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Status unknownNCT03138317Updated May 11, 2017

Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

A Phase 2 interventional study of PRP and Plasma in Osteoarthritis, Knee, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-05-11.

Sponsored by University of Sao Paulo · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2017), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jan 2017, registered Apr 2017).
Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 80 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Men and women aged from 45 to 80 years
  2. Fulfill criteria for knee osteoarthritis of the ACR - American College of Rheumatology (Altman et al., 1986)
  3. Radiographic classification 2 or 3 by Kellgren and Lawrence score
  4. Relate pain in the last week of 3 to 8 points on the Visual Analogue Scale - EVA (Bellamy et al., 1988)

Exclusion criteria

Exclusion Criteria:

  1. Use of analgesics, NSAIDs and myorelaxants less than a week before the start of the study.
  2. 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.
  3. Infiltration of corticosteroid or infiltration with hyaluronic acid in the six months prior to the start of the study.
  4. Intra-articular infiltration with any medication in any other joint less than 1 month after inclusion;
  5. Introduction of any medical or physiotherapeutic intervention in the last 3 months (rehabilitation, acupuncture, cane, orthotics, etc.) for locomotor system;
  6. Body Mass Index (BMI) greater than 35.
  7. Presence of other types of arthropathies such as rheumatoid arthritis, diffuse connective tissue diseases, microcrystalline arthropathies, spondyloarthropathies and infectious arthropathies.
  8. Symptomatic osteoarthritis of hip and feet
  9. Presence of known meniscal or symptomatic ligament damage in the studied knee;
  10. Previous surgery in the studied knee.
  11. Difference in length in lower limbs greater than 1 cm.
  12. Presence of cutaneous lesion on the surface of the joint studied;
  13. Important scoliosis.
  14. Blood dyscrasia or use of anticoagulant;
  15. 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;
  16. To be receiving pension benefit due to osteoarthritis of the knees.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    PRP

    Goup 1: knee injection of Platelet Rich Plasma (PRP)

    Biological: PRP

  • Experimental
    Plasma

    Group 2: knee injection of Plasma

    Biological: Plasma

  • Placebo comparator
    Placebo

    Group 3: knee injection of placebo (saline solution)

    Biological: Placebo

Interventions

  • BiologicalPRP

    This group will receive a knee injection with 6 ml of platelet rich plasma (PRP)

  • BiologicalPlasma

    This group will receive a knee injection with 6 ml of plasma.

  • BiologicalPlacebo

    This group will receive a knee injection with 6 ml saline solution.

06

What researchers measure

Primary outcomes

  1. Knee pain score measured by Visual Analogue Scale (VAS)

    Knee pain score measured by Visual Analogue Scale (VAS)

    Time frame: 24 weeks

07

Study locations

1 of 1 sites recruiting
  • University of São Paulo
    Sao Paulo, SP 05403000, Brazil
    Recruiting
08

References and documents

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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03138317
Lead sponsor
University of Sao Paulo
Collaborators
RDO Laboratory
Responsible party
Ricardo Fuller (Assistant of Osteoarthritis ambulatory; PhD researcher., University of Sao Paulo) — Principal investigator
First posted
May 3, 2017
Start date
Jan 2, 2017
Primary completion
May 30, 2018 (estimated)
Completion
May 30, 2018 (estimated)
Last update
May 11, 2017

Study contacts

Ricardo Fuller, PhD
Contact
fuller@uol.com.br
+55 (11) 26616105.

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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