Comparing PRP and HA injections for knee osteoarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the clinical outcomes of patients with patellofemoral osteoarthritis receiving either autologous platelet-rich plasma (PRP) or hyaluronic acid (HA) injections. A total of 166 patients will be enrolled in a double-blinded randomized controlled trial, with one group receiving PRP and the other receiving HA. Participants will be monitored over a 24-month period, with clinical evaluations and questionnaires administered at baseline and follow-up visits at 2, 6, 12, and 24 months to assess treatment effectiveness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Alessandro Di Martino, MD — Istituto Ortopedico Rizzoli
• Study coordinator: Roberta Licciardi, MSc
• Email: roberta.licciardi@ior.it
• Phone: 0516366567

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.