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

Sponsors

Lead Sponsor: Spine Centre of Southern Denmark

Source 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 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

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 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.

Overall Status Not yet recruiting
Start Date May 31, 2020
Completion Date October 31, 2020
Primary Completion Date July 31, 2020
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
facet joint gap pre-surgery
Secondary Outcome
Measure Time Frame
facet angel pre-surgery
disc height pre-surgery
anterior translation pre-surgery
intradiscal vacuum pre-surgery
radiographic slip pre-surgery
Enrollment 2100
Condition
Intervention

Intervention Type: Procedure

Intervention Name: decompression

Description: 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.

Arm Group Label: decompression

Intervention Type: Procedure

Intervention Name: fusion

Description: 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.

Arm Group Label: fusion

Other Name: arthodese

Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 110 Years

Overall Official
Last Name Role Affiliation
Signe Forbech Elmose, M.D. Principal Investigator Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark
Overall Contact

Last Name: Signe Forbech Elmose, M.D.

Phone: +45 26390783

Email: [email protected]

Verification Date

May 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: decompression

Description: patients treated with decompression for lumbar spinal stenosis

Label: fusion

Description: patients treated with decompression with fusion for lumbar spinal stenosis

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov