Role of Intraoperative Computed Tomography in Assessment of Spine Instability in Lumbar Degenerative Disease (INSIGHT-CT)
Analysis of Intraoperative Computed Tomography Images in the Assessment of Radiological Features of Lumbar Spine Instability in Patients Undergoing Surgery for Degenerative Disease: Validation of Diagnostic Parameters
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Tomasz Szczepanski, MD, PhD,
- Número de teléfono: +48784555436
- Correo electrónico: tszczepanski@4wsk.pl
Ubicaciones de estudio
-
-
-
Wroclaw, Polonia, 50-981
- 4th Military Clinical Hospital with Polyclinic
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.
|
|
Prospective Cohort
Consecutively enrolled patients undergoing spine surgery with standardized intraoperative CT imaging performed during surgery.
|
Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of patients with lumbar spinal instability detected on intraoperative computed tomography (CT) versus preoperative imaging
Periodo de tiempo: 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.
|
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.
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Correlation between intraoperative computed tomography (CT) radiologic parameters and preoperative clinical signs of instability
Periodo de tiempo: 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.
|
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)
Periodo de tiempo: 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.
|
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.
|
Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Tomasz Szczepański, MD, PhD, 4th Military Clinical Hospital with Polyclinic, Wrocław, Poland
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 11/BNBO/2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .