Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid (OA-bi-Blind)
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|ClinicalTrials.gov Identifier: NCT03110679|
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : August 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee||Biological: injection of autologous bone marrow concentrate Biological: injection of hyaluronic acid.||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||autologous bone marrow concentrate vs. hyaluronic acid.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||cover the syringe to mask the contents|
|Official Title:||Randomized Double-blind Study on the Treatment of Osteoarthritis of the Bilateral Knee: Autologous Bone Marrow Concentrate vs. Hyaluronic Acid|
|Actual Study Start Date :||February 18, 2016|
|Estimated Primary Completion Date :||August 2019|
|Estimated Study Completion Date :||February 2021|
Experimental: autologous bone marrow concentrate
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.
Biological: injection of autologous bone marrow concentrate
Experimental: hyaluronic acid.
single injection of intra-articular hyaluronic acid 60mg (4 cc), and serve as a control.
Biological: injection of hyaluronic acid.
- International Knee Documentation Committee (IKDC)-Subjective score [ Time Frame: Time Frame: 6 months ]Clinical improvement, measured by the change in scores IKDC Subjective
- International Knee Documentation Committee (IKDC)-Subjective score [ Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation ]Stability of the initial clinical improvement between 6 and 24 months
- Knee Injury and Osteoarthitis Outcome Score (KOOS). [ Time Frame: Time Frame: 1,3,6, 12, 24 months evaluation ]Stability of the initial clinical improvement between 6 and 24 months of the KOOS pain score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03110679
|Rizzoli Orthopaedic Institute||Recruiting|
|Bologna, Italy, 40136|
|Contact: Elizaveta Kon, MD 0516366567 firstname.lastname@example.org|
|Contact: Giuseppe Filardo, MD 0516366501|