NCT07200557

Brief 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. This retrospective cohort study evaluates the frequency and clinical impact of routine postoperative radiographs in patients undergoing spinal fusion surgery at University Hospitals Leuven.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
978

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

October 1, 2025

Completed
Last Updated

October 1, 2025

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

September 10, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

Routine radiographsSpinal fusionClinical utilitySpinal fusion surgeryRadiographs

Outcome Measures

Primary Outcomes (1)

  • 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).

    Within 12 months after spinal fusion surgery

Secondary Outcomes (4)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, Belgium

Location

Study Officials

  • Sofie Rummens, MD, PhD

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

October 1, 2025

Study Start

May 1, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

October 1, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

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.

Locations