, the patient may undergo another treatment (which could be the same treatment they previously received or not).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized double-blind clinical trial comparing intra-articular injection of PRF versus intra-articular injection of corticosteroids in mild to moderate arthrosis of the knee. Inclusion criteria: Age 50 years or older, who have not improved with non-surgical treatment for at least 3 months, ability to sign informed consent, mean visual analogue scale > 40/100 (over at least 7 days during the month anterior), mild or moderate knee arthrosis diagnosed by grade 2 or 3 radiographic imaging according to the Kellgren-Lawrence classification. Inclusion criteria: angular deviation >10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane clinically evaluated with a goniometer (femur anatomical axis x tibial anatomical axis > 4th varus or > 16th valgus), BMI >35 or <18, smoking , autoimmune inflammatory disease - rheumatologic, diabetes - with glycated Hb > 7, chronic kidney disease, coagulopathies, severe cardiovascular diseases, infections or immunodeficiencies,
| Arm | Type | Receives |
|---|---|---|
| Corticoid | Active comparator | Drug: CorticosteroidThe procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient). In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 10ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. |
| platelet-rich fibrin | Experimental | Drug: Platelet-rich fibrin (PRF)The Intervention Group consists of the intra-articular application of PRF in the knee. The applications will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. A total of 3 applications of PRF will be conducted, with intervals of 14 to 28 days between them. 10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (18 listed)
- -Absence from work due to disability benefits or income reduction assistance (worker's compensation). Whenever one of the investigators believes that a participant may be simulating a worse health condition than reality to receive financial assistance with work absence, they will be excluded from the study.
- Angular deviation >10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane assessed clinically with a goniometer (anatomical axis of the femur x anatomical axis of the tibia > 4º varus or > 16º valgus)
- Body Mass Index (BMI)>35 or <18
- Smoking
- Autoimmune inflammatory disease - rheumatological
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 fibrin (PRF)The Intervention Group consists of the intra-articular application of PRF in the knee. The applications will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. A total of 3 applications of PRF will be conducted, with intervals of 14 to 28 days between them. 10ml of PRF will be applied intra-articularly, on an outpatient basis, with patients being instructed to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. | Drug | platelet-rich fibrin |
| CorticosteroidAlso: corticoidThe procedures will be performed by the same doctor. The patients will be blinded so that they do not know to which group each individual belongs. In this group, 40ml of peripheral blood will also be collected and placed for centrifugation. During the preparation for the application, a nurse (who will not participate in the study) will have a list of the randomization and will prepare the material in an opaque syringe (blinding both the applicator and the patient). In this group of patients, a solution of 10ml containing 40mg of Triamcinolone will be administered in the first application and 10ml of saline in the second and third applications, with intervals of 14 to 28 days between the applications. The applications will be performed on an outpatient basis, with patients being advised to follow the same protocol for physiotherapy and rehabilitation. There will be no restrictions on load or range of motion in the knee being treated. | Drug | Corticoid |
Primary outcome
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Time frame: All outcomes will be evaluated at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months
The following will be assessed: Western Ontario and McMaster Universities Arthritis Index (WOMAC) 0-100. The primary outcome will be WOMAC Pain subscale. The average time to complete these questionnaires is 10 minutes. All outcomes will be evaluated at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months. All patients will also be evaluated 2 weeks after the procedure to investigate possible complications.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Yes. Data sharing is essential for scientific transparency, study reproducibility, and the advancement of knowledge. However, it is crucial to protect participants' privacy, especially when the data contains sensitive information. The study data will be submitted for publication in a scientific journal after anonymization Regarding the data, its handling, treatment, protection, confidentiality, and transparency, the Data Management Plan Tool - DMPTOOL (https://dmptool.org/) will be used, with institutional identification from UNIFESP. One of the researchers involved will access DMPTOOL through their UNIFESP institutional email to create the data management plan for this project, which will be submitted to the UNIFESP Dataverse research data repository (https://repositoriodedados.unifesp.br).
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Platelet-rich fibrin (PRF) and Corticosteroid in people with Gonarthrosis; Primary, run by Federal University of São Paulo at 1 site in Brazil.
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 0 inclusion and 18 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: opening soon, as of the sponsor's last update on 2 Apr 2025. 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 Brazil. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo A Mastrorosa, Dr (+55 11971105634, rodrigoamastrorosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Arthritis Index (WOMAC) (time frame: All outcomes will be evaluated at the time of inclusion in the study and after the procedure at 3 months, 6 months, 12 months, 18 months, and 24 months). 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 2 Apr 2025.