Lumbar Spinal StenosisLSSSNCT00546949
Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-invasive Decompression to X-stop
A study testing Minimal invasive decompression and Interspinous Process Decompression (IPD) in people with Lumbar Spinal Stenosis and Radiculopathy, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Radiculopathy
- What is being tested?
- Minimal invasive decompression and Interspinous Process Decompression (IPD)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2007to Dec 2013
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neurogenic intermittent claudication due to lumbar spinal stenosis
- diagnosed on MRI in maximum two levels
- walking distance on 250 metres
- symptom relief on flexion of the lumbar spine
- duration of the symptoms more than 6 months
- non-operative treatment is tried or considered as not indicated
Who cannot join
- vascular claudicatio intermittens
- spinal stenosis on more than 2 levels
- cauda equina syndrome
- severe paresis
- clinical monoradiculopathy
- grave scoliosis
Show all 13Show fewer
- previous lumbar surgery
- degenerative spondylolisthesis more than 25%
- spondylolysis with listhesis
- osteoporotic fracture in lumbal column
- clinical and radiological (both) arthritis in the hip joint
- ASA >3
- verified polyneuropathy on neurophysiological test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)
The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)
- Conditions
- Lumbar Spinal Stenosis, Radiculopathy
- Being tested
- Minimal invasive decompression, Interspinous Process Decompression (IPD)
- Keywords
- Decompression, Surgical, x-stop, lumbar decompression, spinal stenosis, radiculopathy
- Medical subject headings
- Spinal Stenosis, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal invasive decompressionProcedure or surgery
Also called mini-invasive decompression
foraminotomy, laminotomy, microscopic decompression
Interspinous Process Decompression (IPD)Procedure or surgery
Also called X-stop
Interspinous device
| Study group | Role | What they receive |
|---|---|---|
| decompression | Active comparator | Minimal invasive decompression Receives: Procedure: Minimal invasive decompression |
| x-stop | Experimental | X-stop, an interspinous decompression device Receives: Procedure: Interspinous Process Decompression (IPD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Claudication
Zürich Claudication Questionnaire
Measured: 2 years
Secondary outcomes (1)
self-evaluated health condition
SF36, Oswestry Disability Index (ODI), EQ5-D and VAS scale
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 posted19 Oct 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2011
- Study completionDec 2013
Why it stopped: analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Greger Lønne, MD, Principal investigator, Norwegian University of Sciense and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00546949
- Sponsor's protocol ID
- NSSL-16279
- Acronym
- LSSS
- Status last verified
- Feb 2016
- First submitted
- 18 Oct 2007
- Last updated
- 25 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lonne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard OP. Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015 Jan 15;40(2):77-85. doi: 10.1097/BRS.0000000000000691.
PubMed 25575084Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, Nygaard OP. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514-20. doi: 10.1097/BRS.0000000000000798.
PubMed 25608246
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Lumbar Spinal Stenosis; Comparison of Two Different Surgical Methods; Mini-Invasive Decompression to X-Stop (LSSS)
- ClinicalTrials.gov ID
- NCT00546949
- Acronym / sponsor ID
- LSSS / NSSL-16279
- Conditions
- Lumbar Spinal Stenosis, Radiculopathy
- Keywords
- Decompression, Surgical, x-stop, lumbar decompression, spinal stenosis, radiculopathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Oct 2007 (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.
The purpose of this study is to compare two surgery methods on lumbar spinal stenosis: minimal invasive decompression and X-stop. It is a prospective randomized multicenter study including patients with lumbar spinal stenosis on one or two levels, and neurogenic intermittent claudication. Effect assessment will include measures of pain and self-evaluated health condition, a full economical evaluation, and areal measurements (MR imaging and roentgen analyses)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| decompression | Active comparator | Procedure: Minimal invasive decompressionMinimal invasive decompression |
| x-stop | Experimental | Procedure: Interspinous Process Decompression (IPD)X-stop, an interspinous decompression device |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- neurogenic intermittent claudication due to lumbar spinal stenosis
- diagnosed on MRI in maximum two levels
- walking distance on 250 metres
- symptom relief on flexion of the lumbar spine
- duration of the symptoms more than 6 months
Key exclusion criteria (13 listed)
- vascular claudicatio intermittens
- spinal stenosis on more than 2 levels
- cauda equina syndrome
- severe paresis
- clinical monoradiculopathy
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 |
|---|---|---|
| Minimal invasive decompressionAlso: mini-invasive decompressionforaminotomy, laminotomy, microscopic decompression | Procedure or surgery | decompression |
| Interspinous Process Decompression (IPD)Also: X-stopInterspinous device | Procedure or surgery | x-stop |
Primary outcome
Claudication
Time frame: 2 years
Zürich Claudication Questionnaire
1 secondary outcome
self-evaluated health condition
Time frame: 2 years
Results and safety
The study was stopped early (reason given: analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2016.
- Results publication: PubMed 25575084Lonne G, Johnsen LG, Rossvoll I, Andresen H, Storheim K, Zwart JA, Nygaard OP. Minimally invasive decompression versus x-stop in lumbar spinal stenosis: a randomized controlled multicenter study. Spine (Phila Pa 1976). 2015 Jan 15;40(2):77-85. doi: 10.1097/BRS.0000000000000691.
- Results publication: PubMed 25608246Lonne G, Johnsen LG, Aas E, Lydersen S, Andresen H, Ronning R, Nygaard OP. Comparing cost-effectiveness of X-Stop with minimally invasive decompression in lumbar spinal stenosis: a randomized controlled trial. Spine (Phila Pa 1976). 2015 Apr 15;40(8):514-20. doi: 10.1097/BRS.0000000000000798.
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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.
Greger Lønne, MD principal investigator
Norwegian University of Sciense and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal invasive decompression and Interspinous Process Decompression (IPD) in people with Lumbar Spinal Stenosis and Radiculopathy, run by Norwegian University of Science and Technology at 1 site in Norway.
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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 25 Feb 2016. 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 Norway. 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 was stopped early (reason given: analysis at 50% inclusion showed 4 times larger reoperation rate in X-stop group). Results are not available in the source record.
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?
Claudication (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 NCT00546949, which also lists 2 linked publications.
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 25 Feb 2016.