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.
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)
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)
Adults treated surgically for degenerative lumbar spine disease with instrumented fusion at a single spine surgery center. The population comprises two cohorts: a retrospective cohort of previously operated patients for whom intraoperative computed tomography (CT) and corresponding preoperative imaging are available in medical records, and a prospectively, consecutively enrolled cohort in whom intraoperative CT is acquired as part of the standard operative workflow. Both adult sexes are included; no upper age limit applies.
Cohort
Other
Intraoperative Computed Tomography (O-arm)
Diagnostic testIntraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.
Proportion of patients with lumbar spinal instability detected on intraoperative computed tomography (CT) versus preoperative imaging
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.
Correlation between intraoperative computed tomography (CT) radiologic parameters and preoperative clinical signs of instability
Proportion of patients with at least one instability feature detected only on intraoperative computed tomography (CT)
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4th Military Clinical Hospital with Polyclinic, Poland
Lead sponsor
Medtronics, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
