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Clinical Trials in Italy / NCT06483269
Recruiting Not applicable

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

NCT06483269 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Not applicable
Started
2023-10-10
Last updated
2025-07-04

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

PRP infiltration

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
40 Years
Healthy volunteers
No
Inclusion Criteria: * Patients, both sexes, with symptomatic knee osteoarthritis with: * Age: 18-40 years; * Unilateral involvement; * Signs and symptoms of knee osteoarthritis; * Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3); * Ability and consent of patients to actively participate in clinical follow-up; * Signature of informed consent; * Pain ≥ 4 on VAS s Exclusion Criteria: * Patients unable to express consent; * Patients undergoing intra-articular infiltration of other substance in the previous 6 months; * Patients undergoing knee surgery in the previous 12 months; * Patients with malignant neoplasms; * Patients with rheumatic diseases; * Patients with uncontrolled metabolic diseases; * Patients with hematological diseases (coagulopathies); * Patients abusing alcoholic beverages, drugs or medications; * Knee trauma treated in the previous 6 months. * Other conditions that may interfere with the evaluation of OA treatment.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
IRCCS - Istituto ortopedico Rizzoli Bologna Italy Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06483269 on ClinicalTrials.gov ↗ ← All trials in Italy