Rizzoli Orthopaedic Institute
Bologna, 40136, Italy
NCT Number: NCT03110679
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.
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Notify Me18 year–75 year
All sexes
Interventional
Phase 4
Bologna, 40136, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Time Frame: 6 months
Clinical improvement, measured by the change in scores IKDC Subjective
Time frame: Time Frame: 1,3,6, 12, 24 months evaluation
Stability of the initial clinical improvement between 6 and 24 months
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
Istituto Ortopedico Rizzoli
Other
Acronym: OA-bi-Blind
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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