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Completed

NCT Number: NCT07200557

Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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).

Secondary outcomes

  1. Proportion of abnormal versus normal radiographs

    Time frame: Within 12 months after spinal fusion surgery

    Percentage of routine postoperative radiographs classified as abnormal compared to those classified as normal, based on radiologist or surgeon interpretation.

  2. Correlation between clinical course and management decisions

    Time frame: Within 12 months after spinal fusion surgery

    Percentage of follow-up visits in which the patient was symptomatic versus asymptomatic, compared to the percentage of those visits that resulted in further diagnostic testing or therapeutic intervention.

  3. Correlation of demographic factors with radiographic utility

    Time frame: Within 12 months after spinal fusion surgery

    Percentage of radiographs leading to additional diagnostic tests or therapeutic interventions, stratified by demographic variables (age in years, sex, body mass index in kg/m²).

  4. Correlation of surgical factors with radiographic utility

    Time frame: Within 12 months after spinal fusion surgery

    Percentage of radiographs leading to additional diagnostic tests or therapeutic interventions, stratified by surgical variables (fusion level: cervical, thoracic, lumbar; number of fused segments; type of instrumentation).

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: RRASP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 1, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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