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| Name | Class |
|---|---|
| Medtronics, Inc. | INDUSTRY |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retrospective Cohort | Patients previously treated with minimally invasive transforaminal lumbar interbody fusion (MIS TLIF) surgery, with available intraoperative computed tomography (CT) and preoperative imaging data. |
| |
| Prospective Cohort | Consecutively enrolled patients undergoing spine surgery with standardized intraoperative CT imaging performed during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraoperative Computed Tomography (O-arm) | Diagnostic Test | Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomasz Szczepanski, MD, PhD, | Contact | +48784555436 | tszczepanski@4wsk.pl |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Szczepański, MD, PhD | 4th Military Clinical Hospital with Polyclinic, Wrocław, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4th Military Clinical Hospital with Polyclinic | Wroclaw | 50-981 | Poland |
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| 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. |
| ID | Term |
|---|---|
| D013130 | Spinal Stenosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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