Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
Recruiting · NCT06483269 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- IRCCS - Istituto ortopedico Rizzoli - Bologna, Italy