Degenerative Lumbar Spine Diseases, Degenerative Spondylolisthesis, Lumbar Spinal Instability, Lumbar Spinal Stenosis
Conditions
Brief 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.
Detailed description
This single-center observational cohort study evaluates the diagnostic performance of intraoperative computed tomography (O-arm) in characterizing radiologic features of lumbar segmental instability in patients treated surgically for degenerative spinal disease. Both retrospective and prospectively enrolled participants are included; in the latter, acquisition is embedded in the routine operative workflow, with no procedure added beyond established care. Image assessment is carried out by independent, blinded reviewers applying a predefined, standardized evaluation framework. Eligibility, endpoints, and the analytic approach are specified in the corresponding sections of this record, while operational parameter definitions are retained in the study protocol.
Interventions
DIAGNOSTIC_TESTIntraoperative Computed Tomography (O-arm)
Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.
Sponsors
4th Military Clinical Hospital with Polyclinic, Poland
Medtronics, Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between intraoperative computed tomography (CT) radiologic parameters and preoperative clinical signs of instability | Outcome assessment is performed at two pre-specified time points: clinical examination conducted at the preoperative baseline visit, and intraoperative computed tomography acquired during the index surgical procedure. |
| Proportion of patients with at least one instability feature detected only on intraoperative computed tomography (CT) | 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. |
Countries
Poland
Contacts
CONTACTTomasz Szczepanski, MD, PhD,
PRINCIPAL_INVESTIGATORTomasz Szczepański, MD, PhD
4th Military Clinical Hospital with Polyclinic, Wrocław, Poland
Outcome results
None listed