跳至主要内容
临床试验/NCT05350319
NCT05350319已完成不适用

Prospective Comparison of Simulated Low Dose Computed Tomography to Conventional Dose Computed Tomography for the Evaluation of Glenoid Anatomy in Shoulder Arthroplasty

Duke University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Glenoid Version

研究概览

简要总结

This study is a prospective, departmental funded study examining the outcomes of simulated Low Dose CT scans compared to Conventional Dose CT scans in patients who present to Duke University for total shoulder arthroplasty or reverse shoulder arthroplasty.

详细描述

The purpose of this study is to compare the use of a conventional dose computed tomography scan (C-CT) to a simulated low dose computed tomography scan (L-CT) for preoperative planning in patients who are anticipated to undergo a total shoulder arthroplasty (TSA) or reverse shoulder arthroplasty (RSA) with the goal to reduce the radiation exposure to future patients undergoing preoperative planning. L-CT scans for analysis will be obtained prospectively as derived data from a C-CT scan performed on a dual source CT scanner. Briefly, a C-CT scan will be conducted, with scan images representing a reconstruction of simultaneous scans at two sensors. L-CT images will be derived from single source data (ie the scan data gathered by one of the emitters rather than a reconstruction from both). For additional validation, prospectively collected scans will be compared to retrospectively gathered scans of patients of similar demographics (age, sex, BMI) and degenerative changes who underwent a C-CT scan for an anticipated shoulder arthroplasty in the past. The reviewers will investigate the following outcome measures including 1) Are L-CT images of sufficient quality to be used for preoperative planning 2) Can accurate measurements including glenoid inclination, version, implant selection and humeral head subluxation be made on L-CT images 3) Do proposed treatment plans change with the use of L-CT relative to the chosen plans base on C-CT images. The investigators hypothesize L-CT images will be of sufficient image quality for diagnostic purposes, with similar measurements, and treatment outcomes.

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

入选标准

  • Subjects are planned to undergo total or reverse shoulder arthroplasty
  • Subject must be 18 years or older
  • Subjects who have capacity to give informed consent

排除标准

  • Subjects who are pregnant
  • Subjects under the age of 18
  • Subjects who do not have the capacity to give informed consent.

结局指标

主要结局

Glenoid Version

时间窗: Day 1

Representative CT images will be used to measure the version of each shoulder for preoperative purposes.

Low Dose CT Images of Sufficient Pre-operative Planning Quality

时间窗: Day 1

Low Dose CT Images will be compared to a standard dose to assess image quality.

Humeral Head Subluxation

时间窗: Day 1

Representative CT images will be used to measure the humeral head subluxation of each shoulder for preoperative purposes.

Glenoid Inclination

时间窗: Day 1

Representative CT images will be used to measure the inclination of each shoulder for preoperative purposes.

Implant Selection

时间窗: Day 1

Representative CT images will be used to determine the implant selection for preoperative purposes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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