Department of Orthopedic Surgery, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Harbor-UCLA Medical Center, Torrance, CA, USA.
Cartilage. 2024 Dec;15(4):389-398. doi: 10.1177/19476035241233441. Epub 2024 Feb 25.
Marrow stimulation is used to address knee cartilage defects. In this study, we used the fragility index (FI), reverse fragility index (rFI), and fragility quotient (FQ) to evaluate statistical fragility of outcomes reported in randomized controlled trials (RCTs) evaluating marrow stimulation.
PubMed, Embase, and MEDLINE were queried for recent RCTs (January 1, 2010-September 5, 2023) assessing marrow stimulation for cartilage defects of the knee. The FI and rFI were calculated as the number of outcome event reversals required to alter statistical significance for significant and nonsignificant outcomes, respectively. The FQ was determined by dividing the FI by the study sample size.
Across 155 total outcomes from 21 RCTs, the median FI was 3 (interquartile range [IQR], 2-5), with an associated median FQ of 0.067 (IQR, 0.033-0.010). Thirty-two outcomes were statistically significant, with a median FI of 2 (IQR, 1-3.25) and FQ of 0.050 (IQR, 0.025-0.069). Ten of the 32 (31.3%) outcomes reported as statistically significant had an FI of 1. In total, 123 outcomes were nonsignificant, with a median rFI of 3 (IQR, 2-5). Studies assessing stem cell augments were the most fragile, with a median FI of 2. In 55.5% of outcomes, the number of patients lost to follow-up was greater than or equal to the FI.
Statistical findings in RCTs evaluating marrow stimulation for cartilage defects of the knee are statistically fragile. We recommend combined reporting of -values with FI and FQ metrics to aid in the interpretation of clinical findings in comparative trials assessing cartilage restoration.
骨髓刺激被用于治疗膝关节软骨缺损。在这项研究中，我们使用脆性指数（FI）、反向脆性指数（rFI）和脆性商数（FQ）来评估评价骨髓刺激治疗软骨缺损的随机对照试验（RCT）中报告结果的统计脆性。
检索了 PubMed、Embase 和 MEDLINE 中 2010 年 1 月 1 日至 2023 年 9 月 5 日的最新 RCT，评估了骨髓刺激治疗膝关节软骨缺损。FI 和 rFI 分别计算为需要逆转的结果事件数量，以改变显著和非显著结果的统计显著性。FQ 通过将 FI 除以研究样本量来确定。
在 21 项 RCT 的 155 项总结果中，中位数 FI 为 3（四分位距 [IQR]，2-5），相应的中位数 FQ 为 0.067（IQR，0.033-0.010）。32 项结果具有统计学意义，中位数 FI 为 2（IQR，1-3.25），FQ 为 0.050（IQR，0.025-0.069）。32 项有统计学意义的结果中有 10 项报告的 FI 为 1。总的来说，123 项结果无统计学意义，中位数 rFI 为 3（IQR，2-5）。评估干细胞增强的研究最脆弱，中位数 FI 为 2。在 55.5%的结果中，失访患者的数量大于或等于 FI。
评估骨髓刺激治疗膝关节软骨缺损的 RCT 中的统计结果存在统计学上的脆弱性。我们建议结合报告 - 值与 FI 和 FQ 指标，以帮助解释评估软骨修复的比较试验中的临床发现。
