Comparing PRP and HA injections for knee osteoarthritis

THE USE OF FRESH PRP VS HA IN THE TREATMENT OF OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT Randomized Controlled Clinical Trial

This study is testing whether injections of platelet-rich plasma or hyaluronic acid can help people with knee osteoarthritis feel better over two years.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 166 (estimated)
• Ages: 30 Years to 65 Years
• Sex: All
• Sponsor: Istituto Ortopedico Rizzoli (other)
• Locations: 1 site (Bologna)
• Trial ID: NCT04937998 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 30 to 65 with isolated patellofemoral osteoarthritis symptoms and radiographic evidence of the condition.

Not a fit: Patients with recent knee surgeries, significant comorbidities, or those unable to consent may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients suffering from patellofemoral osteoarthritis.

How similar studies have performed: Previous studies have shown promising results with both PRP and HA injections in treating osteoarthritis, suggesting potential for success in this approach.

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.

Where this trial is running

Bologna

• Istituto Ortopedico Rizzoli — Bologna, Italy (RECRUITING)

Study contacts

• Principal investigator: Alessandro Di Martino, MD — Istituto Ortopedico Rizzoli
• Study coordinator: Roberta Licciardi, MSc

Conditions: Patellofemoral Osteoarthritis, PRP, HA, Osteoarthritis, Autologous PRP, PRP injection, HA injection, injection treatment