Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 treatment of knee osteoarthritis in over 65 years old patients. The evaluation will be performed through clinical, subjective and objective assessments.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Italy
Istituto Ortopedico Rizzoli
RECRUITING
Bologna
Contact Information
Primary
Roberta Licciardi, Msc
roberta.licciardi@ior.it
0516366567
Backup
Alessandro Di Martino, MD
alessandro.dimartino@ior.it
Time Frame
Start Date: 2021-12-15
Estimated Completion Date: 2028-12
Participants
Target number of participants: 204
Treatments
Experimental: Homologous PRP
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.
Placebo_comparator: Saline solution
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.
Related Therapeutic Areas
Sponsors
Leads: Istituto Ortopedico Rizzoli