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

Degenerative Spondylolisthesis Clinical Trial

Official title:

Degenerative Segmental Instability in Lumbar Spinal Stenosis Patients - Study on Instability, Clinical Outcomes, Reoperation Rate With a 2 Year Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04406987
• Other study ID #: 20/7176
• Secondary ID: 20202000-22
• Status: Completed
• Start date: June 30, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: December 2021
• Source: Spine Centre of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: December 10, 2021
• Est. primary completion date: December 5, 2021
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Degenerative Lumbar Spinal Stenosis
• Degenerative Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Denmark	Center for spine surgery and research, Spine Center of Southern Denmark	Middelfart

Sponsors (1)

Lead Sponsor	Collaborator
Spine Centre of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	VAS back	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
Other	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
Other	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
Other	patient characteristics	age, gender, BMI, smoking, diabetes	pre-surgery and 3 months, 12 months and 2 years post-surgery
Other	reoperation	operation on index level after primary operation and discharge within follow-up period	3 months, 12 months and 2 years post-surgery
Other	complication	perisurgical complication within admission.	during surgery or during admission
Primary	facet joint gap	MRI proxies 1	pre-surgery
Secondary	facet angel	MRI proxies 2	pre-surgery
Secondary	disc height	MRI proxies 3	pre-surgery
Secondary	anterior translation	MRI proxies 4	pre-surgery
Secondary	intradiscal vacuum	MRI proxies 5	pre-surgery
Secondary	radiographic slip	anterior translation on lateral radiograph	pre-surgery