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
Study was designed to evaluate efficacy of autologous platelet rich plasma (PRP) injections guided by ultrasound for treatment of knee osteoarthritis.
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.
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 →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.
Exclusion Criteria:
Goup 1: knee injection of Platelet Rich Plasma (PRP)
Biological: PRP
Group 2: knee injection of Plasma
Biological: Plasma
Group 3: knee injection of placebo (saline solution)
Biological: Placebo
This group will receive a knee injection with 6 ml of platelet rich plasma (PRP)
This group will receive a knee injection with 6 ml of plasma.
This group will receive a knee injection with 6 ml saline solution.
Knee pain score measured by Visual Analogue Scale (VAS)
Knee pain score measured by Visual Analogue Scale (VAS)
Time frame: 24 weeks
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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University of Sao Paulo