Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)
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|ClinicalTrials.gov Identifier: NCT04406987|
Recruitment Status : Not yet recruiting
First Posted : May 29, 2020
Last Update Posted : June 4, 2020
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 simpel 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
|Condition or disease||Intervention/treatment|
|Degenerative Lumbar Spinal Stenosis Degenerative Spondylolisthesis||Procedure: decompression Procedure: fusion|
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 Örebro 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 responsrate. 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 constent and recieves 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 expirence 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 analyzis.
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 [Patient Registry]|
|Estimated Enrollment :||2100 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Degenerative Segmental Instability in Lumbar Spinal Stenosis Patients - Study on Instability, Clinical Outcomes, Reoperation Rate With a 2 Year Follow up|
|Estimated Study Start Date :||May 31, 2020|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||October 31, 2020|
patients treated with decompression for lumbar spinal stenosis
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.
patients treated with decompression with fusion for lumbar spinal stenosis
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 descretion.
Other Name: arthodese
- facet joint gap [ Time Frame: pre-surgery ]MRI proxies 1
- facet angel [ Time Frame: pre-surgery ]MRI proxies 2
- disc height [ Time Frame: pre-surgery ]MRI proxies 3
- anterior translation [ Time Frame: pre-surgery ]MRI proxies 4
- intradiscal vacuum [ Time Frame: pre-surgery ]MRI proxies 5
- radiographic slip [ Time Frame: pre-surgery ]anterior translation on lateral radiograph
- 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
- 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
- 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
- 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)
- patient characteristics [ Time Frame: pre-surgery and 3 months, 12 months and 2 years post-surgery ]age, gender, BMI, smoking, diabetes
- reoperation [ Time Frame: 3 months, 12 months and 2 years post-surgery ]operation on index level after primary operation and discharge within follow-up periode
- complication [ Time Frame: during surgery or during admission ]perisurgical complication within admission periode.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406987
|Contact: Signe Forbech Elmose, M.D.||+45 email@example.com|
|Principal Investigator:||Signe Forbech Elmose, M.D.||Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark|