Abstract | INTRODUCTION: METHODS AND ANALYSIS: Eighty-six patients with symptomatic knee OA (aged between 40 and 70 years) are randomised to BMAC intra-articular injection combined with subchondral BMAC injection or BMAC intra-articular injection alone in a ratio of 1:1. The primary outcome is the total Western Ontario and McMaster Universities Osteoarthritis Index, the secondary outcomes are the International Knee Documentation Committee Subjective and Objective Knee Evaluation Form, the Tegner activity scale, the EuroQol-Visual Analogue Scale, and the health questionnaire European Quality of Life Five Dimension score. Additional CT and MRI evaluations are performed at the baseline assessment and at the final 12-month follow-up. The hypothesis is that the combined injections provide higher knee pain and function improvement compared with BMAC intra-articular injection alone. The primary analysis follows an intention to treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the Emilia Wide Area Ethical Committee of the Emilia-Romagna Region (CE-AVEC), Bologna, Italy. Written informed consent is obtained from all the participants. Findings of this study will be disseminated through peer-reviewed publications and conference presentations. PROTOCOL VERSION: Version 1 (14 May 2018). TRIAL REGISTRATION NUMBER: NCT03876795.
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Authors | Simone Silva, Luca Andriolo, Angelo Boffa, Alessandro Di Martino, Davide Reale, Giulio Vara, Marco Miceli, Carola Cavallo, Brunella Grigolo, Stefano Zaffagnini, Giuseppe Filardo |
Journal | BMJ open
(BMJ Open)
Vol. 12
Issue 9
Pg. e062632
(09 08 2022)
ISSN: 2044-6055 [Electronic] England |
PMID | 36468635
(Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
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Copyright | © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. |
Topics |
- Adult
- Aged
- Humans
- Middle Aged
- Bone Marrow
- Injections, Intra-Articular
- Osteoarthritis, Knee
(diagnostic imaging, drug therapy)
- Prospective Studies
- Quality of Life
- Randomized Controlled Trials as Topic
- Double-Blind Method
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