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NCT Number: NCT04406987

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

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

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Key information

Conditions

Degenerative Lumbar Spinal Stenosis Degenerative Spondylolisthesis

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Center for spine surgery and research, Spine Center of Southern Denmark

Middelfart, 5500, Denmark

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decompression

Procedure

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.

Fusion

Procedure

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.

Other names: arthrodese

Primary outcomes

  1. facet joint gap

    Time frame: pre-surgery

    MRI proxies 1

Secondary outcomes

  1. facet angel

    Time frame: pre-surgery

    MRI proxies 2

  2. disc height

    Time frame: pre-surgery

    MRI proxies 3

  3. anterior translation

    Time frame: pre-surgery

    MRI proxies 4

  4. intradiscal vacuum

    Time frame: pre-surgery

    MRI proxies 5

  5. radiographic slip

    Time frame: pre-surgery

    anterior translation on lateral radiograph

Other outcomes

  1. VAS leg

    Time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery

    Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale

  2. VAS back

    Time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery

    Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale

  3. EQ-5D

    Time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery

    EuroQol (EQ-5D) measures health-related quality of life on a scale where 0.0 equal's death and 1.0 equals perfect health

  4. ODI

    Time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery

    Oswestry Disability Index (ODI) questionnaire scores range from 0 (no disability) to 100 (total disability)

  5. patient characteristics

    Time frame: pre-surgery and 3 months, 12 months and 2 years post-surgery

    age, gender, BMI, smoking, diabetes

  6. reoperation

    Time frame: 3 months, 12 months and 2 years post-surgery

    operation on index level after primary operation and discharge within follow-up period

  7. complication

    Time frame: during surgery or during admission

    perisurgical complication within admission.

Sponsors and collaborators

Lead sponsor

Spine Centre of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 29, 2020
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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