Abstract:

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.

Key words: Femoroacetabular impingement, Clinical research, Database, Study characteristics