NCT02448407

Intraarticular Injections of Platelet-rich Plasma in Pain's Treatment of the Osteoarthritic Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Platelet-rich plasma (PRP), due to its high content of cytokines, bioactive proteins and platelet growth factors, may contribute to diminish the pain of arthritic knee. It was also recently recognized a regenerative cell potential improving the concentration of hyaluronic acid and stabilizing angiogenesis in arthritic knees This study therefore seeks to assess the analgesic power of PRP in osteoarthritic knees intraarticularly infiltrated, and which patients would benefit most from treatment, eliminating false expectations in the rest.

Detailed description

This is the first clinical trial developed following the report of the Spanish Competent Authority on May 23, 2013, considering the PRP as a medicinal product for human use and establishing minimum guarantees required of the product and the process of manufacturing. It has been conducted from the perspective of both the trauma and the specialized treatment of chronic pain anesthesiologist, and manufacturing the PRP on the premises of a Regional Centre for Transfusions, all belonging to the Public Health System and therefore without commercial interests.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
BIOLOGICAL	Platelet rich plasma	Three intraarticular injections of platelet-rich plasma, one each fifteen days
DRUG	Hyaluronic acid	Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-06-01
• Completion: 2014-11-01
• First posted: 2015-05-19
• Last updated: 2015-05-19