PDF(Pubmed)
Abstract：
BACKGROUND: Management controversy and clinical equipoise exist in treatments of long bone fractures and traumatic hip dislocation in paediatric patients due to the lack of high-quality clinical evidence. This protocol describes the effort of a large prospective global multicentre cohort study (registry) aiming at providing quality data to assist evidence-based treatment decision-making.
METHODS: Eligible paediatric patients (N=750-1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24-36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.
BACKGROUND: Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.
BACKGROUND: NCT04207892.
METHODS: Eligible paediatric patients (N=750-1000) with open physes suffering from proximal humerus fractures, distal humerus fractures, proximal radius fractures, forearm shaft fractures, traumatic hip dislocations, femoral neck fractures or tibial shaft fractures will be recruited over a period of 24-36 months. Hospitalisation and treatment details (including materials and implants) will be captured in a cloud-based, searchable database. Outcome measures include radiographic assessments, clinical outcomes (such as range of motion, limb length discrepancies and implant removal), patient-reported outcomes (Patient Reported Outcomes Of Fracture, Patient-Reported Outcomes Measurement Information System (PROMIS) and EuroQol-5D (EQ-5D-Y)) and adverse events.Aside from descriptive statistics on patient demographics, baseline characteristics, types of fractures and adverse event rates, research questions will be formulated based on data availability and quality. A statistical analysis plan will be prepared before the statistical analysis.
BACKGROUND: Ethics approval will be obtained before patients are enrolled at each participating site. Patient enrolment will follow an informed consent process approved by the responsible ethics committee. Peer-reviewed publication is planned to disseminate the study results.
BACKGROUND: NCT04207892.
摘要：
背景：由于缺乏高质量的临床证据，儿科患者长骨骨折和创伤性髋关节脱位的治疗存在管理争议和临床平衡。该方案描述了一项大型前瞻性全球多中心队列研究（注册表）的努力，旨在提供高质量的数据以协助循证治疗决策。
方法：符合资格的儿科患者（N=750-1000）患有肱骨近端骨折的开放性骨折，肱骨远端骨折,桡骨近端骨折,前臂干骨折,创伤性髋关节脱位,股骨颈骨折或胫骨干骨折将在24-36个月的时间内招募.住院和治疗细节（包括材料和植入物）将被捕获在基于云的，可搜索的数据库。成果措施包括射线照相评估，临床结果(如运动范围，肢体长度差异和植入物移除)，患者报告的结果(患者报告的骨折结果，患者报告的结果测量信息系统（PROMIS）和EuroQol-5D（EQ-5D-Y））和不良事件。除了患者人口统计学的描述性统计，基线特征，骨折类型和不良事件发生率，研究问题将根据数据的可用性和质量来制定。在进行统计分析之前，将准备统计分析计划。
背景：在每个参与中心招募患者之前，将获得伦理批准。患者登记将遵循由负责的伦理委员会批准的知情同意程序。同行评审的出版物计划传播研究结果。
背景：NCT04207892。
方法：符合资格的儿科患者（N=750-1000）患有肱骨近端骨折的开放性骨折，肱骨远端骨折,桡骨近端骨折,前臂干骨折,创伤性髋关节脱位,股骨颈骨折或胫骨干骨折将在24-36个月的时间内招募.住院和治疗细节（包括材料和植入物）将被捕获在基于云的，可搜索的数据库。成果措施包括射线照相评估，临床结果(如运动范围，肢体长度差异和植入物移除)，患者报告的结果(患者报告的骨折结果，患者报告的结果测量信息系统（PROMIS）和EuroQol-5D（EQ-5D-Y））和不良事件。除了患者人口统计学的描述性统计，基线特征，骨折类型和不良事件发生率，研究问题将根据数据的可用性和质量来制定。在进行统计分析之前，将准备统计分析计划。
背景：在每个参与中心招募患者之前，将获得伦理批准。患者登记将遵循由负责的伦理委员会批准的知情同意程序。同行评审的出版物计划传播研究结果。
背景：NCT04207892。
