Overview
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.
Description
204 patients affected by knee osteoarthritis will be included in a double-blinded RCT with possibility ,after 6 months, to cross-over from control arm ( saline solution ) to the treatment arm (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.
Eligibility
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