Recruiting
Not applicable
PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT
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
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)
| Facility | City | Region | Status |
| Istituto Ortopedico Rizzoli |
Bologna |
Italy |
Recruiting |
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