Skip to content

Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)

Degenerative Segmental Instability in Lumbar Spinal Stenosis Patients - Study on Instability, Clinical Outcomes, Reoperation Rate With a 2 Year Follow up

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04406987
Enrollment
235
Registered
2020-05-29
Start date
2021-06-30
Completion date
2021-12-10
Last updated
2021-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis

Keywords

instability, anterior translation, slip, segmental motion, radiologic assesment, lumbar MRI, MRI characteristics

Brief summary

Age related changes in the lumbar spine can lead to narrowing of the spinal canal (spinal stenosis) causing leg and back pain. Spinal stenosis can be associated with a misalignment of the spine caused by forward slippage of a vertebrae over another. This instability is diagnosed using diagnostic imaging. With signs of instability the spine surgeon might choose a fusion of the vertebrae. This is a more complex procedure in relation to the simple decompression preformed without instability for spinal stenosis. The purpose of this study is to identify characteristics of instability of the lumbar spine on diagnostic imaging, and investigate associations with surgical data and patient reported outcomes from the National Spine databases from Denmark and Sweden. This will support spine surgeons in providing evidence-based surgical treatment for spinal stenosis with or without signs of instability

Detailed description

A multicenter retrospective cohort study of prospectively collected data from national spine surgery databases in Denmark and Sweden. This project is a collaboration between sector for spine surgery and research Middelfart Hospital and spine surgeons at Orebro Hospital and Lund Hospital in Sweden. Data subtracted from Danish national spine surgery database, DaneSpine, from Middelfart Hospital, and Swedish Spinal Register, SweSpine, from hospitals in Malmö, Lund, Trelleborg and Karlskroga. Both databases are clinical quality databases with a high response-rate. DaneSpine is administered by Danish Society of Spine Surgeons and is managed by secretary of DaneSpine. SweSpine is administered by Swedish Society of Spinal Surgeons and managed Patients are invited to register when scheduled for surgery. Patients signs informed consent and receives follow-up questionaires 3 and 6 months, one, two, 5 and 10 years post-surgery. Questionaires are validated PROM (patient reported outcome measures) and PREM (patient reported experience measures). The surgeon is responsible for registering surgical data, including complications and reoperations. Data relevant for present study will be applied for at the respective societies and managed and stored in compliance with General Data Protection Regulation. The EasyWiz software (Medical Insight, Chicago, IL, USA) is used for analysis of all MRIs and radiographs. All imaging will be analyzed by 2 independent examiners. The interobserver reliability will be calculated. Missing data such as variables reported as missing or non-reported will not be included in statistical analysis. Statistics: significance of difference in mean values between groups for continuous normally distributed data unpaired t-test. Categorical variables normally distributed: Chi-squared/Fishers exact test. Multivariable regression analysis. Kappa statistics for interobserver reliability presented in the article.

Interventions

PROCEDUREdecompression

surgical technique for neural decompression varied based on surgeon's preference, but always with preservation for spinous processes. Either open with or without microscope or using tubular retractors.

PROCEDUREfusion

fusion techniques consisted besides decompression of additional implantation of pedicle screws with rods, with or without intervertebral fusion and cage(s). Non-instrumented technique with allograft bone. Fusion technique on surgeon's discretion.

Sponsors

Spine Centre of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years

Inclusion criteria

\- MRI verified spinal stenosis patients with or with out degenerative spondylolisthesis (\> 3mm anterior translation in lumbar MRI), who underwent surgery at L4/L5 level with either decompression alone or decompression with fusion between 2010 and 2017. Included ICD-10 diagnostic groups DM480 and DM431. Must have standing lateral radiographs preoperatively. Completed 2 year follow up.

Exclusion criteria

* previous surgery at the same level, * malignancy or undergoing treatment for malignancy * scoliosis Cobb angel \>20 degrees

Design outcomes

Primary

MeasureTime frameDescription
facet joint gappre-surgeryMRI proxies 1

Secondary

MeasureTime frameDescription
facet angelpre-surgeryMRI proxies 2
disc heightpre-surgeryMRI proxies 3
anterior translationpre-surgeryMRI proxies 4
intradiscal vacuumpre-surgeryMRI proxies 5
radiographic slippre-surgeryanterior translation on lateral radiograph

Other

MeasureTime frameDescription
VAS legpre-surgery and 3 months, 12 months and 2 years post-surgeryVisual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale
complicationduring surgery or during admissionperisurgical complication within admission.
VAS backpre-surgery and 3 months, 12 months and 2 years post-surgeryVisual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale
EQ-5Dpre-surgery and 3 months, 12 months and 2 years post-surgeryEuroQol (EQ-5D) measures health-related quality of life on a scale where 0.0 equal's death and 1.0 equals perfect health
ODIpre-surgery and 3 months, 12 months and 2 years post-surgeryOswestry Disability Index (ODI) questionnaire scores range from 0 (no disability) to 100 (total disability)
patient characteristicspre-surgery and 3 months, 12 months and 2 years post-surgeryage, gender, BMI, smoking, diabetes
reoperation3 months, 12 months and 2 years post-surgeryoperation on index level after primary operation and discharge within follow-up period

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026