RadiographyRRASPNCT07200557
Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery
An observational study of Radiography and Spinal Fusion, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiography, Spinal Fusion
- How many people
- 978 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing spinal fusion surgery (2011-2021) for degenerative conditions at University Hospitals Leuven
Who may be able to join
- 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
Who cannot join
- Non-degenerative (kypho) scoliosis
- Indications other than degenerative conditions and (adult) isthmic spondylolisthesis (e.g. tumor, septic arthritis, trauma,…)
- Chronic neuromuscular disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Radiography, Spinal Fusion
- Keywords
- Routine radiographs, Spinal fusion, Clinical utility, Spinal fusion surgery, Radiographs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Proportion of radiographs that led to further diagnostic tests or therapeutic interventions within 12 months post-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).
Measured: Within 12 months after spinal fusion surgery
Secondary outcomes (4)
Proportion of abnormal versus normal radiographs
Percentage of routine postoperative radiographs classified as abnormal compared to those classified as normal, based on radiologist or surgeon interpretation.
Measured: Within 12 months after spinal fusion surgery
Correlation between clinical course and management decisions
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.
Measured: Within 12 months after spinal fusion surgery
Correlation of demographic factors with radiographic utility
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).
Measured: Within 12 months after spinal fusion surgery
Correlation of surgical factors with radiographic utility
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).
Measured: Within 12 months after spinal fusion surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 May 2025
- Primary completion31 Aug 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiographyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 978 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sofie Rummens, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07200557
- Sponsor's protocol ID
- S68783
- Acronym
- RRASP
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reassessing the Role of Routine Radiographs After Spinal Fusion Surgery
- ClinicalTrials.gov ID
- NCT07200557
- Acronym / sponsor ID
- RRASP / S68783
- Conditions
- Radiography, Spinal Fusion
- Keywords
- Routine radiographs, Spinal fusion, Clinical utility, Spinal fusion surgery, Radiographs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 978 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Aug 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 1 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing spinal fusion surgery (2011-2021) for degenerative conditions at University Hospitals Leuven
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Non-degenerative (kypho) scoliosis
- Indications other than degenerative conditions and (adult) isthmic spondylolisthesis (e.g. tumor, septic arthritis, trauma,…)
- Chronic neuromuscular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
4 secondary outcomes
Proportion of abnormal versus normal radiographs
Time frame: Within 12 months after spinal fusion surgery
Correlation between clinical course and management decisions
Time frame: Within 12 months after spinal fusion surgery
Correlation of demographic factors with radiographic utility
Time frame: Within 12 months after spinal fusion surgery
Correlation of surgical factors with radiographic utility
Time frame: Within 12 months after spinal fusion surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofie Rummens, MD, PhD principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiography and Spinal Fusion, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2025.