SLIP Registry - SCFE Longitudinal International Prospective Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE
研究概览
简要总结
Slipped Capital Femoral Epiphysis (SCFE) is the most common disorder of the adolescent hip and diagnosis and treatment of SCFE remain areas of controversy and investigation. The current issues relating to diagnosis stem from an inability to diagnose the condition early on, resulting in increased morbidity. Once diagnosed, there are multiple different options for surgical treatment, including in-situ pinning, and the Modified Dunn procedure. Research is ongoing to determine the parameters that should be considered when selecting a procedure to ensure an ideal outcome. In particular, there is a focus on investigating which treatment method may result in lower incidence of avascular necrosis of the femoral head and femoroacetabular impingement (FAI), two significant long term concerns associated with SCFE. Despite myriad published studies on SCFE, very few are prospective and most lack sufficient patient numbers for clinically meaningful comparative analysis. The aim of this study is to develop a multi-center, international prospective registry of patients with SCFE to facilitate the comprehensive examination of clinical, functional and radiographic outcomes of each treatment, in relation to specific parameters determined prior to intervention. The general registry will serve as a hypothesis-generating database of prospectively collected outcomes. In turn, this will facilitate the development of targeted, hypothesis-testing randomized controlled trials and observational studies that can be housed within the larger registry.
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
- 0 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of SCFE
- •Intend to receiving follow-up at participating centre
- •Less than 18 years old at time of admission
- •Adequate diagnostic information and radiographic imaging (for patients previously treated for SCFE)
排除标准
- •No definitive diagnosis of SCFE
- •Do not intend to receive follow-up at a participating centre
- •Greater than 18 years old at time of admission
- •Prior treatment for SCFE not appropriately documented
- •Known or suspected underlying conditions (e.g., cerebral palsy, spina bifida, or osteogenesis imperfecta)
结局指标
主要结局
Examination of timelines and results of diagnostic tests leading to the diagnosis of SCFE
时间窗: Until study completion in 2028
Development of a multi-centre, general, prospective SCFE registry, with follow-up to skeletal maturity
时间窗: Until study completion in 2028
Determination of whether prophylactic fixation allows for preservation of hip morphology and function in the short and long term
时间窗: Until study completion in 2028
Determination of the timeline for patients to return to full weight-bearing following treatment and to assess the level to which they return to activity
时间窗: Until study completion in 2028
Comparison of the clinical, functional, and radiographic parameters related to SCFE in the context of treatment outcomes
时间窗: Until study completion in 2028
Comparative analysis of surgical treatment outcomes, with particular regard to complications (avascular necrosis, femoroacetabular impingement (FAI), secondary surgeries)
时间窗: Until study completion in 2028
Examination of the long-term outcome of prophylactically pinning the contralateral hip, specifically in regards to development of avascular necrosis
时间窗: Until study completion in 2028
Comparison of mild SCFE treatment with or without acute FAI treatment in regard to complication and short-term outcomes
时间窗: Until study completion in 2028
次要结局
未报告次要终点
研究者
Kishore Mulpuri
Principal Investigator
University of British Columbia
