NCT06483269

Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The study consists of 3 phases (enrollment, infiltrative procedure, and controls): * Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Signing of informed consent form and completion of evaluation questionnaires. * infiltrative procedure * Patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). Questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. Any adverse events to treatment will also be assessed during follow-up visits. The duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	PRP infiltration	a single intra-articular infiltration of 5 mL of PRP-O will be performed by the infiltrating physician. It is specified that the PRP-O used within the study will be produced following the guidelines and standards for the production of blood products for non-transfusion use as already in place at the Unified Metropolitan Transfusion Service IOR site. PRP (Platelet Rich Plasma) is produced from platelet pool from donor buffy coat. PRP contains 1,000,000 PLT/mml +/- 20%, as required by current regulations.

Timeline

• Start date: 2023-10-10
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2024-07-03
• Last updated: 2025-07-04

Locations

1 site across 1 country: Italy