Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)
NCT ID: NCT04406987
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
235 participants
OBSERVATIONAL
2021-06-30
2021-12-10
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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decompression
patients treated with decompression for lumbar spinal stenosis
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
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.
Interventions
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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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* malignancy or undergoing treatment for malignancy
* scoliosis Cobb angel \>20 degrees
18 Years
110 Years
ALL
No
Sponsors
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Spine Centre of Southern Denmark
OTHER
Responsible Party
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Principal Investigators
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Signe Forbech Elmose, M.D.
Role: PRINCIPAL_INVESTIGATOR
Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark
Locations
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Center for spine surgery and research, Spine Center of Southern Denmark
Middelfart, , Denmark
Countries
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Other Identifiers
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20202000-22
Identifier Type: OTHER
Identifier Source: secondary_id
20/7176
Identifier Type: -
Identifier Source: org_study_id