Adjacent Segment Stenosis M48.06
Conditions
Interventions
Group 1: Fusion and Decompression (Control)
Group 2: Decompression only (Intervention)
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age = 18 years - Oswestry Disability Index (ODI) at screening 30–80% (ODI = 30% and ODI = 80%) - Symptomatic adjacent segment stenosis following degenerative lumbar fusion surgery that has not responded to at least 6 weeks of qualified conservative treatment - MRI evidence of spinal canal stenosis at the adjacent segment following lumbar fusion surgery - Capacity to provide informed consent and ability to complete the questionnaires - Written informed consent after comprehensive patient information and counseling
Exclusion criteria
Exclusion criteria: - Adjacent segment kyphosis or scoliosis (>10°) - Screw loosening / pseudarthrosis - Known current pregnancy or breastfeeding - Acute traumatic injury or fracture of the spine - Active inflammatory or neoplastic disease of the spine - Contraindication to spinal surgery - Inability to provide complete and comprehensible informed consent due to language barriers, even with the assistance of an interpreter (as the questionnaires used in the study have been validated in the German language only) - Symptoms related to spinal canal stenosis are not the patient’s leading clinical symptom - Neuroforaminal stenosis grade = 2 according to Lee et al. (Lee S, Lee JW, Yeom JS, et al. A practical MRI grading system for lumbar foraminal stenosis. AJR Am J Roentgenol. Apr 2010;194(4):1095–1098. doi:10.2214/AJR.09.2772) - Dynamic spondylolisthesis = 3 mm on flexion-extension radiographs - Persons institutionalized by judicial or governmental order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with a reduction in the Oswestry Disability Index (ODI) of =30% two years after surgery (dichotomous endpoint: yes/no). The ODI is a validated patient-reported questionnaire consisting of 10 sections (total scale 0–100%) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Proportion of participants requiring an additional spinal procedure - Numeric Rating Scale (NRS) for back and leg pain at rest and during movement (0–10) - SF-36 and EQ-5D-5L health-related quality of life questionnaires - Pittsburgh Sleep Quality Index (PSQI) - Allgemeine Depressionsskala – Short Form (ADS-K) - Maximum walking distance (meters) - Number of revision/reoperation procedures - Number of perioperative complications - Duration of surgery (minutes) - Intraoperative blood loss (mL) - Length of hospital stay and duration of intensive care unit stay (days) - MRI parameters: Schizas classification of central stenosis, Lee classification of foraminal stenosis, sagittal and axial spinal canal diameter - Flexion-extension radiographs: new dynamic spondylolisthesis = 3 mm - Conventional radiographs: implant dislocation (yes/no), segmental alignment, segmental lordosis (degrees) | — |
Countries
Austria, Germany
Contacts
Public ContactAnton Früh
Klinik für Neurochirurgie - Charité Universitätsmedizin Berlin
Outcome results
None listed