Department of Radiology, Aarhus University Hospital, Noerrebrogade 44, 8000 Aarhus, Denmark; The Parker Institute, Copenhagen University Hospital Bispebjerg-Frederiksberg, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark.
Department of Radiology, Bispebjerg and Frederiksberg Hospital, Ndr. Fasanvej 57, 2000 Frederiksberg, Denmark.
Osteoarthritis Cartilage. 2018 Jul;26(7):895-902. doi: 10.1016/j.joca.2018.02.900. Epub 2018 Mar 2.
To evaluate if the relative volume of bone marrow lesions (BMLs) changed in patients with knee osteoarthritis (OA) during a therapeutic study.
This study is a sub-study to a larger clinical trial which compared the clinical effects of intra-articular corticosteroid injection in knee OA to placebo injection, both given prior to exercise therapy. Clinical assessment using the Knee injury and Osteoarthritis Outcome Score (KOOS) and magnetic resonance imaging (MRI) examinations with BML assessments were performed at baseline and follow-up after 14 weeks and 26 weeks, respectively. The BML volume was determined using a computer assisted method focusing on participants with valid baseline and follow-up MRI examinations. Any changes in BML and KOOS were analyzed and investigated for associations.
Fifty participants received steroid and placebo injection, respectively, of which 41 and 45 had complete MRI examinations at week 14, and 36 and 33 at week 26, respectively. All participants received 12 weeks of exercise. A significant change in relative BML volume was observed between the corticosteroid group and the placebo group after 14 weeks [-1.1% vs 2.7%; between-group difference, 3.8% (95% CI 0.5-7.0)] but not after 26 weeks [0.8% vs 1.6%; between-group difference, 0.8% (95% CI -2.8 to 4.4)]. No significant association was found between changes in relative BML volume and KOOS.
Despite the statistically significant difference in BML volume at 14 weeks after corticosteroid injection and 12 weeks exercise therapy compared to placebo injection and exercise, there is very little evidence on a relationship between corticosteroids and BML volume.
EudraCT number: 2012-002607-18.
评估膝骨关节炎（OA）患者在治疗研究过程中骨髓病变（BML）的相对体积是否发生变化。
本研究是一项更大的临床试验的子研究，该临床试验比较了关节内皮质类固醇注射与安慰剂注射在膝 OA 中的临床效果，两者均在运动治疗前进行。临床评估使用膝关节损伤和骨关节炎结果评分（KOOS）和磁共振成像（MRI）检查，分别在基线和 14 周及 26 周后进行 BML 评估。使用计算机辅助方法确定 BML 体积，重点关注具有有效基线和随访 MRI 检查的参与者。分析并研究了 BML 和 KOOS 的任何变化及其相关性。
50 名参与者分别接受了皮质类固醇和安慰剂注射，其中 41 名和 45 名在第 14 周时有完整的 MRI 检查，36 名和 33 名在第 26 周时有完整的 MRI 检查，所有参与者均接受了 12 周的运动治疗。在 14 周时，皮质类固醇组和安慰剂组的相对 BML 体积有显著变化[-1.1%比 2.7%；组间差异，3.8%（95%CI 0.5-7.0）]，但在 26 周时无显著变化[0.8%比 1.6%；组间差异，0.8%（95%CI-2.8 至 4.4）]。未发现相对 BML 体积变化与 KOOS 之间存在显著相关性。
尽管皮质类固醇注射后 14 周和运动治疗 12 周与安慰剂注射和运动相比，BML 体积有统计学上的显著差异，但皮质类固醇与 BML 体积之间的关系证据很少。
EudraCT 编号：2012-002607-18。
