The purpose of this trial is to compare the effect of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate on pain reduction and functional improvement in the treatment of the knee and hip OA.
The primary objective is to compare of magnitude and duration of pain relief of intra-articular injections with Lipoaspirate Concentrate vs Bone Marrow Aspirate. The secondary objective is to compare the effect of Lipoaspirate Concentrate vs Bone Marrow Aspirate intra-articular injections on functional improvement, stiffness, global impression of change, and consumption of analgesic medication. The exploratory objective is to explore the safety and the general tolerability of a single intra-articular injection of Lipoaspirate Concentrate vs Bone Marrow Aspirate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Autologous Cell Therapy.
Karmy Clinic
Brampton, Ontario, Canada
RECRUITINGThe primary endpoint is the change from the Baseline to the Day 360 in WOMAC pain subscale pain subscale
Time frame: 360 days
Change from Baseline to Days 90, 180 in WOMAC pain subscale
Time frame: 90, 180 days
Change from Baseline to Days 90, 180, and 360 in WOMAC stiffness subscale
Time frame: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in WOMAC function subscale
Time frame: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in total WOMAC score
Time frame: 90, 180, 360 days
Change from Baseline to Days 90, 180, and 360 in Patient's Global Impression of Changes (PGIC)
Time frame: 90, 180, 360 days
Change in average weekly consumption of analgesic medications from Baseline to Day 90, 180, and 360
Time frame: 90, 180, 360 days
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