NCT04567732

Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

Randomized Double Blind Clinical Study on the Treatment of Bilateral Knee Arthrosis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis. After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.

Detailed description

All patients who meet the inclusion criteria and giving written informed consent will be randomized. Every patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization. After the treatment patients will be followed up to 24 months.

Conditions

• Bilateral Knee Osteoarthritis
• Autologous Adipose Tissue

Interventions

Type	Name	Description
COMBINATION_PRODUCT	injection of Filtered Autologous Adipose Tissue	Single injection of Filtered Autologous Adipose Tissue
DRUG	Placebo	Single injection of Placebo

Timeline

• Start date: 2021-02-22
• Primary completion: 2022-04-22
• Completion: 2026-04-01
• First posted: 2020-09-28
• Last updated: 2025-08-03

Locations

1 site across 1 country: Italy