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Surgical Treatment of Adjacent Segment Stenosis (STASS)

18. Juni 2026 aktualisiert von: Anton Früh, Charite University, Berlin, Germany

The goal of this clinical trial is to learn whether microdecompression alone is as effective as decompression with extension of fusion surgery in patients with symptomatic adjacent segment stenosis after previous lumbar fusion surgery.

The main questions it aims to answer are:

Is microdecompression alone non-inferior to decompression with extension of fusion in improving disability 24 months after surgery, as measured by the Oswestry Disability Index (ODI)? Does microdecompression alone result in similar or lower rates of complications, reoperations, pain, and radiological progression compared with decompression and fusion?

Researchers will compare microdecompression alone to decompression with extension of lumbar fusion to determine whether the less invasive procedure can achieve similar clinical outcomes while reducing surgical burden and preserving spinal structures.

Participants will:

Be randomly assigned to one of two treatment groups: microdecompression alone or decompression with extension of lumbar fusion.

Undergo the assigned surgical treatment. Attend clinical and radiological follow-up visits at 6, 12, and 24 months after surgery.

Complete questionnaires assessing disability, pain, quality of life, sleep quality, and mental health.

Undergo routine imaging and clinical examinations to evaluate treatment outcomes and possible complications.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

338

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienkontakt

Studienorte

  • Deutschland
    • State of Berlin
      • Berlin, State of Berlin, Deutschland, 10117
        • Charité - Universitätsmedizin Berlin

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

Beschreibung

Inclusion Criteria:

  • Age ≥18 years.
  • Oswestry Disability Index (ODI) between 30% and 80% at screening.
  • Symptomatic adjacent segment stenosis following degenerative lumbar fusion surgery.
  • Persistent symptoms despite at least 6 weeks of appropriate conservative treatment.
  • Radiological evidence of adjacent segment spinal stenosis on magnetic resonance imaging (MRI).
  • Ability to understand the study procedures and complete patient-reported outcome questionnaires.
  • Ability to provide written informed consent.

Exclusion Criteria:

  • Adjacent segment kyphosis or scoliosis greater than 10 degrees.
  • Screw loosening or pseudarthrosis of the previous fusion construct.
  • Known current pregnancy or breastfeeding.
  • Acute traumatic spinal injury or fracture.
  • Active inflammatory disease of the spine.
  • Active neoplastic disease of the spine.
  • Contraindication to spinal surgery.
  • Inability to provide informed consent or complete study questionnaires.
  • Symptoms attributable to spinal stenosis are not the predominant clinical complaint
  • Foraminal stenosis grade ≥2 according to the Lee classification.
  • Dynamic spondylolisthesis ≥3 mm on flexion-extension radiographs.
  • Persons involuntarily detained by judicial or administrative order.

Studienplan

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

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Control
Decompression and fusion
Verfahren: Microsurgical Decompression with Extension of Fusion
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
Aktiver Komparator: Intervention
Mircosurgical decompression only
Verfahren: Microsurgical Decompression Alone
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI)
Zeitfenster: 24 months after surgery
The primary endpoint is the proportion of participants achieving a reduction of at least 30% in the Oswestry Disability Index (ODI) compared with baseline. The ODI is a validated patient-reported outcome measure assessing disability related to lumbar spine disorders on a scale from 0% to 100%. A reduction of at least 30% is considered clinically meaningful.
24 months after surgery

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain related disability
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Disability related to low back pain assessed using the Oswestry Disability Index (ODI). The ODI score ranges from 0 to 100%, with higher scores indicating greater disability and worse functional impairment.
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Leg Pain Intensity at Rest
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for leg pain at rest.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Leg Pain Intensity during Movement
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for leg pain during movement.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Back Pain Intensity at Rest
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for back pain at rest.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Back Pain Intensity during Movement
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) for back pain during movement.The NRS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Maximum Walking Distance
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Maximum walking distance measured in meters.
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
generates eight domain scores (physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health), each transformed to a scale ranging from 0 to 100, with higher scores indicating better health-related quality of life and functional status. Unit of Measure: Points on a scale (0-100).
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L). The EQ-5D-5L evaluates five dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with five response levels. Responses are converted into a single EQ-5D-5L Index Score using an established country-specific value set. Higher index scores indicate better health-related quality of life. Unit of Measure: Utility index score (higher scores indicate better health-related quality of life).
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Mood Assessed by the German General Depression Scale - Short Form (ADS-K)
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Depressive symptoms assessed using the German General Depression Scale - Short Form (ADS-K). The ADS-K is a self-report questionnaire comprising 15 items, each rated on a 4-point Likert scale (0-3 points). Total scores range from 0 to 45 points, with higher scores indicating more severe depressive symptomatology and worse mood status. Unit of Measure: Points on a scale (range: 0-45; higher scores indicate more severe depressive symptoms)
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Zeitfenster: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-administered questionnaire evaluating sleep quality and disturbances over the previous month across seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Component scores are summed to generate a global PSQI score ranging from 0 to 21 points, with higher scores indicating poorer sleep quality and greater sleep disturbance. Unit of Measure: Points on a scale (range: 0-21; higher scores indicate worse sleep quality).
Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Length of hospital stay
Zeitfenster: From date of surgery until hospital discharge, up to 30 days postoperatively
Length of hospital stay measured in days from surgery until hospital discharge.
From date of surgery until hospital discharge, up to 30 days postoperatively
Intensive Care Unit Stay
Zeitfenster: From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.
Duration of intensive care unit stay measured in days.
From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.
Additional or Revision Spine Surgery
Zeitfenster: Up to 24 months after surgery
Proportion of participants requiring additional spinal surgery or revision surgery during follow-up.
Up to 24 months after surgery
Perioperative Complications
Zeitfenster: Perioperative/Periprocedural
Number and type of perioperative complications associated with the surgical procedure.
Perioperative/Periprocedural
Operative Parameters
Zeitfenster: Perioperative/Periprocedural
Operative duration, intraoperative blood loss
Perioperative/Periprocedural
Dynamic Spondylolisthesis
Zeitfenster: 24 month after surgery
Presence of dynamic spondylolisthesis defined as a translation of ≥3 mm on flexion-extension radiographs.Unit of Measure: Participants with dynamic spondylolisthesis.
24 month after surgery
Central Stenosis Severity Assessed by the Schizas Classification
Zeitfenster: 24 months after surgery
Central canal stenosis at the adjacent segment assessed on MRI using the Schizas classification (Grades A-D).Unit of Measure: Grade (A-D; higher grades indicate more severe stenosis).
24 months after surgery
Foraminal Stenosis Severity Assessed by the Lee Classification
Zeitfenster: 24 months after surgery.
Foraminal stenosis at the adjacent segment assessed on MRI using the Lee classification (Grades 1-4).Unit of Measure: Grade (1-4; higher grades indicate more severe foraminal stenosis).
24 months after surgery.
Implant Integrity
Zeitfenster: 24 months after surgery.
Implant integrity assessed on radiographs, including evidence of implant loosening, breakage, or material dislocation.Unit of Measure: Participants with implant failure.
24 months after surgery.
Segmental Lordosis
Zeitfenster: 24 months after surgery.
Segmental lordosis measured on standing lateral radiographs.Unit of Measure: Degrees (°).
24 months after surgery.

Mitarbeiter und Ermittler

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

Sponsor

Charite University, Berlin, Germany

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. Oktober 2026

Primärer Abschluss (Geschätzt)

30. September 2030

Studienabschluss (Geschätzt)

1. März 2031

Studienanmeldedaten

Zuerst eingereicht

29. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Juni 2026

Zuerst gepostet (Tatsächlich)

22. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

18. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • STASS-Trial
  • 574896382 (Andere Zuschuss-/Finanzierungsnummer: Deutsche Forschungsgemeinschaft (DFG))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Individual participant data underlying the results reported in publications arising from this study, after de-identification, will be made available upon reasonable request to the corresponding investigator.

Supporting documents including the study protocol, statistical analysis plan, and data dictionary will also be made available.

IPD-Sharing-Zeitrahmen

Beginning 12 months following publication of the primary study results and ending 5 years after publication.

IPD-Sharing-Zugriffskriterien

De-identified individual participant data (IPD) underlying the results reported in publications arising from this study, as well as the study protocol, statistical analysis plan, and analytic code, will be made available to qualified researchers.

Access will be granted to investigators who provide a scientifically sound research proposal that is approved by the study steering committee. Requests must be submitted to the study sponsor and should specify the intended use of the data.

Data will be shared only after publication of the primary study results and following execution of an appropriate data-sharing agreement. Access will be provided through a secure electronic data transfer system in accordance with applicable data protection regulations.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ANALYTIC_CODE

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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