Lumbar Spinal StenosisSSSSNCT01994512
Swedish Spinal Stenosis Study
A study testing Decompression without fusion and Decompression with fusion in people with Lumbar Spinal Stenosis, run by Uppsala University.
Trial summary
A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis >3mm. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Decompression without fusion and Decompression with fusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 245 participants
- Where
- No sites listed yet
- Study dates
- Oct 2006to Jun 2014
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pseudoclaudication in one or both legs and backpain (VAS>30)
- MRI with 1-2 adjacent stenotic segments (area <0.75 mm2)between L2 and sacrum
- Duration of symptoms >6 months
- Informed consent
Who cannot join
- Spondylolysis
- Degenerative lumbar scoliosis (Cobb angle >20 deg)
- History of lumbar spinal surgery for spinal stenosis or instability
- Stenosis not caused by degenerative changes
- Stenosis caused by herniated disc
- Other specific spinal conditions, Mb Bechterew, malignancy, neurologic disorders
- History of vertebral compression fractures in affected segments
- Psychological disorders where the surgeon considers participation inappropriate(dementia, drug abuse)
About this study
Official title: Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.
A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis >3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Decompression without fusion, Decompression with fusion
- Keywords
- Spinal stenosis, Decompression, Fusion, Olisthesis
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression without fusionProcedure or surgery
Decompressive surgery of both central and lateral component of the stenosis.
Decompression with fusionProcedure or surgery
Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.
| Study group | Role | What they receive |
|---|---|---|
| Decompression without fusion | Experimental | Surgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion. Receives: Procedure: Decompression without fusion |
| Decompression with fusion | Experimental | Surgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion. Receives: Procedure: Decompression with fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
A difference in ODI of 12 at follow up between the two interventions is considered as significant.
Measured: 2 years
Secondary outcomes (4)
Back pain
The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.
Measured: 2 years
Leg pain
The visual analog scale (VAS 0-100) is used the evaluate pain. A difference of 20 between the interventions is considered significant.
Measured: 2 years
EuroQol (EQ-5D)
Measurement of quality of life
Measured: 2 years
Swiss Spinal Stenosis Questionnaire
A disease-specific self-report outcome instrument commonly used in trials to measure treatment outcomes in patients with lumbar spinal stenosis. The Swiss Spinal Stenosis Questionnaire quantifies severity of symptoms, physical function characteristics, and patient's satisfaction after treatment. It was designed to complement existing generic measures of lumbar spine disability and health status in the evaluation of patients with lumbar spinal stenosis.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startOct 2006
- Primary completionJun 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 245 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01994512
- Sponsor's protocol ID
- SS 01
- Acronym
- SSSS
- Status last verified
- Dec 2015
- First submitted
- 19 Nov 2013
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.
PubMed 27074066
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swedish Spinal Stenosis Study. An RCT Comparing Decompression With Fusion to Decompression Only in Lumbar Spinal Stenosis With or Without Degenerative Olisthesis.
- ClinicalTrials.gov ID
- NCT01994512
- Acronym / sponsor ID
- SSSS / SS 01
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Spinal stenosis, Decompression, Fusion, Olisthesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 245 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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.
A national randomized multicentre trial (RCT) where decompression is compared with decompression with simultaneous fusion in 245 patients with spinal stenosis on one or two adjacent lumbar levels with or without degenerative olisthesis. The material is stratified for the existence of degenerative olisthesis >3mm. Monitoring is performed with clinical results from patient surveys after 2 and five years, and with radiological follow-up (MRI, CT and plain X-ray) and an objective function test (6 min walking test) after 2 years. The null hypothesis is that there is no difference in results between the two interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompression without fusion | Experimental | Procedure: Decompression without fusionSurgery of the stenotic spinal segments with decompression of the neural elements without concommitant fusion. |
| Decompression with fusion | Experimental | Procedure: Decompression with fusionSurgery of the stenotic spinal segments with decompression of the neural elements with concommitant fusion. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pseudoclaudication in one or both legs and backpain (VAS>30)
- MRI with 1-2 adjacent stenotic segments (area <0.75 mm2)between L2 and sacrum
- Duration of symptoms >6 months
- Informed consent
Key exclusion criteria (8 listed)
- Spondylolysis
- Degenerative lumbar scoliosis (Cobb angle >20 deg)
- History of lumbar spinal surgery for spinal stenosis or instability
- Stenosis not caused by degenerative changes
- Stenosis caused by herniated disc
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 |
|---|---|---|
| Decompression without fusionDecompressive surgery of both central and lateral component of the stenosis. | Procedure or surgery | Decompression without fusion |
| Decompression with fusionDecompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments. | Procedure or surgery | Decompression with fusion |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 2 years
A difference in ODI of 12 at follow up between the two interventions is considered as significant.
4 secondary outcomes
Back pain
Time frame: 2 years
Leg pain
Time frame: 2 years
EuroQol (EQ-5D)
Time frame: 2 years
Swiss Spinal Stenosis Questionnaire
Time frame: 2 years
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 17 Dec 2015.
- Derived from this study: PubMed 27074066Forsth P, Olafsson G, Carlsson T, Frost A, Borgstrom F, Fritzell P, Ohagen P, Michaelsson K, Sanden B. A Randomized, Controlled Trial of Fusion Surgery for Lumbar Spinal Stenosis. N Engl J Med. 2016 Apr 14;374(15):1413-23. doi: 10.1056/NEJMoa1513721.
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LUMBAR STENOSIS
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression without fusion and Decompression with fusion in people with Lumbar Spinal Stenosis, run by Uppsala University.
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 4 inclusion and 8 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 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01994512, which also lists 1 linked publication.
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 17 Dec 2015.