Comparing PRP injections to placebo for knee osteoarthritis in older adults
Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.
NA · Istituto Ortopedico Rizzoli · NCT04901273
This study is testing if a single injection of platelet-rich plasma can help older adults with knee osteoarthritis feel better compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 204 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Locations | 1 site (Bologna) |
| Trial ID | NCT04901273 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals over 65 years old with unilateral knee osteoarthritis and radiographic evidence of degenerative changes.
Not a fit: Patients with recent knee surgery, malignancies, rheumatic diseases, diabetes, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant pain relief and improved function for older patients suffering from knee osteoarthritis.
How similar studies have performed: Previous studies have shown promising results with PRP injections for knee osteoarthritis, suggesting potential efficacy for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bologna
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Knee Osteoarthritis, knee, knee osteoarthritis, PRP, Homologous PRP, PRP injections, injection treatment, Randomized controlled trial