OA-bi-Blind is a randomized double-blind study on the treatment of osteoarthritis of the Bilateral knee: autologous bone marrow concentrate vs. hyaluronic acid.
a randomized, controlled, double-blind study and we will be evaluated and compared the clinical and radiological results of concentrated autologous bone marrow against the hyaluronic acid in patients with bilateral knee osteoarthrosis . In randomization, one knee will be treated with autologous bone marrow concentrate and other knee with hyaluronic acid, then every patient is considered both in control and treatment group, limiting the heterogenity between groups and will not be informed of the knee assigned to the treatment group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Rizzoli Orthopaedic Institute
Bologna, Italy
International Knee Documentation Committee (IKDC)-Subjective score
Clinical improvement, measured by the change in scores IKDC Subjective
Time frame: Time Frame: 6 months
International Knee Documentation Committee (IKDC)-Subjective score
Stability of the initial clinical improvement between 6 and 24 months
Time frame: Time Frame: 1,3,6, 12, 24 months evaluation
Knee Injury and Osteoarthritis Outcome Score (KOOS).
Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score
Time frame: Time Frame: 1,3,6, 12, 24 months evaluation
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