NCT06483269 Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
| NCT ID | NCT06483269 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-10-10 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2023-10-10 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06483269 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06483269 currently recruiting?
Yes, NCT06483269 is actively recruiting participants. Contact the research team at mirco.lopresti@ior.it for enrollment information.
Where is the NCT06483269 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06483269 clinical trial?
NCT06483269 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 30 participants.