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临床试验/NCT02399319
NCT02399319终止不适用

Prospective Randomized Comparison of Subcutaneous Internal Fixation ("INFIX") and Plating for Pelvic Ring Injuries With Symphysis Disruptions

Indiana University2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2014年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
4
试验地点
2
主要终点
Functional Outcomes

研究概览

简要总结

The purpose of this study is to compare subcutaneous internal fixation and open plating of the symphysis in patients with a disruption of the symphysis requiring stabilization.

详细描述

The aim of this study is to determine whether either one of the two procedures has significant advantages over the other. The null hypothesis of this study is that there is no difference between plating and subcutaneous internal fixation of symphysis disruptions with respect to primary and secondary outcomes. The study is a randomized trial with patients who sustained a symphysis disruption who will randomize to either closed reduction and subcutaneous internal fixation, or open reduction and plating of the symphysis. There will also be two observational arms of the study, patients who do not agree to randomization and will receive internal fixation according to the treating surgeon's discretion and patients with a symphysis disruption that do not require any form of anterior pelvic internal fixation based on the treating surgeon's opinion. Clinical assessments will occur at the time of hospital admission and at all post-operative follow-up intervals (2 weeks, 6 weeks, 3 months, 6months, 12 months, and 24 months).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A symphysis disruption either in the coronal and/or sagittal plane on anterior-posterior , inlet and/or outlet pelvic radiographs
  • Need for anterior pelvic ring stabilization
  • Injury amenable to plating as well as subcutaneous internal fixation per the treating surgeon's opinion
  • Patient was ambulatory prior to sustaining the injury
  • Provision of informed consent by patient or proxy

排除标准

  • Patients with a slim build with little subcutaneous fat who cannot be treated with a subcutaneous internal fixator based on the treating surgeon's opinion
  • Patients who are deemed not likely to follow-up (e.g. patients who live more than 50 miles away and patients with no fixed address)
  • Moderately or severely cognitively impaired patients
  • Pregnant women
  • Prisoners

结局指标

主要结局

Functional Outcomes

时间窗: 24 hours - 24 months

The primary objective is to compare functional outcomes between subcutaneous internal fixation and symphyseal plating as measured by the PROMIS v1.2-Physical Function instrument.

次要结局

  • Compare the health-related quality of life and functional outcome scores(24 hours - 24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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