North American Scapula Consortium
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 170
- 主要终点
- Data Submission measured by total number of participating sites and patient enrollment
研究概览
简要总结
The North American Scapula Consortium (NASCon) is a multi-center injury specific outcomes registry.
There currently exists a paucity of outcomes data in the literature on this patient population. The NASCon registry will be a resource in which investigators can conduct adequately powered clinical outcomes research resulting in higher quality research with meaningful results, improved patient care, and evidence-based advancement for the treatment of scapula fractures. Registries can lead to significant discoveries in comparative effectiveness specifically in areas where randomized control studies are not possible. Collecting post-treatment (operative and non-operative) patient outcome data for similar injury patterns has been shown effective in uncovering optimal standards for treatment.
详细描述
Number of Subjects:
Estimated
Year 1 10 Sites 80 Subjects Enrolled
Year 2 13 Sites 130 Subjects Enrolled
Year 3 16 Sites 170 Subjects Enrolled
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥18 yrs of age
- •Operative and non-operative fractures meeting any one of the following criteria:
- •Extra - Articular fracture indication (one or more of the following): Glenopolar angle <30°, Medialization >1cm, and Angulation >30°
- •Intra-Articular fracture indication: >2mm
- •Patient signed consent
排除标准
- •Patients meeting operative criteria that are not able to understand the consent for research
结局指标
主要结局
Data Submission measured by total number of participating sites and patient enrollment
时间窗: Three years
Anticipated: Year 1 - 10 Sites,80 Subjects Enrolled Year 2 - 13 Sites, 130 Subjects Enrolled Year 3 - 16 Sites, 170 Subjects Enrolled
次要结局
- Optimization of data submission and data collected by statistician review of exported data collection(Biannual review (June 2017, Dec 2017, June 2018, Dec 2018, June 2019, Dec 2019-end date))
研究者
Peter A Cole, MD
Chair, Orthopaedic Dept., Regions Hospital; Professor, University of Minnesota
University of Minnesota