- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07200557
- Original Trial
Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery (RRASP)
Study Overview
Status
Conditions
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Leuven, Belgium
- UZ Leuven
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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
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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).
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Within 12 months after spinal fusion surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Proportion of abnormal versus normal radiographs
Time Frame: Within 12 months after spinal fusion surgery
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Percentage of routine postoperative radiographs classified as abnormal compared to those classified as normal, based on radiologist or surgeon interpretation.
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Within 12 months after spinal fusion surgery
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Correlation between clinical course and management decisions
Time Frame: Within 12 months after spinal fusion surgery
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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.
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Within 12 months after spinal fusion surgery
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Correlation of demographic factors with radiographic utility
Time Frame: Within 12 months after spinal fusion surgery
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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).
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Within 12 months after spinal fusion surgery
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Correlation of surgical factors with radiographic utility
Time Frame: Within 12 months after spinal fusion surgery
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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).
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Within 12 months after spinal fusion surgery
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Collaborators and Investigators
Investigators
- Principal Investigator: Sofie Rummens, MD, PhD, UZ Leuven
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- S68783
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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