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Not yet recruiting NCT07661199

Surgical Treatment of Adjacent Segment Stenosis

No phase Interventional Adjacent Segment Disease Lumbar Spinal Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Microsurgical Decompression with Extension of Fusion, Microsurgical Decompression Alone.
Who it may be relevant to
Registry conditions: Adjacent Segment Disease, Lumbar Spinal Stenosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

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

Primary outcome measures

  • Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI) [Time frame: 24 months after surgery]
Secondary outcome measures (12)
  • Pain related disability [Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
  • Leg Pain Intensity at Rest [Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
  • Leg Pain Intensity during Movement [Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
  • Back Pain Intensity at Rest [Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
  • Back Pain Intensity during Movement [Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
  • Maximum Walking Distance [Time frame: 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) [Time frame: 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 [Time frame: 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) [Time frame: 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) [Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.]
  • Length of hospital stay [Time frame: From date of surgery until hospital discharge, up to 30 days postoperatively]
  • Intensive Care Unit Stay [Time frame: From admission to the intensive care unit after surgery until discharge from the intensive care unit, up to 30 days postoperatively.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Charité - Universitätsmedizin Berlin — Berlin

Identifiers

NCT: NCT07661199 · STASS-Trial · 574896382

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗