Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients
Recruiting · NCT04901273 · Interventional (participants receive a specific treatment) · Lead sponsor: Istituto Ortopedico Rizzoli
View the official record on ClinicalTrials.gov →Interventions studied
Homologous PRP injectionsPlacebo injection (saline solution)
What this trial is about
The aim of the study is to compare the 6 months clinical outcome of the treatment with a single injection of Homologous PRP versus single injection of placebo (saline solution) in the infiltrative treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.
Who can take part
Age range
65 Years and older
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
- Unilateral involvement;
- Signs and symptoms of degenerative pathology of the knee cartilage;
- Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
- Ability and consent of patients to actively participate in clinical follow-up;
- Signature of informed consent
Exclusion criteria
- 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 with metabolic disorders of the thyroid gland;
- Patients abusing alcoholic beverages, drugs or medications
- Body Mass Index \> 35
Where it is running
1 location listed.
- Istituto Ortopedico Rizzoli - Bologna, Italy