Surgical Treatment of Adjacent Segment Stenosis

Обзор

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.

Вмешательства

• Процедура Microsurgical Decompression with Extension of Fusion
  Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
• Процедура Microsurgical Decompression Alone
  Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.

Первичные конечные точки

• Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI) [Срок оценки: 24 months after surgery]

Вторичные конечные точки (12)

• Pain related disability [Срок оценки: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
• Leg Pain Intensity at Rest [Срок оценки: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
• Leg Pain Intensity during Movement [Срок оценки: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
• Back Pain Intensity at Rest [Срок оценки: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
• Back Pain Intensity during Movement [Срок оценки: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
• Maximum Walking Distance [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
• Length of hospital stay [Срок оценки: From date of surgery until hospital discharge, up to 30 days postoperatively]
• Intensive Care Unit Stay [Срок оценки: From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Charité - Universitätsmedizin Berlin — Berlin

Идентификаторы

NCT: NCT07661199 · STASS-Trial · 574896382

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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