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

10. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients with lumbar spinal instability detected on intraoperative computed tomography (CT) versus preoperative imaging
Zeitfenster: 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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Correlation between intraoperative computed tomography (CT) radiologic parameters and preoperative clinical signs of instability
Zeitfenster: 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)
Zeitfenster: 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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

4th Military Clinical Hospital with Polyclinic, Poland

Mitarbeiter

Medtronics, Inc.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. August 2026

Primärer Abschluss (Geschätzt)

1. August 2027

Studienabschluss (Geschätzt)

1. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

28. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 11/BNBO/2026

Plan für individuelle Teilnehmerdaten (IPD)

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UNENTSCHIEDEN

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