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首页> 外文期刊>Trials >Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18–50?years) femoroacetabular impingement: a statistical analysis plan
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Femoroacetabular Impingement Randomised controlled Trial (FIRST) - a multi-centre randomized controlled trial comparing arthroscopic lavage and arthroscopic osteochondroplasty on patient important outcomes and quality of life in the treatment of young adult (18–50?years) femoroacetabular impingement: a statistical analysis plan

机译：股骨旁抗冲击随机对照试验（第一） - 一种多中心随机对照试验，比较关节镜灌洗和关节镜骨骨骨膜术对患者的重要成果和生活质量，治疗年轻成人（18-50岁）股骨旁的冲击：统计分析计划

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摘要

The research objectives of the Femoroacetabular Impingement Randomised controlled Trial (FIRST) are to assess whether surgical correction of the hip impingement morphology (arthroscopic osteochondroplasty) with or without labral repair, in adults aged 18-50 years diagnosed with non-arthritic femoroacetabular impingement (FAI), provides decreased pain and improved health-related quality of life at 12?months compared to arthroscopic lavage of the hip joint. This article describes the statistical analysis plan for the FIRST trial. FIRST is an ongoing multi-centre, blinded randomised controlled trial of 220 patients who have been diagnosed with FAI and are optimized for surgical intervention. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of the results, adjustments for covariates, the primary and secondary outcomes and their respective analyses. In addition, we will present the planned sensitivity and subgroup analyses. Our rationale for FIRST is based upon (1) an epidemic of FAI surgery with resultant increased healthcare costs over that last decade, (2) worldwide disparity in perceptions about its utility, and (3) consensus that definitive evidence for or against surgical approaches is lacking. ClinicalTrials.gov, NCT01623843 . Registered on 20 June 2012.
机译：股股撞击随机对照试验（第一）的研究目的是评估髋关节冲击形态（关节镜骨骨膜术）的手术校正是否有或没有效果修复，诊断为非关节炎股骨悚然的冲击（FAI ），与髋关节关节关节血管灌洗相比，提供减少的疼痛和有关的健康状生活质量。本文介绍了第一次试验的统计分析计划。首先是持续的多中心，盲目的随机对照试验，220名患者被诊断出患有FAI，并针对手术干预进行了优化。本文介绍了整体分析原则，包括参与者将如何包含在每次分析中，展示结果的展示，协变量的调整，初级和二次结果及其各自的分析。此外，我们将介绍计划的敏感性和亚组分析。我们的理由首先是基于（1）FAI手术流行，在过去十年中，（2）对其实用程序的看法，（2）全球差异，（3）符合明确证据或针对手术方法的共识不足。 ClinicalTrials.gov，NCT01623843。 2012年6月20日注册。

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