Spinal StenosisNCT04166981
Instr. vs. Non-instr. Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis
A study testing Instrumented posterolateral spine fusion. and Non-instrumented posterolateral spine fusion. in people with Spinal Stenosis and Spondylolisthesis Degenerative, run by Spine Centre of Southern Denmark at 1 site in Denmark.
Trial summary
The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Spinal Stenosis, Spondylolisthesis Degenerative, Spinal Fusion
- What is being tested?
- Instrumented posterolateral spine fusion. and Non-instrumented posterolateral spine fusion.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2017to 1 Dec 2021
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Lumbar Spinal stenosis, with neurogenic claudication, radicular pain and,
- Confirmatory MRI scan showing lumbar spinal stenosis on 1-2 levels from L1-S1
- Standing X-ray showing grade 1 spondylolisthesis on one level
- Age 60 and above
- Symptom duration of 3+ months
Who cannot join
- Stenosis caused by herniated disc
- Prior vertebral compression fracture in the affected segments
- Active malignancy
- Current fracture, infection og deformity of the spine
- Stenosis on 3 or more levels
- MMSE test score below 24
Show all 9Show fewer
- Neuromuscular disease
- Obligatory peroral steroid treatment
- ASA grade 3 or more.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Instrumented vs. Non-instrumented Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis
The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.
Read the detailed description
Lumbar spinal stenosis (LSS) is a common disease with a large impact on the quality of life of the patient. LSS is defined as narrowing of the spinal canal, nerve root canal or intervertebral foramina. Spinal stenosis is caused by degenerative changes in the lumbar spine, including thickening of the ligamentum flavum, osteophyte formation and disc protrusion. Pain is worse with standing upright and with exercise, and relieved with spine flexion or sitting down.
In the Wakayama Spine Study, investigators found radiographic severe spinal stenosis, defined as narrowing of more than two-thirds of the spinal canal area, in 30,4% of all patients, but only 17,5% were symptomatic.
Many of the patients suffering from LSS are pensioners, with an average age of 65 years. With current changes in demographics and the aging global population it is estimated that prevalence of LSS will increase to nearly 60% by 2025.
In a Danish epidemiological study, degenerative spondylolisthesis was found in 2,7% of men and 8,4% of women above 50 years. Every year, more than 3500 patients aged 60 and above are referred to Center of Spine Surgery Middelfart for LSS. According to the national Danish surgical spine database, DaneSpine, 7936 patients with LSS had surgery during a period from 2009-2013.
Patients suffering from LSS and instability are treated with decompression and posterolateral spinal fusion with or without instrumentation. According to DaneSpine, this group of patients showed improvements on both physical and psychological parameters. In countries outside of Scandinavia, these patients are usually treated with decompression and posterolateral spinal fusion with supplementary pedicle screw fixation. Instrumentation with pedicle screws and rods provides an internal splint, preventing motion during fusion healing. The fusion rate in non-instrumented arthrodesis is reported to be as low as 30-45% In contrast the fusion rate with instrumented arthrodesis have been reported to be above 80%. Although some studies have shown similar outcomes after decompression with or without instrumentation, long-term follow up has shown that a solid fusion improves clinical outcome.
In recent retrospective studies, the spinal sagittal balance, specifically the sagittal vertical axis (SVA) has been shown to affect the outcome of patients undergoing laminectomy. Decompression surgery has been shown to improve sagittal balance in patients with a preoperative imbalance, compared to patients treated with rehabilitation. The preoperative sagittal imbalance has not been shown to significantly affect health-related quality of life(HRQoL)outcomes although a residual imbalance after decompression is related to a poorer outcome. No prospective studies to our knowledge have compared the sagittal balance and outcomes in patients with spinal stenosis and spondylolisthesis, treated with decompression and spinal fusion with or without supplemental pedicle screw fixation.
- Being tested
- Instrumented posterolateral spine fusion., Non-instrumented posterolateral spine fusion.
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented posterolateral spine fusion.Procedure or surgery
Also called Decompression on affected level
Posterolateral fusion with autologous and allogenic bone graft with supplementary pedicle screw fixation.
Non-instrumented posterolateral spine fusion.Procedure or surgery
Also called Decompression on affected level
Posterolateral fusion with autologous and allogenic bone graft.
| Study group | Role | What they receive |
|---|---|---|
| Non-instrumented arm | Active comparator | Decompression with concomitant non-instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft. Receives: Procedure: Non-instrumented posterolateral spine fusion. |
| Instrumented arm | Experimental | Decompression with concomitant instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft and supplementary pedicle screw fixation. Receives: Procedure: Instrumented posterolateral spine fusion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index(ODI)
A disease specific measure of physical disability in an index score ranging from 0-100, 0 being the best possible outcome and 100 being the worst. Comparing the effectiveness of the two arms.
Measured: 2 years after surgery
Secondary outcomes (4)
Achieved solid posterolateral fusion
Fine cut CT-scans, evaluated by 3 observers to determine if solid posterolateral fusion is achieved.
Measured: CT-scans 1 year after surgery
Change in sagittal balance, effect on outcome.
Lateral scoliosis X-rays obtained pre operatively and after 1 and 2 years.
Measured: Pre operative, 1 and 2 years after surgery
European Quality of life - 5 Dimensions (EQ-5D)
Changes in quality of life in the study groups, Obtained preoperatively, after 3 months, 1 year and 2 years. Scores range between -0.6 to 1.0 where 1 is perfect health.
Measured: preoperative, 3, 12 and 24 months after surgery
Difference in cost-effectiveness between instrumented versus non-instrumented fusion.
Additional cost of instrumentation, incidence of revision surgery and treatment effectiveness, measured by health state utilities. Measured in Quality adjusted Life years(QaLY) and cost of surgery measured in American dollars.
Measured: 2 years after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Jan 2017
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spine Centre of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andreas Kiilerich Andresen, Spine Centre of Southern Denmark
- Investigators
- Andreas K Andresen, MD, Principal investigator, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166981
- Sponsor's protocol ID
- S-20160107
- Status last verified
- Mar 2022
- First submitted
- 4 Nov 2019
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All individual patient data that underlies the results reported in this article, after deidentification. (texts, tables, figures)
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instrumented vs. Non-instrumented Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative Listhesis
- ClinicalTrials.gov ID
- NCT04166981
- Acronym / sponsor ID
- S-20160107
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Spine Centre of Southern DenmarkUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 18 Nov 2019 (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.
The aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.
Detailed description
Lumbar spinal stenosis (LSS) is a common disease with a large impact on the quality of life of the patient. LSS is defined as narrowing of the spinal canal, nerve root canal or intervertebral foramina. Spinal stenosis is caused by degenerative changes in the lumbar spine, including thickening of the ligamentum flavum, osteophyte formation and disc protrusion. Pain is worse with standing upright and with exercise, and relieved with spine flexion or sitting down.
In the Wakayama Spine Study, investigators found radiographic severe spinal stenosis, defined as narrowing of more than two-thirds of the spinal canal area, in 30,4% of all patients, but only 17,5% were symptomatic.
Many of the patients suffering from LSS are pensioners, with an average age of 65 years. With current changes in demographics and the aging global population it is estimated that prevalence of LSS will increase to nearly 60% by 2025.
In a Danish epidemiological study, degenerative spondylolisthesis was found in 2,7% of men and 8,4% of women above 50 years. Every year, more than 3500 patients aged 60 and above are referred to Center of Spine Surgery Middelfart for LSS. According to the national Danish surgical spine database, DaneSpine, 7936 patients with LSS had surgery during a period from 2009-2013.
Patients suffering from LSS and instability are treated with decompression and posterolateral spinal fusion with or without instrumentation. According to DaneSpine, this group of patients showed improvements on both physical and psychological parameters. In countries outside of Scandinavia, these patients are usually treated with decompression and posterolateral spinal fusion with supplementary pedicle screw fixation. Instrumentation with pedicle screws and rods provides an internal splint, preventing motion during fusion healing. The fusion rate in non-instrumented arthrodesis is reported to be as low as 30-45% In contrast the fusion rate with instrumented arthrodesis have been reported to be above 80%. Although some studies have shown similar outcomes after decompression with or without instrumentation, long-term follow up has shown that a solid fusion improves clinical outcome.
In recent retrospective studies, the spinal sagittal balance, specifically the sagittal vertical axis (SVA) has been shown to affect the outcome of patients undergoing laminectomy. Decompression surgery has been shown to improve sagittal balance in patients with a preoperative imbalance, compared to patients treated with rehabilitation. The preoperative sagittal imbalance has not been shown to significantly affect health-related quality of life(HRQoL)outcomes although a residual imbalance after decompression is related to a poorer outcome. No prospective studies to our knowledge have compared the sagittal balance and outcomes in patients with spinal stenosis and spondylolisthesis, treated with decompression and spinal fusion with or without supplemental pedicle screw fixation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-instrumented arm | Active comparator | Procedure: Non-instrumented posterolateral spine fusion.Decompression with concomitant non-instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft. |
| Instrumented arm | Experimental | Procedure: Instrumented posterolateral spine fusion.Decompression with concomitant instrumented posterolateral fusion with autologous(obtained from the decompression) and allogenic bone graft and supplementary pedicle screw fixation. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with Lumbar Spinal stenosis, with neurogenic claudication, radicular pain and,
- Confirmatory MRI scan showing lumbar spinal stenosis on 1-2 levels from L1-S1
- Standing X-ray showing grade 1 spondylolisthesis on one level
- Age 60 and above
- Symptom duration of 3+ months
Key exclusion criteria (9 listed)
- Stenosis caused by herniated disc
- Prior vertebral compression fracture in the affected segments
- Active malignancy
- Current fracture, infection og deformity of the spine
- Stenosis on 3 or more levels
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 |
|---|---|---|
| Instrumented posterolateral spine fusion.Also: Decompression on affected levelPosterolateral fusion with autologous and allogenic bone graft with supplementary pedicle screw fixation. | Procedure or surgery | Instrumented arm |
| Non-instrumented posterolateral spine fusion.Also: Decompression on affected levelPosterolateral fusion with autologous and allogenic bone graft. | Procedure or surgery | Non-instrumented arm |
Primary outcome
Oswestry Disability Index(ODI)
Time frame: 2 years after surgery
A disease specific measure of physical disability in an index score ranging from 0-100, 0 being the best possible outcome and 100 being the worst. Comparing the effectiveness of the two arms.
4 secondary outcomes
Achieved solid posterolateral fusion
Time frame: CT-scans 1 year after surgery
Change in sagittal balance, effect on outcome.
Time frame: Pre operative, 1 and 2 years after surgery
European Quality of life - 5 Dimensions (EQ-5D)
Time frame: preoperative, 3, 12 and 24 months after surgery
Difference in cost-effectiveness between instrumented versus non-instrumented fusion.
Time frame: 2 years after 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 31 Mar 2022.
- Individual participant dataSharing planned: Yes. All individual patient data that underlies the results reported in this article, after deidentification. (texts, tables, figures)
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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.
Andreas K Andresen, MD principal investigator
University of Southern Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumented posterolateral spine fusion. and Non-instrumented posterolateral spine fusion. in people with Spinal Stenosis and Spondylolisthesis Degenerative, 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 5 inclusion and 9 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 31 Mar 2022. 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?
Oswestry Disability Index(ODI) (time frame: 2 years after 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 31 Mar 2022.