PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Patellofemoral Osteoarthritis

Treatments: Procedure: HA injection; Procedure: Autologous PRP injection

Study type: Interventional

Funder types: Other

Identifiers

NCT04937998

PRP-21

Details and patient eligibility

About

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

Full description

166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.

Enrollment: 166 estimated patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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166 participants in 2 patient groups

Autologous PRP injection

Experimental group

Description:

This group of patients will be treated with single intra-articular injection of Autologous PRP.

Treatment:

Procedure: Autologous PRP injection

HA injection

Active Comparator group

Description:

This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA)

Treatment:

Procedure: HA injection