NCT05660772

Microfragmented Adipose Tissue Compared to Corticosteroid Injection for the Treatment of Knee Osteoarthritis

A Randomized, Multi-center, Double Blind, Parallel Study to Examine the Effect of Lipogems Processed Microfragmented Adipose Tissue in Comparison to Corticosteroid for the Treatment of Knee Osteoarthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Lipogems International spa · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus corticosteroid injection for the treatment of pain and function associated with K/L grade 2/3 knee Osteoarthritis. Participants will receive an injection of MFat or a corticosteroid.

Detailed description

This study will investigate The Lipogems System in a clinical study to examine the effect of micro fragmented adipose tissue processed using The Lipogems System in comparison to corticosteroid for the treatment of knee osteoarthritis. This study will be randomized and double-blinded. The subjects will be randomized at a 2:1 ratio (investigational to control) and will enroll 173 patients at up to 20 sites in the United States.

Conditions

• Knee Osteoarthritis
• Osteo Arthritis Knee

Interventions

Type	Name	Description
DEVICE	Microfragmented Adipose Tissue	Microfragmented Adipose Tissue derived using Lipogems® Kit
DRUG	Corticosteroid	intra-articular knee injection of corticosteroid

Timeline

• Start date: 2022-12-30
• Primary completion: 2025-04-09
• Completion: 2025-04-09
• First posted: 2022-12-21
• Last updated: 2025-04-22

Locations

18 sites across 1 country: United States

Regulatory

• FDA-regulated device study