Comparing PRP injections to placebo for knee osteoarthritis in older adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of a single injection of Homologous Platelet-Rich Plasma (PRP) compared to a placebo (saline solution) in treating knee osteoarthritis in patients over 65 years old. A total of 204 participants will be enrolled in a double-blinded randomized controlled trial, with clinical evaluations conducted at 1, 3, and 6 months post-treatment. Patients in the placebo group will have the option to cross-over to the treatment group after 6 months, allowing for an extended follow-up period of up to 12 months for those receiving PRP. The study will assess both subjective and objective outcomes, including inflammatory status through thermographic assessment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Unilateral involvement;
2. Signs and symptoms of degenerative pathology of the knee cartilage;
3. Radiographic or MRI signs of degenerative pathology of the knee cartilage (Kellgren-Lawrence 1-4 grades);
4. Ability and consent of patients to actively participate in clinical follow-up;
5. Signature of informed consent

Exclusion Criteria:

1. Patients undergoing knee surgery within the previous 12 months;
2. Patients with malignant neoplasms;
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with hematologic diseases (coagulopathies);
6. Patients with metabolic disorders of the thyroid gland;
7. Patients abusing alcoholic beverages, drugs or medications
8. Body Mass Index \> 35

Where it's running

• Istituto Ortopedico Rizzoli
  Bologna, Italy Recruiting

Study contacts

• Principal investigator: Alessandro Di Martino, MD — Istituto Ortopedico Rizzoli
• Study coordinator: Roberta Licciardi, Msc
• Email: roberta.licciardi@ior.it
• Phone: 0516366567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.