Surgical Treatment of Adjacent Segment Stenosis (STASS)
18 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Tipo de estudio
Intervencionista
Inscripción (Estimado)
338
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Anton Früh, PD MD M.Sc.
- Número de teléfono: +49 030 450 660 376
- Correo electrónico: anton.frueh@charite.de
Ubicaciones de estudio
-
-
State of Berlin
-
Berlin, State of Berlin, Alemania, 10117
- Charité - Universitätsmedizin Berlin
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Control
Decompression and fusion
|
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
|
|
Comparador activo: Intervention
Mircosurgical decompression only
|
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI)
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Pain related disability
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Perioperative/Periprocedural
|
Number and type of perioperative complications associated with the surgical procedure.
|
Perioperative/Periprocedural
|
|
Operative Parameters
Periodo de tiempo: Perioperative/Periprocedural
|
Operative duration, intraoperative blood loss
|
Perioperative/Periprocedural
|
|
Dynamic Spondylolisthesis
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 24 months after surgery.
|
Segmental lordosis measured on standing lateral radiographs.Unit of Measure: Degrees (°).
|
24 months after surgery.
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
30 de septiembre de 2030
Finalización del estudio (Estimado)
1 de marzo de 2031
Fechas de registro del estudio
Enviado por primera vez
29 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
18 de junio de 2026
Publicado por primera vez (Actual)
22 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
22 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
18 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- STASS-Trial
- 574896382 (Otro número de subvención/financiamiento: Deutsche Forschungsgemeinschaft (DFG))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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.
Marco de tiempo para compartir IPD
Beginning 12 months following publication of the primary study results and ending 5 years after publication.
Criterios de acceso compartido de 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.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .