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

10. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Pozorovací

Zápis (Odhadovaný)

100

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Tomasz Szczepanski, MD, PhD,
  • Telefonní číslo: +48784555436
  • E-mail: tszczepanski@4wsk.pl

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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)

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
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.
Diagnostický 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.
Diagnostický test: Intraoperative Computed Tomography (O-arm)
Intraoperative CT imaging performed during standard lumbar spine surgery to assess radiologic features of spinal instability.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Proportion of patients with lumbar spinal instability detected on intraoperative computed tomography (CT) versus preoperative imaging
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Časové okno
Correlation between intraoperative computed tomography (CT) radiologic parameters and preoperative clinical signs of instability
Časové okno: 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)
Časové okno: 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.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

4th Military Clinical Hospital with Polyclinic, Poland

Spolupracovníci

Medtronics, Inc.

Vyšetřovatelé

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

1. srpna 2027

Dokončení studie (Odhadovaný)

1. prosince 2027

Termíny zápisu do studia

První předloženo

28. května 2026

První předloženo, které splnilo kritéria kontroly kvality

10. června 2026

První zveřejněno (Aktuální)

12. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

10. června 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 11/BNBO/2026

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