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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| autologous bone marrow concentrate | Experimental | concentration of bone marrow taken from the patient's right tibia using Bio-MAC® suction catheter, company Biologic Therapies, Inc., and concentrated by centrifuge Bio.SPINTM Magellan®, company Biologic Therapies , Inc., and its injection in the intra-articular. |
|
| hyaluronic acid. | Experimental | single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of autologous bone marrow concentrate | Biological |
| ||
| injection of hyaluronic acid. |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee (IKDC)-Subjective score | Clinical improvement, measured by the change in scores IKDC Subjective | Time Frame: 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| International Knee Documentation Committee (IKDC)-Subjective score | Stability of the initial clinical improvement between 6 and 24 months | Time Frame: 1,3,6, 12, 24 months evaluation |
| Knee Injury and Osteoarthritis Outcome Score (KOOS). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rizzoli Orthopaedic Institute | Bologna | 40136 | Italy |
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autologous bone marrow concentrate vs. hyaluronic acid.
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cover the syringe to mask the contents
| Biological |
|
Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score
| Time Frame: 1,3,6, 12, 24 months evaluation |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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