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Surgical Treatment of Adjacent Segment Stenosis (STASS)

18 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Estimé)

338

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: Control
Decompression and fusion
Procédure: Microsurgical Decompression with Extension of Fusion
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
Comparateur actif: Intervention
Mircosurgical decompression only
Procédure: Microsurgical Decompression Alone
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Pain related disability
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Perioperative/Periprocedural
Number and type of perioperative complications associated with the surgical procedure.
Perioperative/Periprocedural
Operative Parameters
Délai: Perioperative/Periprocedural
Operative duration, intraoperative blood loss
Perioperative/Periprocedural
Dynamic Spondylolisthesis
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 24 months after surgery.
Segmental lordosis measured on standing lateral radiographs.Unit of Measure: Degrees (°).
24 months after surgery.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Charite University, Berlin, Germany

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 octobre 2026

Achèvement primaire (Estimé)

30 septembre 2030

Achèvement de l'étude (Estimé)

1 mars 2031

Dates d'inscription aux études

Première soumission

29 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 juin 2026

Première publication (Réel)

22 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 juin 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • STASS-Trial
  • 574896382 (Autre subvention/numéro de financement: Deutsche Forschungsgemeinschaft (DFG))

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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

Critères d'accès au partage IPD

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.

Type d'informations de prise en charge du partage d'IPD

  • PROTOCOLE D'ÉTUDE
  • SÈVE
  • ANALYTIC_CODE

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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