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Clinical Trial Summary

The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.


Clinical Trial Description

204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04901273
Study type Interventional
Source Istituto Ortopedico Rizzoli
Contact Roberta Licciardi, Msc
Phone 0516366567
Email roberta.licciardi@ior.it
Status Recruiting
Phase N/A
Start date December 15, 2021
Completion date June 2025

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