NCT04901273

Homologous PRP vs Placebo in Knee Osteoarthritis in Over 65 Years Old Patients

Homologous PRP Versus Placebo in the Infiltrative Treatment of Knee Osteoarthritis in Over 65 Years Old Patients.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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 (Homologous PRP). Patients will be followed-up with clinical evaluation at 1,3 and 6 months. During the follow-up visits ,will be evaluated the inflammatory status of the knee by thermographic assessment. Patients in the treatment arm (Homologous PRP) will be followed for an additional 6 months (up to 12 months of follow-up). After 6 months, patients in the control arm have the possibility to cross-over into the treatment arm, in which case they will be followed for an additional 12 months.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Homologous PRP injections	Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.
PROCEDURE	Placebo injection (saline solution)	Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by osteoarthritis

Timeline

• Start date: 2021-12-15
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2021-05-25
• Last updated: 2025-08-03

Locations

1 site across 1 country: Italy