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

Completed

• Conditions: Degenerative Lumbar Spinal Stenosis; Degenerative Spondylolisthesis
• Interventions: Procedure: fusion; Procedure: decompression

• Registration Number: NCT04406987
• Lead Sponsor: Spine Centre of Southern Denmark

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.

Study Timeline

• Study First Submitted: 2020-05-24
• Study First Submitted QC: 2020-05-24
• Study First Posted: 2020-05-29
• Study Start: 2021-06-30
• Status Verified: 2021-12
• Primary Completion: 2021-12-05
• Study Completion: 2021-12-10
• Last Update Submitted: 2021-12-11
• Last Update Posted: 2021-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 235

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
fusion	fusion	patients treated with decompression with fusion for lumbar spinal stenosis
decompression	decompression	patients treated with decompression for lumbar spinal stenosis

Primary Outcome Measures

Name	Time	Method
facet joint gap	pre-surgery	MRI proxies 1

Secondary Outcome Measures

Name	Time	Method
intradiscal vacuum	pre-surgery	MRI proxies 5
disc height	pre-surgery	MRI proxies 3
facet angel	pre-surgery	MRI proxies 2
anterior translation	pre-surgery	MRI proxies 4
radiographic slip	pre-surgery	anterior translation on lateral radiograph

Trial Locations

Locations (1)

Center for spine surgery and research, Spine Center of Southern Denmark; 🇩🇰 Middelfart, Denmark