Osteoarthritis, KneePhase 2NCT03138317
Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis
A Phase 2 study testing PRP and Plasma in people with Osteoarthritis, Knee, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Study was designed to evaluate efficacy of autologous platelet rich plasma (PRP) injections guided by ultrasound for treatment of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- PRP and Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2017to 30 May 2018
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged from 45 to 80 years
- Fulfill criteria for knee osteoarthritis of the ACR - American College of Rheumatology (Altman et al., 1986)
- Radiographic classification 2 or 3 by Kellgren and Lawrence score
- Relate pain in the last week of 3 to 8 points on the Visual Analogue Scale - EVA (Bellamy et al., 1988)
Who cannot join
- Use of analgesics, NSAIDs and myorelaxants less than a week before the start of the study.
- Use of slow-acting drugs in osteoarthritis started less than 8 weeks before the start of the study. For cases that they have been in use for more than 8 weeks, they should be maintained until the end of the week.
- Infiltration of corticosteroid or infiltration with hyaluronic acid in the six months prior to the start of the study.
- Intra-articular infiltration with any medication in any other joint less than 1 month after inclusion;
- Introduction of any medical or physiotherapeutic intervention in the last 3 months (rehabilitation, acupuncture, cane, orthotics, etc.) for locomotor system;
- Body Mass Index (BMI) greater than 35.
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- Presence of other types of arthropathies such as rheumatoid arthritis, diffuse connective tissue diseases, microcrystalline arthropathies, spondyloarthropathies and infectious arthropathies.
- Symptomatic osteoarthritis of hip and feet
- Presence of known meniscal or symptomatic ligament damage in the studied knee;
- Previous surgery in the studied knee.
- Difference in length in lower limbs greater than 1 cm.
- Presence of cutaneous lesion on the surface of the joint studied;
- Important scoliosis.
- Blood dyscrasia or use of anticoagulant;
- Presence of other diseases: severe depression, diabetes, coagulopathies, decompensated cardiovascular disease, infection, immunosuppression (allowed MTX up to 10 mg), systemic infectious disease, symptomatic lower limb vascular disease, neurological diseases, neoplasia or any other conditions that may compromise the procedure in doctor evaluation;
- To be receiving pension benefit due to osteoarthritis of the knees.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of São Paulo
São Paulo, São Paulo, 05403000
Ricardo Fuller, PhD, + 55 (11) 26616105., fuller@uol.com.br
About this study
Study was designed to evaluate efficacy of autologous platelet rich plasma (PRP) injections guided by ultrasound for treatment of knee osteoarthritis.
Read the detailed description
Osteoarthritis (OA) is the most prevalent rheumatic disease in the world and its treatment is still relatively limited. The efficacy of platelet rich plasma (PRP) for treatment of osteoarthritis of knees has been demonstrated both in vitro and in vivo. Numerous studies published in literature show a good potential of PRP in treatment of osteoarthritis. However, results are not yet consistent due to methodological gaps such as lack of control, inadequate controls, inadequate assessment tools, inadequate matching for interventions, insufficient description of design and way of obtaining PRP.
The aim of the study is to evaluate efficacy of autologous PRP injections guided by ultrasound for treatment of knee osteoarthritis.
Patients will be randomized into three groups for ultrasound guided knee infiltrations: the first group will receive PRP, the second group will receive plasma and the third group will receive a placebo of physiological solution. All patients will be assessed using Visual Analog Pain Scale, WOMAC (Western Ontario McMasters University Osteoarthritis Index), Knee Injury and Osteoarthritis Outcome Score, conventional radiography, ultrasonography, and follow the standardization of results for clinical trials in Osteoarthritis (OMERACT-OARSI). Patients will be evaluated during clinical follow-up after 1, 4, 12 and 24 weeks.
- Conditions
- Osteoarthritis, Knee
- Being tested
- PRP, Plasma, Placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
This group will receive a knee injection with 6 ml of platelet rich plasma (PRP)
PlasmaBiological
This group will receive a knee injection with 6 ml of plasma.
PlaceboBiological
This group will receive a knee injection with 6 ml saline solution.
| Study group | Role | What they receive |
|---|---|---|
| PRP | Experimental | Goup 1: knee injection of Platelet Rich Plasma (PRP) Receives: Biological: PRP |
| Plasma | Experimental | Group 2: knee injection of Plasma Receives: Biological: Plasma |
| Placebo | Placebo comparator | Group 3: knee injection of placebo (saline solution) Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee pain score measured by Visual Analogue Scale (VAS)
Knee pain score measured by Visual Analogue Scale (VAS)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start2 Jan 2017
- Primary completion30 May 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- RDO Laboratory
- Responsible party
- Principal investigator, Ricardo Fuller, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138317
- Sponsor's protocol ID
- 2
- Status last verified
- Apr 2017
- First submitted
- 16 Apr 2017
- Last updated
- 11 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dorio M, Pereira RMR, Luz AGB, Deveza LA, de Oliveira RM, Fuller R. Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. BMC Musculoskelet Disord. 2021 Sep 24;22(1):822. doi: 10.1186/s12891-021-04706-7.
PubMed 34560869
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03138317
- Acronym / sponsor ID
- 2
- Conditions
- Osteoarthritis, Knee
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- RDO Laboratory
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 30 May 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 3 May 2017 (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.
Study was designed to evaluate efficacy of autologous platelet rich plasma (PRP) injections guided by ultrasound for treatment of knee osteoarthritis.
Detailed description
Osteoarthritis (OA) is the most prevalent rheumatic disease in the world and its treatment is still relatively limited. The efficacy of platelet rich plasma (PRP) for treatment of osteoarthritis of knees has been demonstrated both in vitro and in vivo. Numerous studies published in literature show a good potential of PRP in treatment of osteoarthritis. However, results are not yet consistent due to methodological gaps such as lack of control, inadequate controls, inadequate assessment tools, inadequate matching for interventions, insufficient description of design and way of obtaining PRP.
The aim of the study is to evaluate efficacy of autologous PRP injections guided by ultrasound for treatment of knee osteoarthritis.
Patients will be randomized into three groups for ultrasound guided knee infiltrations: the first group will receive PRP, the second group will receive plasma and the third group will receive a placebo of physiological solution. All patients will be assessed using Visual Analog Pain Scale, WOMAC (Western Ontario McMasters University Osteoarthritis Index), Knee Injury and Osteoarthritis Outcome Score, conventional radiography, ultrasonography, and follow the standardization of results for clinical trials in Osteoarthritis (OMERACT-OARSI). Patients will be evaluated during clinical follow-up after 1, 4, 12 and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PRP | Experimental | Biological: PRPGoup 1: knee injection of Platelet Rich Plasma (PRP) |
| Plasma | Experimental | Biological: PlasmaGroup 2: knee injection of Plasma |
| Placebo | Placebo comparator | Biological: PlaceboGroup 3: knee injection of placebo (saline solution) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women aged from 45 to 80 years
- Fulfill criteria for knee osteoarthritis of the ACR - American College of Rheumatology (Altman et al., 1986)
- Radiographic classification 2 or 3 by Kellgren and Lawrence score
- Relate pain in the last week of 3 to 8 points on the Visual Analogue Scale - EVA (Bellamy et al., 1988)
Key exclusion criteria (16 listed)
- Use of analgesics, NSAIDs and myorelaxants less than a week before the start of the study.
- Use of slow-acting drugs in osteoarthritis started less than 8 weeks before the start of the study. For cases that they have been in use for more than 8 weeks, they should be maintained until the end of the week.
- Infiltration of corticosteroid or infiltration with hyaluronic acid in the six months prior to the start of the study.
- Intra-articular infiltration with any medication in any other joint less than 1 month after inclusion;
- Introduction of any medical or physiotherapeutic intervention in the last 3 months (rehabilitation, acupuncture, cane, orthotics, etc.) for locomotor system;
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 |
|---|---|---|
| PRPThis group will receive a knee injection with 6 ml of platelet rich plasma (PRP) | Biological | PRP |
| PlasmaThis group will receive a knee injection with 6 ml of plasma. | Biological | Plasma |
| PlaceboThis group will receive a knee injection with 6 ml saline solution. | Biological | Placebo |
Primary outcome
Knee pain score measured by Visual Analogue Scale (VAS)
Time frame: 24 weeks
Knee pain score measured by Visual Analogue Scale (VAS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Derived from this study: PubMed 34560869Dorio M, Pereira RMR, Luz AGB, Deveza LA, de Oliveira RM, Fuller R. Efficacy of platelet-rich plasma and plasma for symptomatic treatment of knee osteoarthritis: a double-blinded placebo-controlled randomized clinical trial. BMC Musculoskelet Disord. 2021 Sep 24;22(1):822. doi: 10.1186/s12891-021-04706-7.
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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.
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 PRP and Plasma in people with Osteoarthritis, Knee, run by University of Sao 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 4 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 May 2017. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Fuller, PhD (+55 (11) 26616105., fuller@uol.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee pain score measured by Visual Analogue Scale (VAS) (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03138317, which also lists 1 linked publication.
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 11 May 2017.