目的

分析在美国临床试验数据库（ClinicalTrials.gov）和中国临床试验注册中心（ChiCTR）注册发布的股髋撞击综合征（FAIS）临床研究的信息特征，比较国内外研究差异，为开展后续临床研究提供借鉴。

方法

在美国临床试验数据库和中国临床试验注册中心数据库进行检索，纳入自建库至2023年12月31日注册发布且研究信息完整的FAIS临床研究，排除非临床研究和信息不完整的数据。分析临床研究数量、国家分布、研究的状态、资助情况、研究类型、入组人数、干预方式、研究设计等特征，并采用IBM SPSS 22.0软件运用频数和构成比对数据进行描述性统计和归纳分析。

结果

全球从2012年开始有FAIS临床研究项目在美国临床试验数据库注册发布，截至2023年底共检索到88项，其中完成的研究31项，正在招募受试者的17项；企业资助的临床试验（IST）8项，非企业资助的临床试验（IIT）80项；干预性研究58项，观察性研究30项；样本量以小于200例为主；研究干预方式以手术、药物、医疗器械为主，多采用随机、盲法、平行分配、治疗为目的的研究设计；常用的结局指标包括疼痛评分、iHOT-33国际髋关节评分、生活质量评分等；仅8项研究在数据库中发布了研究结果。中国在2020年首次于美国临床试验数据库发布FAIS临床研究，至检索截止日期共注册8项，排名第4；研究全部为观察性、单中心研究，主要由北京1家医院完成；在2019年首次于中国临床试验注册中心数据库发布FAIS临床研究，至检索截止日期共注册3项。

结论

我国FAIS临床研究起步较晚，开展FAIS研究的机构少，可以通过科学的方案设计如多中心、随机对照研究等获得循证医学证据，提升研究质量,促进临床实践。

Objective

To analyze the information characteristics of clinical research on femoroacetabular impact syndrome (FAIS) registered on ClinicalTrials.gov in the United States and Chinese Clinical Trial Registry (ChiCTR) in China, compare domestic and international research differences, and provide reference for the good management of followed-up research.

Methods

All the clinical research on FAIS were searched on ClinicalTrials.gov and ChiCTR.Inclusion criteria：FAIS clinical researches first posted on the above databases with complete information from inception to December 31st, 2023.Exclusion criteria：non-.clinical researches and clinical researches with incomplete information.The registration characteristics of research, such as number, country distribution, status, funder, study types, enrollment, interventions and study designs, etc., were summarized.IBM SPSS 22.0 software was used to perform descriptive statistics and inductive analysis on frequency and composition comparison data.

Results

Since 2012, FAIS clinical research had been registered and posted on ClinicalTrials.gov.A total of 88 clinical studies were collected.Among them,31 studies were completed and 17 studies were recruiting, eight studies were industry-sponsored and 80 studies were investigator-initiated, 58 studies were interventional studies and 30 were observational studies.The sample size is mainly less than 200 cases.The research intervention methods mainly focused on surgery, medication,and medical devices.Randomized, masking, parallel assignment, and treatment purpose study designs were mainly adopted.Common outcome measures included pain score, International Hip Outcome Tool-33, quality of life, etc.Only eight studies posted results.China first posted FAIS clinical studies on ClinicalTrials.gov in 2020, and a total of eight studies were registered, fouth in the world.Among them, mainly were observational and single center studies, and completed by one hospital in Beijing.On ChiCTR,China first posted FAIS clinical studies in 2019, and a total of three studies were registered.

Conclusions

Clinical research on FAIS in our country started relatively late, and there are few institutions conducting FAIS research.Evidence will be obtained through scientific protocol design based on evidence-based medicine, such as multicenter, randomized controlled studies, etc., to improve research quality and facilitate clinical practice.