Randomized, controlled, three-arm, double-blind study : control group, treated with core decompression technique VS subchondral plasty by injecting i-FactorTM VS injections of autologous BMC.
The clinical trial is a randomized, controlled, three-arm, double-blind study, involving up to 120 patients. Eligible subjects will be randomly allocated to one of the three treatment groups: control group, treated with core decompression technique, study group 1, treated with subchondral plasty by injecting i-FactorTM, and study group 2, treated by injections of autologous BMC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
injection of autologous bone marrow concentrate
subchondral injections of i-FactorTM
subchondral anterograde drilling
Rizzoli Orthopaedic Institute
Bologna, Italy
change of Visual Analogue Scale (VAS) score
improvement in VAS score from baseline to follow up
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
International Knee Documentation Committee (IKDC) subjective score
improvement in IKDC subjective score from baseline to follow up
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Knee Injury and Osteoarthritis Outcome (KOOS) Score
improvement in KOOS score from baseline to follow up
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
Tegner Activity Level Scale
improvement in activity level scale from baseline to follow up
Time frame: [Timepoint: Screening, 1 , 3 6, 12, 24 months]
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