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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
338
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany
Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI)
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.
Time frame: 24 months after surgery
Pain related disability
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.
Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Leg Pain Intensity at Rest
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.
Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Leg Pain Intensity during Movement
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.
Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Back Pain Intensity at Rest
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.
Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Back Pain Intensity during Movement
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.
Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Maximum Walking Distance
Maximum walking distance measured in meters.
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)
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).
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
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).
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)
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)
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)
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).
Time frame: Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery.
Length of hospital stay
Length of hospital stay measured in days from surgery until hospital discharge.
Time frame: From date of surgery until hospital discharge, up to 30 days postoperatively
Intensive Care Unit Stay
Duration of intensive care unit stay measured in days.
Time frame: 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
Proportion of participants requiring additional spinal surgery or revision surgery during follow-up.
Time frame: Up to 24 months after surgery
Perioperative Complications
Number and type of perioperative complications associated with the surgical procedure.
Time frame: Perioperative/Periprocedural
Operative Parameters
Operative duration, intraoperative blood loss
Time frame: Perioperative/Periprocedural
Dynamic Spondylolisthesis
Presence of dynamic spondylolisthesis defined as a translation of ≥3 mm on flexion-extension radiographs.Unit of Measure: Participants with dynamic spondylolisthesis.
Time frame: 24 month after surgery
Central Stenosis Severity Assessed by the Schizas Classification
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).
Time frame: 24 months after surgery
Foraminal Stenosis Severity Assessed by the Lee Classification
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).
Time frame: 24 months after surgery.
Implant Integrity
Implant integrity assessed on radiographs, including evidence of implant loosening, breakage, or material dislocation.Unit of Measure: Participants with implant failure.
Time frame: 24 months after surgery.
Segmental Lordosis
Segmental lordosis measured on standing lateral radiographs.Unit of Measure: Degrees (°).
Time frame: 24 months after surgery.
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