Department of Orthopaedic Surgery, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University, Yishan Road 600#, Shanghai, 200233, China.
Department of Orthopedic Surgery, People's Hospital of Macheng City, Huang Gang, 438399, China.
BMC Musculoskelet Disord. 2022 Aug 16;23(1):781. doi: 10.1186/s12891-022-05714-x.
This study aimed at investigating the characteristics of clinical trials related to hip fractures that were registered at ClinicalTrials.gov. It also aimed to identify potential risk factors associated with completion.
We obtained 733 clinical studies related to hip fractures from the ClinicalTrials.gov database and included 470 studies in the analysis. These clinical trials were divided into behavioral, drug/biological, device, procedure, and other categories based on intervention types. Clinical trials investigating drugs or biologics were categorized based on the specific agents administered in each trial. Multiple logistic and Cox regression models were used to test the ability of 24 potential risk factors in predicting recruitment status and completion time, respectively. Among the included clinical trials, 44.89% (211/470) had complete recruitment status. The overall median completion time was 931.00 days (95% confidence interval [CI]: 822.56-1039.44 days). The results of only 8.94% (42/470) of clinical trials were presented on the ClinicalTrials.gov website. Bupivacaine (a local anesthetic) was most commonly investigated (in 25 clinical trials); this was followed by ropivacaine (another local anesthetic, 23 clinical trials) and tranexamic acid (a hemostatic, 21 clinical trials). Multivariate analysis showed that trials including children (P = 0.03) and having National Institutes of Health funds (P < 0.01) had significantly higher rates of complete recruitment. Higher enrollment (P < 0.01), National Institutes of Health funding (P < 0.01), location in the United States (P = 0.04), and location in Europe (P = 0.03) predisposed to longer completion time, while studies involving drugs/biologics (P < 0.01) had shorter completion times.
A considerable proportion of clinical trials related to hip fractures were completed, but the results of only a small fraction were presented on the ClinicalTrials.gov website. The commonly investigated drugs focused on anesthesia, pain relief, and hemostasis. Several independent risk factors that affect recruitment status and completion time were identified. These factors may guide the design of clinical trials relating to hip fractures.
本研究旨在调查在 ClinicalTrials.gov 上注册的与髋部骨折相关的临床试验的特点，并确定与完成相关的潜在风险因素。
我们从 ClinicalTrials.gov 数据库中获得了 733 项与髋部骨折相关的临床研究，并将其中的 470 项研究纳入分析。这些临床试验根据干预类型分为行为、药物/生物、器械、程序和其他类别。根据每个试验中使用的特定药物，对研究药物或生物制剂的临床试验进行了分类。使用多变量逻辑和 Cox 回归模型分别测试了 24 个潜在风险因素预测招募状态和完成时间的能力。在纳入的临床试验中，44.89%（211/470）的招募状态完全完成。总体中位数完成时间为 931.00 天（95%置信区间[CI]：822.56-1039.44 天）。ClinicalTrials.gov 网站仅公布了 8.94%（42/470）的临床试验结果。布比卡因（一种局部麻醉剂）是最常被研究的药物（25 项临床试验）；其次是罗哌卡因（另一种局部麻醉剂，23 项临床试验）和氨甲环酸（一种止血剂，21 项临床试验）。多变量分析显示，纳入儿童的试验（P=0.03）和获得美国国立卫生研究院资金的试验（P<0.01）完成完整招募的比例显著更高。更高的入组率（P<0.01）、美国国立卫生研究院资金（P<0.01）、试验地点在美国（P=0.04）和试验地点在欧洲（P=0.03）会导致更长的完成时间，而涉及药物/生物制剂的研究（P<0.01）完成时间更短。
相当一部分与髋部骨折相关的临床试验已完成，但仅一小部分临床试验结果在 ClinicalTrials.gov 网站上公布。常被研究的药物主要集中在麻醉、止痛和止血方面。确定了几个影响招募状态和完成时间的独立风险因素。这些因素可能指导髋部骨折相关临床试验的设计。
