Adjacent Segment Disease, Lumbar Spinal Stenosis
Conditions
Keywords
Adjacent Segment Disease, Adjacent Segment Stenosis, Lumbar Spinal Stenosis
Brief summary
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
PROCEDUREMicrosurgical Decompression with Extension of Fusion
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis combined with extension of the existing lumbar fusion.
PROCEDUREMicrosurgical Decompression Alone
Participants undergo microsurgical decompression of symptomatic adjacent segment stenosis after previous lumbar fusion surgery without extension of the existing fusion.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Achieving at Least 30% Reduction in Oswestry Disability Index (ODI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain related disability | 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. |
| Leg Pain Intensity at Rest | 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. |
| Leg Pain Intensity during Movement | 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. |
| Back Pain Intensity at Rest | 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. |
| Back Pain Intensity during Movement | 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. |
| Maximum Walking Distance | Baseline (before surgery), 6 months after surgery, 12 months after surgery, and 24 months after surgery. | Maximum walking distance measured in meters. |
| Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36) | 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). |
| Health-Related Quality of Life Assessed by the EuroQol 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Index Score | 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). |
| Mood Assessed by the German General Depression Scale - Short Form (ADS-K) | 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) |
| Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI) | 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). |
| Length of hospital stay | From date of surgery until hospital discharge, up to 30 days postoperatively | Length of hospital stay measured in days from surgery until hospital discharge. |
| Intensive Care Unit Stay | 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. |
| Additional or Revision Spine Surgery | Up to 24 months after surgery | Proportion of participants requiring additional spinal surgery or revision surgery during follow-up. |
| Perioperative Complications | Perioperative/Periprocedural | Number and type of perioperative complications associated with the surgical procedure. |
| Operative Parameters | Perioperative/Periprocedural | Operative duration, intraoperative blood loss |
| Dynamic Spondylolisthesis | 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. |
| Central Stenosis Severity Assessed by the Schizas Classification | 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). |
| Foraminal Stenosis Severity Assessed by the Lee Classification | 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). |
| Implant Integrity | 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. |
| Segmental Lordosis | 24 months after surgery. | Segmental lordosis measured on standing lateral radiographs.Unit of Measure: Degrees (°). |
Countries
Germany
Contacts
CONTACTAnton Früh, PD MD M.Sc.
Outcome results
None listed