Lipogems International spa
The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus saline 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 saline.
Knee Osteoarthritis
Osteo Arthritis Knee
Microfragmented Adipose Tissue derived using the Lipogems® System
Saline Injection
PHASE3
This study will investigate The Lipogems System in a clinical study to examine the effect of adipose tissue processed using The Lipogems System in comparison to saline 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.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 173 participants |
Masking : | TRIPLE |
Masking Description : | Triple (Participant, Investigator, Outcomes Assessor) Sponsor, Investigator, Participant are blinded. Unblinded operator will perform procedure. |
Primary Purpose : | TREATMENT |
Official Title : | A Randomized, Multi-center, Double Blind, Parallel Study to Examine the Effect of Lipogems Processed Microfragmented Adipose Tissue in Comparison to Saline for the Treatment of Knee Osteoarthritis |
Actual Study Start Date : | 2024-03-15 |
Estimated Primary Completion Date : | 2025-04-30 |
Estimated Study Completion Date : | 2025-04-30 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
Arizona Bone, Joint and Sports Medicine Center LLC
Phoenix, arizona, United States, 85012
RECRUITING
Mayo Clinic - Arizona
Scottsdale, arizona, United States, 85259
RECRUITING
CORE Orthopaedic Medical Center
Encinitas, California, United States, 92024
RECRUITING
Horizon Clinical Research
The Table, California, United States, 91942
WITHDRAWN
Restore Orthopedics and Sports Medicine
Sonora, California, United States, 95370
NOT YET RECRUITING
Baptist Health South Florida, Inc.
Boca Raton, Florida, United States, 33486
RECRUITING
Andrews Research & Ed Foundation
Gulf Breeze, Florida, United States, 32561
RECRUITING
Hospital for Special Surgery Florida
West Palm Beach, Florida, United States, 33401
RECRUITING
Pinnacle Trials, Inc
Atlanta, Georgia, United States, 30327
RECRUITING
Duly Health (NextStage)
Oak Lawn, Illinois, United States, 60453
RECRUITING
Ochsner Sports Medicine Institute
New Orleans, Louisiana, United States, 70121
RECRUITING
Regenerative Orthopedics & Sports Medicine
Rockville, Maryland, United States, 20852
RECRUITING
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55905
RECRUITING
The Orthopedic Center - NextStage Clinical Research - Tulsa
Tulsa, Oklahoma, United States, 74104
RECRUITING
LeHigh Center for Clinical Research
Allentown, Pennsylvania, United States, 18104
RECRUITING
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
RECRUITING
Vanderbilt Orthopaedics
Nashville, Tennessee, United States, 37209
WITHDRAWN
Ten20Medical Research
Addison, Texas, United States, 75001
RECRUITING
All American Ortho - NextStage Clinical Research
Houston, Texas, United States, 77058
RECRUITING
Texas Center for Cell Therapy and Research, LLC
Saint Anthony, Texas, United States, 78240