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

NCT07644507 | Not Yet Recruiting

• 1 other identifier: 11/BNBO/2026
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Degenerative Lumbar Spine Diseases; Lumbar Spinal Instability; Degenerative Spondylolisthesis; Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

Study Arms (2)

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)

Prospective Cohort

Consecutively enrolled patients undergoing spine surgery with standardized intraoperative CT imaging performed during surgery.

Diagnostic Test: Intraoperative Computed Tomography (O-arm)

Interventions

Intraoperative Computed Tomography (O-arm) DIAGNOSTIC_TEST

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

Prospective Cohort; Retrospective Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• 4th Military Clinical Hospital with Polyclinic, Poland: lead
• Medtronics, Inc.: collaborator

Study Sites (1)

4th Military Clinical Hospital with Polyclinic

Wroclaw, 50-981, Poland

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Tomasz Szczepański, MD, PhD

  4th Military Clinical Hospital with Polyclinic, Wrocław, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomasz Szczepanski, MD, PhD,

CONTACT

+48784555436; tszczepanski@4wsk.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-05

Locations

PL (1)