NCT03138317

Evaluation of Platelet Rich Plasma (PRP) for Knee Osteoarthritis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	PRP	This group will receive a knee injection with 6 ml of platelet rich plasma (PRP)
BIOLOGICAL	Plasma	This group will receive a knee injection with 6 ml of plasma.
BIOLOGICAL	Placebo	This group will receive a knee injection with 6 ml saline solution.

Timeline

• Start date: 2017-01-02
• Primary completion: 2018-05-30
• Completion: 2018-05-30
• First posted: 2017-05-03
• Last updated: 2017-05-11

Locations

1 site across 1 country: Brazil