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

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

Study Overview

• Status: Completed
• Conditions: Degenerative Spondylolisthesis; Degenerative Lumbar Spinal Stenosis
• Intervention / Treatment: Procedure: decompression; Procedure: fusion

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.

• Study Type: Observational
• Enrollment (Actual): 235

Contacts and Locations

Study Locations

• Denmark
  • Middelfart, Denmark, 5500
    • Center for spine surgery and research, Spine Center of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Consecutive patients with symptomatic, MRI-verifeis lumbar spinal stenosis referred to Spine Center of Southern Denmark between 2010-2017. And same study population referred to Spine Centers at hospitals in Malmö, Lund, Trelleborg and Karlskroga Sweden between 2010-2017.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
decompression; patients treated with decompression for lumbar spinal stenosis	Procedure: decompression; 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; patients treated with decompression with fusion for lumbar spinal stenosis	Procedure: fusion; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
facet joint gap	MRI proxies 1	pre-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
facet angel	MRI proxies 2	pre-surgery
disc height	MRI proxies 3	pre-surgery
anterior translation	MRI proxies 4	pre-surgery
intradiscal vacuum	MRI proxies 5	pre-surgery
radiographic slip	anterior translation on lateral radiograph	pre-surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS leg	Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale	pre-surgery and 3 months, 12 months and 2 years post-surgery
VAS back	Visual Analog Scale (VAS) a 0 (no pain) to 100 (severe pain) point scale	pre-surgery and 3 months, 12 months and 2 years post-surgery
EQ-5D	EuroQol (EQ-5D) measures health-related quality of life on a scale where 0.0 equal's death and 1.0 equals perfect health	pre-surgery and 3 months, 12 months and 2 years post-surgery
ODI	Oswestry Disability Index (ODI) questionnaire scores range from 0 (no disability) to 100 (total disability)	pre-surgery and 3 months, 12 months and 2 years post-surgery
patient characteristics	age, gender, BMI, smoking, diabetes	pre-surgery and 3 months, 12 months and 2 years post-surgery
reoperation	operation on index level after primary operation and discharge within follow-up period	3 months, 12 months and 2 years post-surgery
complication	perisurgical complication within admission.	during surgery or during admission

Collaborators and Investigators

• Sponsor: Spine Centre of Southern Denmark
• Investigators: Principal Investigator: Signe Forbech Elmose, M.D., Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 30, 2021
• Primary Completion (ACTUAL): December 5, 2021
• Study Completion (ACTUAL): December 10, 2021

Study Registration Dates

• First Submitted: May 24, 2020
• First Submitted That Met QC Criteria: May 24, 2020
• First Posted (ACTUAL): May 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 14, 2021
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: instability; anterior translation; slip; segmental motion; radiologic assesment; lumbar MRI; MRI characteristics
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Constriction, Pathologic; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: 20/7176; 20202000-22 (OTHER: National Committee on Health Research Ethics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No