ITCMDBv1
Clinical TrialID 8433

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

NCT06121882

Knee Osteoarthritis|Osteo Arthritis Knee

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Record Fields

Scalar fields from the final clinical_trial record.

Clinical Trial Id
8433
Evidence Id
8433
Core Evidence Id
8433
Source Clinical Trial Id
8431
Herb2 Clinical Trial Id
HBCT008431
Nct Id
NCT06121882
Title
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
Status
Recruiting
Phase
Phase 3
Study Result
No
Study Condition
Knee Osteoarthritis|Osteo Arthritis Knee
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DEVICE: Microfragmented Adipose Tissue derived using the Lipogems® System|DRUG: Saline Injection
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Adult, Older_Adult
Enrollment
173
Outcome Measure
Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score, The change from baseline to Month 12 for the Western Ontario and McMaster Universities Osteoarthritis Index pain (WOMAC-A) subscale score (superiority); Scale = 0-100, where 100 is extreme pain, 12-month visit|Change in WOMAC-C (function) Subscale Score, The change from baseline to Month 12 for the Western Ontario and McMaster Universities Osteoarthritis Index function (WOMAC-C) subscale score (non-inferiority), scale 0-100, where 100 is extreme difficulty performing a function., 12-month visit
Sponsor Collaborator
Lipogems International spa|Alira Health
Funded By
INDUSTRY
Location
Arizona Bone, Joint and Sports Medicine Center LLC, Phoenix, Arizona, 85012, United States|Mayo Clinic - Arizona, Scottsdale, Arizona, 85259, United States|CORE Orthopaedic Medical Center, Encinitas, California, 92024, United States|Horizon Clinical Research, La Mesa, California, 91942, United States|Restore Orthopedics and Sports Medicine, Sonora, California, 95370, United States|Baptist Health South Florida, Inc., Boca Raton, Florida, 33486, United States|Andrews Research & Ed Foundation, Gulf Breeze, Florida, 32561, United States|Hospital for Special Surgery Florida, West Palm Beach, Florida, 33401, United States|Pinnacle Trials, Inc, Atlanta, Georgia, 30327, United States|Duly Health (NextStage), Oak Lawn, Illinois, 60453, United States|Ochsner Sports Medicine Institute, New Orleans, Louisiana, 70121, United States|Regenerative Orthopedics & Sports Medicine, Rockville, Maryland, 20852, United States|Mayo Clinic - Rochester, Rochester, Minnesota, 55905, United States|The Orthopedic Center - NextStage Clinical Research - Tulsa, Tulsa, Oklahoma, 74104, United States|LeHigh Center for Clinical Research, Allentown, Pennsylvania, 18104, United States|Coastal Carolina Research Center, North Charleston, South Carolina, 29405, United States|Vanderbilt Orthopaedics, Nashville, Tennessee, 37209, United States|Ten20Medical Research, Addison, Texas, 75001, United States|All American Ortho - NextStage Clinical Research, Houston, Texas, 77058, United States|Texas Center for Cell Therapy and Research, LLC, San Antonio, Texas, 78240, United States
Other Id
LIPO-002
Start Date
2024-03-15
Primary Completion Date
2025-04-30
Completion Date
2025-04-30
First Posted
2023-11-08
Results First Posted
Last Update Posted
2024-08-26
Study Document
Study Url
https://clinicaltrials.gov/study/NCT06121882
Title Cn
Title En
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
Bilingual Status
semi_complete