PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT
Recruiting · NCT04937998 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
Autologous PRP injectionHA injection
What this trial is 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
Who can take part
Age range
30 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Age between 30 and 65;
- Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
- 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. \[PMID: 2302884 - PMID: 27979409\] ;
- Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC exam);
- No clinically significant electrocardiographic alterations (Recently performed ECG).
- Ability and consent of patients to actively participate in clinical follow-up;
- Signature of informed consent.
Exclusion criteria
- Patients unable to express consent;
- Patients who have undergone intra-articular infiltration of another substance within the previous 6 months;
- Patients undergoing knee surgery within the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with diabetes;
- Patients with hematologic diseases (coagulopathies);
- Patients on anticoagulant-antiaggregant therapy;
- Patients with thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index \> 35;
- Patients who have taken NSAIDs in the 3 days prior to blood draw;
- Patients with cardiovascular disease for which a 60 mL blood draw would be contraindicated;
- Patients with a recently performed blood test with Hb\< 11 g/dl and Platelets \< 150,000 plt/mm3.
- Previous treatment of patellar dislocation
- Iwano score of grade 4.
Where it is running
1 location listed.
- Istituto Ortopedico Rizzoli - Bologna, Italy