NCT04937998 PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT
| NCT ID | NCT04937998 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Patellofemoral Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 166 participants |
| Start Date | 2022-10-26 |
| 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 166 participants in total. It began in 2022-10-26 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 aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA
Eligibility Criteria
Inclusion Criteria: 1. Age between 30 and 65; 2. Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees; 3. Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. \[PMID: 2302884 - PMID: 27979409\] ; 4. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC exam); 5. No clinically significant electrocardiographic alterations (Recently performed ECG). 6. Ability and consent of patients to actively participate in clinical follow-up; 7. Signature of informed consent. Exclusion Criteria: 1. Patients unable to express consent; 2. Patients who have undergone intra-articular infiltration of another substance within the previous 6 months; 3. Patients undergoing knee surgery within the previous 12 months; 4. Patients with malignant neoplasms; 5. Patients with rheumatic diseases; 6. Patients with diabetes; 7. Patients with hematologic diseases (coagulopathies); 8. Patients on anticoagulant-antiaggregant therapy; 9. Patients with thyroid metabolic disorders; 10. Patients abusing alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35; 12. Patients who have taken NSAIDs in the 3 days prior to blood draw; 13. Patients with cardiovascular disease for which a 60 mL blood draw would be contraindicated; 14. Patients with a recently performed blood test with Hb\< 11 g/dl and Platelets \< 150,000 plt/mm3. 15. Previous treatment of patellar dislocation 16. Iwano score of grade 4.
Contact & Investigator
Alessandro Di Martino, MD
PRINCIPAL INVESTIGATOR
Istituto Ortopedico Rizzoli
Frequently Asked Questions
Who can join the NCT04937998 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 65 Years, studying Patellofemoral Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04937998 currently recruiting?
Yes, NCT04937998 is actively recruiting participants. Contact the research team at roberta.licciardi@ior.it for enrollment information.
Where is the NCT04937998 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT04937998 clinical trial?
NCT04937998 is sponsored by Istituto Ortopedico Rizzoli. The principal investigator is Alessandro Di Martino, MD at Istituto Ortopedico Rizzoli. The trial plans to enroll 166 participants.