骨髓刺激治疗膝关节软骨缺损的统计不稳定性：随机对照试验的系统回顾

IF 2.7 4区医学 Q1 ORTHOPEDICS

CARTILAGE Pub Date : 2024-12-01 Epub Date: 2024-02-25 DOI:10.1177/19476035241233441

Avanish Yendluri, Ara Alexanian, Rohit R Chari, John J Corvi, Nikan K Namiri, Junho Song, Michael J Alaia, Xinning Li, Robert L Parisien

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引用次数: 0

摘要

目的：骨髓刺激疗法用于治疗膝关节软骨缺损。在本研究中，我们使用脆性指数（FI）、反向脆性指数（rFI）和脆性商数（FQ）来评估评估骨髓刺激的随机对照试验（RCT）所报告结果的统计脆性：设计：在PubMed、Embase和MEDLINE上查询了近期（2010年1月1日至2023年9月5日）评估骨髓刺激治疗膝关节软骨缺损的RCT。FI和rFI分别计算为改变显著和不显著结果统计显著性所需的结果事件逆转数。FQ由FI除以研究样本量得出：在 21 项 RCT 的 155 项结果中，FI 的中位数为 3（四分位数间距 [IQR]，2-5），相关的 FQ 中位数为 0.067（IQR，0.033-0.010）。32项结果具有统计学意义，FI中位数为2（IQR，1-3.25），FQ中位数为0.050（IQR，0.025-0.069）。在32项有统计学意义的结果中，有10项（31.3%）的FI为1。共有123项结果无统计学意义，rFI中位数为3（IQR，2-5）。在55.5%的结果中，失去随访的患者人数大于或等于FI：结论：评估骨髓刺激治疗膝关节软骨缺损的 RCT 统计结果在统计学上非常脆弱。我们建议将P值与FI和FQ指标合并报告，以帮助解释评估软骨修复的比较试验中的临床结果。

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The Statistical Fragility of Marrow Stimulation for Cartilage Defects of the Knee: A Systematic Review of Randomized Controlled Trials.

Objective: 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.

Design: 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.

Results: 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.

Conclusion: Statistical findings in RCTs evaluating marrow stimulation for cartilage defects of the knee are statistically fragile. We recommend combined reporting of P-values with FI and FQ metrics to aid in the interpretation of clinical findings in comparative trials assessing cartilage restoration.

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来源期刊

CARTILAGE ORTHOPEDICS-

CiteScore

6.90

自引率

7.10%

发文量

期刊介绍： CARTILAGE publishes articles related to the musculoskeletal system with particular attention to cartilage repair, development, function, degeneration, transplantation, and rehabilitation. The journal is a forum for the exchange of ideas for the many types of researchers and clinicians involved in cartilage biology and repair. A primary objective of CARTILAGE is to foster the cross-fertilization of the findings between clinical and basic sciences throughout the various disciplines involved in cartilage repair. The journal publishes full length original manuscripts on all types of cartilage including articular, nasal, auricular, tracheal/bronchial, and intervertebral disc fibrocartilage. Manuscripts on clinical and laboratory research are welcome. Review articles, editorials, and letters are also encouraged. The ICRS envisages CARTILAGE as a forum for the exchange of knowledge among clinicians, scientists, patients, and researchers. The International Cartilage Repair Society (ICRS) is dedicated to promotion, encouragement, and distribution of fundamental and applied research of cartilage in order to permit a better knowledge of function and dysfunction of articular cartilage and its repair.