Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients
Key facts
- Who runs it
- Istituto Ortopedico Rizzoli
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 204 people, planned
- Started
- 15 Dec 2021
- Expected to end
- Dec 2028
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Homologous PRP injections
- Placebo injection (saline solution)
- Record updated
- 3 August 2025
Who can take part
- Age
- 65 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 13 criteriaShow less
Who can take part
- 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
Who cannot take part
- Patients undergoing knee surgery within the previous 12 months
- Patients abusing alcoholic beverages, drugs or medications
- Patients with malignant neoplasms
- Patients with rheumatic diseases
- Patients with diabetes
- Patients with hematologic diseases (coagulopathies)
- Patients with metabolic disorders of the thyroid gland
- Body Mass Index > 35
Where in Italy
- Istituto Ortopedico RizzoliBologna, ItalyContact: Alessandro Di Martino, MDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Homologous PRPTreatment being tested
This group of patients will be treated with single intra-articular injection of Homologous PRP. At the 6-month follow-up visit, the patient will be informed about the treatment received.
Treatment: Homologous PRP injections
- Saline solutionPlacebo, for comparison
This group of patients will be treated with single intra-articular injection of saline solution (placebo). At the 6-month follow-up visit, patients will be informed about the treatment received. Patients of this group can cross-over to the treatment arm after 6 months.
Treatment: Placebo injection (saline solution)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.
- Record updated
- 3 August 2025