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NCT Number: NCT07644507

Role of Intraoperative Computed Tomography in Assessment of Spine Instability in Lumbar Degenerative Disease

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.

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Key information

Conditions

Degenerative Lumbar Spine Diseases Bone Diseases Degenerative Spondylolisthesis Lumbar Spinal Instability Lumbar Spinal Stenosis Musculoskeletal Diseases Spinal Diseases Spinal Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

4th Military Clinical Hospital with Polyclinic

Wroclaw, 50-981, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intraoperative Computed Tomography (O-arm)

Diagnostic Test

Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.

Primary outcomes

  1. Proportion of patients with lumbar spinal instability detected on intraoperative computed tomography (CT) versus preoperative imaging

    Time frame: 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 outcomes

  1. Correlation between intraoperative computed tomography (CT) radiologic parameters and preoperative clinical signs of instability

    Time frame: 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.

  2. Proportion of patients with at least one instability feature detected only on intraoperative computed tomography (CT)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tomasz Szczepanski, MD, PhD,

CONTACT

[email protected]

+48784555436

Sponsors and collaborators

Lead sponsor

4th Military Clinical Hospital with Polyclinic, Poland

Other

Collaborators

  • Medtronics, Inc.

Registry information

Official study title

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

Acronym: INSIGHT-CT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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