Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT03562936 |
| Other study ID # |
2011/2034-2 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2014 |
| Est. completion date |
October 2029 |
Study information
| Verified date |
August 2021 |
| Source |
Haukeland University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The NORDSTEN- OS(Observational study) aim to study the natural course in patients with mild
to moderate symptomatic lumbar spinal stenosis with and without degenerative
spondylolisthesis. 10 years follow-up is planned.
The NORDSTEN-OS is one of three studies in The NORwegian Degenerative Spondylolisthesis and
Spinal STENosis studies.
The two other studies are:
NORDSTEN-SST (Spinal stenosis trial) (NCT02007083); a randomized controlled trial comparing
the clinical and radiological results in three different decompression techniques in patients
with lumbar spinal stenosis. The NORDSTEN-DS (Degenerative spondylolisthesis) (NCT02051374);
a randomized controlled trial comparing the outcome of surgery with decompression without
fixation and decompression with fixation in patients with lumbar spinal stenosis and
concurrent degenerative spondylolisthesis.
Description:
Objectives:
1. A longitudinal observation of clinical- and radiological development with 5- and 10
years follow-up. Variables predicting clinical deterioration or improvement, and outcome
measurements including time from inclusion to time for surgery, will be analyzed. We
will use predictive models appropriate to the type of data each prognostic outcome
measure represents. For example the repeated pain and disability measures will be
analysed using linear mixed models. Logistic regression models with no more than 1
variable per 10 events will be used to analyse associations between prognostic factors
and disability. Multivariate analysis will identify the predictive prognostic factors in
the demographic, physical, social and radiological domains. The number of factors that
will be entered in the multivariate analysis will be condensed by univariate pre-testing
and omitting highly correlated factors. The prognostic value of both single and combined
variables will be addressed by calculating sensitivity, specificity, positive and
negative likelihood ratios in a standard way.
Time to surgery will be modeled using Kaplan-Meier plot. Depending on number of treated
patients the effect of selected covariates on time to surgery will be evaluated using
the Cox model.
2. 1) To investigate differences between patients in the observational cohort and patients
treated surgically in NORDSTEN-SST and NORDSTEN-DS, by comparing baseline demographic-,
clinical-, and radiological data. Patients in the NORDSTEN-OS with lumbar spinal
stenosis and a verified degenerative spondylolisthesis of ≥ 3mm will be compared to
patients in the NORDSTEN-DS. Patients in the NORDSTEN-OS with lumbar spinal stenosis
without degenerative spondylolisthesis will be compared to patients in the NORDSTEN-SST.
We will use descriptive statistics to compare the patient groups. For each of the
variables we will compare measures of central tendency such as mean and median, and
measures of variability such as variance and quantiles. We will also plot distributions
of certain variables using histograms or fitted densities, in order to easier compare
and see similarities and differences between the groups.
Baseline data Demographical data: Age, gender, BMI, education and native language. Status
regarding: marriage, smoking, work and disability benefits.
Clinical data: duration of symptoms (back pain and leg pain) and use of analgetics, Patient
reported outcome measures: Oswestry Disability Index (ODI 2.0), Zurich Claudication
Questionnaire, EQ-5D and Numeric Rating Scale for leg pain and back pain. Hopkins symptom
check list (HSCL-25) HSCL-25 is a PROM for assessment of psychological variables. It covers
emotional distress, scores range from 1 to 4, with lower scores indicating less severe
symptoms.
Radiological data: Standing x-rays; anterior-posterior (AP), lateral and functional images
(lateral- extension and flexion) and MRI.
Radiological evaluations Standing x-ray with functional images and MRI will be performed at
baseline-, 5-, and 10 years follow-up. Additionally, patients with lumbar spinal stenosis and
concomitant degenerative spondylolisthesis at baseline undergo functional radiographs at 2
years follow-up. One musculoskeletal radiologist and two surgeons (Orthopedic surgeon and
Neurosurgeon) will perform the radiological interpretations using Picture Archiving and
Communication System (PACS), Sectra, Sweden.
MRI of the lumbar spine, including T1 and T2 sequences in the axial and sagittal planes. The
following variables will be measured:
Measurements quantifying the degree of stenosis:
Morphologic grading according to the method described by Schizas et al. The grading is based
on the cerebrospinal fluid/rootlet ratio, and is scaled from A-D, where A is no stenosis, B
moderate stenosis, C severe stenosis and D extreme stenosis.
Measurements from sagittal plane T1 MRI sequences for grading of foraminal stenosis using the
method of Lee et al.
The presence or absence of redundant nerve root sign.
Measurements when degenerative spondylolisthesis is present:
Measurement of the facet joint orientation will be done by MRI images in the transverse plan
using the method of Berleman et al.
Degree of disc degeneration according to Pfirrmann et al and Modic et al. Qualitative
measurement of facet joint fluid.
Qualitative measurement of disc height.
Skeletal x-rays:Standard images; frontal and lateral view of L1 to S1 in standing
position.Extension- and flexion images; lateral view of L1 to S1 with respectively maximal
flexion and maximal extension.
Measurement of lumbar lordosis (L1-S1),sacral slope Measurements from the radiographs for
calculating vertebral sagittal olisthesis and segmental instability will use the method of
Dupuis et al.
