Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery (RRASP)

September 26, 2025 updated by: Universitaire Ziekenhuizen KU Leuven
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.

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

978

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium
        • UZ Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing spinal fusion surgery (2011-2021) for degenerative conditions at University Hospitals Leuven

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients undergoing spinal fusion surgery (2011-2021) at University Hospitals Leuven
Retrospective cohort of adult patients (≥18 years) who underwent spinal fusion surgery for degenerative spinal conditions at University Hospitals Leuven between 2011 and 2021. Patients were followed for at least 12 months after surgery, with data collected from postoperative follow-up visits, including clinical course, radiographic findings, and subsequent management decisions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Within 12 months after spinal fusion surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within 12 months after spinal fusion surgery
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.
Within 12 months after spinal fusion surgery
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).
Within 12 months after spinal fusion surgery
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).
Within 12 months after spinal fusion surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sofie Rummens, MD, PhD, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

September 10, 2025

First Submitted That Met QC Criteria

September 26, 2025

First Posted (Estimated)

October 1, 2025

Study Record Updates

Last Update Posted (Estimated)

October 1, 2025

Last Update Submitted That Met QC Criteria

September 26, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This is a retrospective, single-center study. No individual participant data will be made publicly available. Summary results will be reported in peer-reviewed publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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