Intraoperative Computed Tomography (O-arm): Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.
Study summary
This study examines how well computed tomography (CT) imaging performed during spine surgery - known as intraoperative CT - can detect instability in the lower (lumbar) part of the spine. Spinal instability means that the bones of the spine move more than they normally should, which can contribute to pain and may affect the outcome of surgery.
Before surgery, doctors usually check for this instability using X-rays taken while the patient bends forward and backward. These X-rays do not always show instability clearly. During surgery, the patient lies face down and the muscles are fully relaxed, which can change how the spine appears on imaging.
The purpose of this study is to learn whether CT images taken during surgery can identify signs of lumbar spinal instability as reliably as standard imaging performed before surgery, and whether they can reveal signs of instability that were not visible beforehand. To do this, the researchers will review imaging and clinical information from adults who are undergoing surgery for degenerative (wear-related) conditions of the lower spine.
This study does not change a patient's surgery or treatment. It only analyzes imaging and clinical information that are already part of standard care. The findings may help guide imaging and surgical decisions in lumbar spine surgery in the future.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adults aged 18 years or older
* Degenerative lumbar spine pathology requiring surgical treatment (e.g., degenerative spondylolisthesis, lumbar spinal stenosis, isthmic spondylolisthesis)
* Planned or performed lumbar decompression with instrumented fusion
* Available intraoperative computed tomography (CT) with comparative preoperative imaging (retrospective cohort), or intraoperative CT performed during the index surgery (prospective cohort)
* No prior surgery at the spinal level under evaluation; previous surgery at other levels permitted
* Stable general medical condition allowing planned clinical evaluation
* Written informed consent prior to participation (prospective cohort only)
Exclusion Criteria:
* Non-degenerative spinal pathology, including acute traumatic spinal injury, primary or metastatic spinal tumor, spinal infection (e.g., osteomyelitis, discitis), or inflammatory spinal disease (e.g., ankylosing spondylitis)
* Inadequate or incomplete imaging data, including poor-quality intraoperative CT or absence of comparative preoperative imaging
* Emergency or non-elective surgery
* Revision surgery involving the same spinal level(s)
* Inability to provide informed consent (prospective cohort only)
* Neuromuscular or congenital spinal deformity significantly altering spinal biomechanics (e.g., scoliosis \>20°, congenital segmentation anomalies)
Primary outcome measure(s)
Proportion of patients with lumbar spinal instability detected on intraoperative computed tomography (CT) versus preoperative imaging — Outcome assessment is performed at two pre-specified time points: preoperative imaging obtained within four weeks prior to surgery, and intraoperative computed tomography acquired during the index surgical procedure. This outcome measures how often each imaging modality identifies lumbar segmental instability. Preoperative imaging and intraoperative CT are each evaluated for pre-specified radiologic signs of instability by independent, blinded reviewers. For each modality, the proportion of patients in whom instability is detected is reported, and the difference between modalities is assessed as a non-inferiority comparison.
Trial sites (1)
Facility
City
Region
Status
4th Military Clinical Hospital with Polyclinic
Wroclaw
Poland
More 4th Military Clinical Hospital with Polyclinic, Poland trials in Poland
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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