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| ID | Type | Description | Link |
|---|---|---|---|
| 20202000-22 | Other Identifier | National Committee on Health Research Ethics |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| decompression | patients treated with decompression for lumbar spinal stenosis |
| |
| fusion | patients treated with decompression with fusion for lumbar spinal stenosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| facet joint gap | MRI proxies 1 | pre-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| facet angel | MRI proxies 2 | pre-surgery |
| disc height | MRI proxies 3 | pre-surgery |
| 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 |
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Signe Forbech Elmose, M.D. | Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for spine surgery and research, Spine Center of Southern Denmark | Middelfart | 5500 | Denmark |
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| 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. |
|
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| anterior translation | MRI proxies 4 | pre-surgery |
| intradiscal vacuum | MRI proxies 5 | pre-surgery |
| radiographic slip | anterior translation on lateral radiograph | pre-surgery |
| 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 |
| ID | Term |
|---|---|
| D003664 | Decompression |
| D050939 | Gene Fusion |
| D001174 | Arthrodesis |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011312 | Pressure |
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
| D011995 | Recombination, Genetic |
| D055614 | Genetic Phenomena |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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