Ireland
--:--IST
Recruiting Not applicable

PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

NCT04937998 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2022-10-26
Last updated
2025-12-04

Condition(s) studied

Patellofemoral Osteoarthritis

Investigational drug(s) / intervention(s)

Autologous PRP injectionHA injection

Autologous PRP injection: Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis

HA injection: Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis

Study 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

Sex
ALL
Min age
30 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • KOOS-Pain Score — 12 months
    KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".

Trial sites (1)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04937998 on ClinicalTrials.gov ↗ ← All trials in Italy