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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
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Degenerative Lumbar Spinal Stenosis Degenerative Spondylolisthesis Procedure: decompression Procedure: fusion

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Spinal Stenosis

Group/Cohort Intervention/treatment
decompression
patients treated with decompression for lumbar spinal stenosis
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
patients treated with decompression with fusion for lumbar spinal stenosis
Procedure: 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 descretion.
Other Name: arthodese




Primary Outcome Measures :
  1. facet joint gap [ Time Frame: pre-surgery ]
    MRI proxies 1


Secondary Outcome Measures :
  1. facet angel [ Time Frame: pre-surgery ]
    MRI proxies 2

  2. disc height [ Time Frame: pre-surgery ]
    MRI proxies 3

  3. anterior translation [ Time Frame: pre-surgery ]
    MRI proxies 4

  4. intradiscal vacuum [ Time Frame: pre-surgery ]
    MRI proxies 5

  5. radiographic slip [ Time Frame: pre-surgery ]
    anterior translation on lateral radiograph


Other Outcome Measures:
  1. 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

  2. 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

  3. 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

  4. 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)

  5. patient characteristics [ Time Frame: pre-surgery and 3 months, 12 months and 2 years post-surgery ]
    age, gender, BMI, smoking, diabetes

  6. 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

  7. complication [ Time Frame: during surgery or during admission ]
    perisurgical complication within admission periode.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
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.
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

Information from the National Library of Medicine

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


Contacts
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Contact: Signe Forbech Elmose, M.D. +45 26390783 signe.forbech.elmose@rsyd.dk

Sponsors and Collaborators
Spine Centre of Southern Denmark
Investigators
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Principal Investigator: Signe Forbech Elmose, M.D. Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark
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Responsible Party: Spine Centre of Southern Denmark
ClinicalTrials.gov Identifier: NCT04406987    
Other Study ID Numbers: 20/7176
20202000-22 ( Other Identifier: National Committee on Health Research Ethics )
First Posted: May 29, 2020    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spine Centre of Southern Denmark:
instability
anterior translation
slip
segmental motion
radiologic assesment
lumbar MRI
MRI characteristics
Additional relevant MeSH terms:
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Spinal Stenosis
Spondylolisthesis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Spondylolysis
Spondylosis