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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lumbar Spinal Stenosis; Degenerative Spondylolisthesis; Lumbar Spinal Instability; Degenerative Lumbar Spine Diseases
• Intervention / Treatment: Diagnostic test: Intraoperative Computed Tomography (O-arm)

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Tomasz Szczepanski, MD, PhD,; Phone Number: +48784555436; Email: tszczepanski@4wsk.pl

Study Locations

• Poland
  • Wroclaw, Poland, 50-981
    • 4th Military Clinical Hospital with Polyclinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Intraoperative Computed Tomography (O-arm); 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.	Diagnostic test: Intraoperative Computed Tomography (O-arm); Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome 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.

Collaborators and Investigators

• Sponsor: 4th Military Clinical Hospital with Polyclinic, Poland
• Collaborators: Medtronics, Inc.
• Investigators: Principal Investigator: Tomasz Szczepański, MD, PhD, 4th Military Clinical Hospital with Polyclinic, Wrocław, Poland

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: May 28, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis
• Other Study ID Numbers: 11/BNBO/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED