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临床试验/NCT07200557
NCT07200557已完成不适用

Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 978 人开始时间: 2025年5月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
978
试验地点
1
主要终点
Proportion of radiographs that led to further diagnostic tests or therapeutic interventions within 12 months post-surgery

研究概览

简要总结

Routine radiographs are commonly obtained after spinal fusion surgery to monitor postoperative evolution and detect complications. However, the actual contribution of these radiographs to clinical decision-making remains unclear. This retrospective cohort study evaluates the frequency and clinical impact of routine postoperative radiographs in patients undergoing spinal fusion surgery at University Hospitals Leuven.

详细描述

Routine radiographs are commonly obtained after spinal fusion surgery to assess implant position, fusion progress, and potential complications. Yet, their actual contribution to patient care remains uncertain, and routine use may expose patients to unnecessary radiation and increase healthcare costs.

In this retrospective cohort study, the investigators will evaluate the clinical utility of routine radiographs during the first postoperative year after spinal fusion surgery at University Hospitals Leuven (2011-2021).

The investigators will review each follow-up visit to record the clinical course, radiographic findings, and whether these influenced further diagnostic tests or therapeutic interventions.

The investigators will primarily assess how often radiographs lead to a change in management. Secondary analyses will determine the proportion of abnormal versus normal radiographs, the relationship between clinical course and imaging results, and whether demographic or surgical factors predict radiographic utility.

By analyzing nearly 1,000 patients and more than 2,800 visits, the investigators will provide one of the most comprehensive evaluations of routine postoperative radiographs to date, aiming to guide more efficient, evidence-based follow-up strategies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Retrospective

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

  • Patients who underwent spinal fusion surgery at UZ Leuven, including the cervical, thoracic and lumbar spine for a degenerative condition
  • Adults of 18 years and older
  • Follow up at least 3 months after surgery

排除标准

  • Non-degenerative (kypho) scoliosis
  • Indications other than degenerative conditions and (adult) isthmic spondylolisthesis (e.g. tumor, septic arthritis, trauma,…)
  • Chronic neuromuscular disease

结局指标

主要结局

Proportion of radiographs that led to further diagnostic tests or therapeutic interventions within 12 months post-surgery

时间窗: Within 12 months after spinal fusion surgery

Percentage of follow-up visits with routine radiographs in which the radiograph resulted in further diagnostic testing (e.g., CT, MRI) or a therapeutic intervention (e.g., medication change, reoperation).

次要结局

  • Proportion of abnormal versus normal radiographs(Within 12 months after spinal fusion surgery)
  • Correlation between clinical course and management decisions(Within 12 months after spinal fusion surgery)
  • Correlation of demographic factors with radiographic utility(Within 12 months after spinal fusion surgery)
  • Correlation of surgical factors with radiographic utility(Within 12 months after spinal fusion surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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