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Role of Intraoperative Computed Tomography in Assessment of Spine Instability in Lumbar Degenerative Disease (INSIGHT-CT)

10. juni 2026 opdateret af: 4th Military Clinical Hospital with Polyclinic, Poland

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk 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.
Diagnostisk test: Intraoperative Computed Tomography (O-arm)
Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of patients with lumbar spinal instability detected on intraoperative computed tomography (CT) versus preoperative imaging
Tidsramme: 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.

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

4th Military Clinical Hospital with Polyclinic, Poland

Samarbejdspartnere

Medtronics, Inc.

Efterforskere

  • Ledende efterforsker: Tomasz Szczepański, MD, PhD, 4th Military Clinical Hospital with Polyclinic, Wrocław, Poland

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

28. maj 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

12. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 11/BNBO/2026

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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Kliniske forsøg med Intraoperative Computed Tomography (O-arm)

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