跳至主要内容
临床试验/NCT04117841
NCT04117841招募中不适用

SLIP Registry - SCFE Longitudinal International Prospective Registry

University of British Columbia1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2018年5月30日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kishore Mulpuri

Principal Investigator

University of British Columbia

研究点 (1)

Loading locations...

相似试验

SCFE Longitudinal International Prospective Registry | 临床试验