A Phase 4 interventional study of injection of autologous bone marrow concentrate and injection of hyaluronic acid. in Osteoarthritis, Knee, sponsored by Istituto Ortopedico Rizzoli. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-04.
Sponsored by Istituto Ortopedico Rizzoli · Phase 4, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 60 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Istituto Ortopedico Rizzoli is the lead sponsor of 298 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Istituto Ortopedico Rizzoli