Status:
RECRUITING
Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients
Lead Sponsor:
Istituto Ortopedico Rizzoli
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
65+ years
Phase:
NA
Brief Summary
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 tre...
Detailed 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 (Homolog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT04901273
Start Date
December 15 2021
End Date
December 1 2028
Last Update
August 3 2025
Active Locations (1)
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1
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136