Surgical Treatment of Adjacent Segment Stenosis (STASS)
18 de junho de 2026 atualizado 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.
Visão geral do estudo
Status
Ainda não está recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
338
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Anton Früh, PD MD M.Sc.
- Número de telefone: +49 030 450 660 376
- E-mail: anton.frueh@charite.de
Locais de estudo
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State of Berlin
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Berlin, State of Berlin, Alemanha, 10117
- Charité - Universitätsmedizin Berlin
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador Ativo: Control
Decompression and fusion
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Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
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Comparador Ativo: Intervention
Mircosurgical decompression only
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Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI)
Prazo: 24 months after surgery
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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.
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24 months after surgery
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pain related disability
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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.
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Leg Pain Intensity at Rest
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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.
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Leg Pain Intensity during Movement
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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.
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Back Pain Intensity at Rest
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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.
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Back Pain Intensity during Movement
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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.
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Maximum Walking Distance
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Maximum walking distance measured in meters.
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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).
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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).
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Mood Assessed by the German General Depression Scale - Short Form (ADS-K)
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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)
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)
Prazo: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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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).
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Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
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Length of hospital stay
Prazo: From date of surgery until hospital discharge, up to 30 days postoperatively
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Length of hospital stay measured in days from surgery until hospital discharge.
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From date of surgery until hospital discharge, up to 30 days postoperatively
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Intensive Care Unit Stay
Prazo: From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.
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Duration of intensive care unit stay measured in days.
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From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.
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Additional or Revision Spine Surgery
Prazo: Up to 24 months after surgery
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Proportion of participants requiring additional spinal surgery or revision surgery during follow-up.
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Up to 24 months after surgery
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Perioperative Complications
Prazo: Perioperative/Periprocedural
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Number and type of perioperative complications associated with the surgical procedure.
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Perioperative/Periprocedural
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Operative Parameters
Prazo: Perioperative/Periprocedural
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Operative duration, intraoperative blood loss
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Perioperative/Periprocedural
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Dynamic Spondylolisthesis
Prazo: 24 month after surgery
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Presence of dynamic spondylolisthesis defined as a translation of ≥3 mm on flexion-extension radiographs.Unit of Measure: Participants with dynamic spondylolisthesis.
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24 month after surgery
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Central Stenosis Severity Assessed by the Schizas Classification
Prazo: 24 months after surgery
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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).
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24 months after surgery
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Foraminal Stenosis Severity Assessed by the Lee Classification
Prazo: 24 months after surgery.
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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).
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24 months after surgery.
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Implant Integrity
Prazo: 24 months after surgery.
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Implant integrity assessed on radiographs, including evidence of implant loosening, breakage, or material dislocation.Unit of Measure: Participants with implant failure.
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24 months after surgery.
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Segmental Lordosis
Prazo: 24 months after surgery.
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Segmental lordosis measured on standing lateral radiographs.Unit of Measure: Degrees (°).
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24 months after surgery.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de outubro de 2026
Conclusão Primária (Estimado)
30 de setembro de 2030
Conclusão do estudo (Estimado)
1 de março de 2031
Datas de inscrição no estudo
Enviado pela primeira vez
29 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de junho de 2026
Primeira postagem (Real)
22 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- STASS-Trial
- 574896382 (Número de outro subsídio/financiamento: Deutsche Forschungsgemeinschaft (DFG))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano 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.
Prazo de Compartilhamento de IPD
Beginning 12 months following publication of the primary study results and ending 5 years after publication.
Critérios de acesso de compartilhamento 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 informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- ANALYTIC_CODE
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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