Degenerative Lumbar Spinal StenosisNCT04406987
Instability in the Lumbar Spine of Patients With Age Related Changes and Narrowing of the Spinal Canal (Spinal Stenosis)
An observational study of Degenerative Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, run by Spine Centre of Southern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
- What is being tested?
- decompression and fusion
- Type of treatment
- Surgery or procedure
- How many people
- 235 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Jun 2021to 10 Dec 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 110 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- previous surgery at the same level,
- malignancy or undergoing treatment for malignancy
- scoliosis Cobb angel >20 degrees
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Center for spine surgery and research, Spine Center of Southern Denmark
Middelfart, 5500
About this study
Official title: Degenerative Segmental Instability in Lumbar Spinal Stenosis Patients - Study on Instability, Clinical Outcomes, Reoperation Rate With a 2 Year Follow up
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
Read the 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 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.
- Being tested
- decompression, fusion
- Keywords
- instability, anterior translation, slip, segmental motion, radiologic assesment, lumbar MRI, MRI characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
decompressionProcedure or surgery
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.
fusionProcedure or surgery
Also called arthrodese
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.
| Study group | Role | What they receive |
|---|---|---|
| decompression | patients treated with decompression for lumbar spinal stenosis Receives: Procedure: decompression | |
| fusion | patients treated with decompression with fusion for lumbar spinal stenosis Receives: Procedure: fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
facet joint gap
MRI proxies 1
Measured: pre-surgery
Secondary outcomes (5)
facet angel
MRI proxies 2
Measured: pre-surgery
disc height
MRI proxies 3
Measured: pre-surgery
anterior translation
MRI proxies 4
Measured: pre-surgery
intradiscal vacuum
MRI proxies 5
Measured: pre-surgery
radiographic slip
anterior translation on lateral radiograph
Measured: pre-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2020
- Study start30 Jun 2021
- Primary completion5 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 235 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Signe Forbech Elmose, M.D., Principal investigator, Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406987
- Sponsor's protocol ID
- 20/7176
- Other IDs
- 20202000-22
- Status last verified
- Dec 2021
- First submitted
- 24 May 2020
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Degenerative Segmental Instability in Lumbar Spinal Stenosis Patients - Study on Instability, Clinical Outcomes, Reoperation Rate With a 2 Year Follow up
- ClinicalTrials.gov ID
- NCT04406987
- Acronym / sponsor ID
- 20/7176
- Keywords
- instability, anterior translation, slip, segmental motion, radiologic assesment, lumbar MRI, MRI characteristics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 235 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 29 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decompression | – | Procedure: decompressionpatients treated with decompression for lumbar spinal stenosis |
| fusion | – | Procedure: fusionpatients treated with decompression with fusion for lumbar spinal stenosis |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- previous surgery at the same level,
- malignancy or undergoing treatment for malignancy
- scoliosis Cobb angel >20 degrees
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decompressionsurgical 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. | Procedure or surgery | decompression |
| fusionAlso: arthrodesefusion 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. | Procedure or surgery | fusion |
Primary outcome
facet joint gap
Time frame: pre-surgery
MRI proxies 1
5 secondary outcomes
facet angel
Time frame: pre-surgery
disc height
Time frame: pre-surgery
anterior translation
Time frame: pre-surgery
intradiscal vacuum
Time frame: pre-surgery
radiographic slip
Time frame: pre-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe Forbech Elmose, M.D. principal investigator
Spine Center of Southern Denmark, Lillebaelt Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, run by Spine Centre of Southern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
facet joint gap (time frame: pre-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.