Spinal StenosisPhase 3SLIPNCT00109213
Greenwich Lumbar Stenosis SLIP Study
A Phase 3 study testing Lumbar Laminectomy with Instrumented Pedicle Screw Fusion and Lumbar Laminectomy in people with Spinal Stenosis and Spondylolisthesis, run by Greenwich Hospital at 5 sites in United States.
Trial summary
The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spinal Stenosis, Spondylolisthesis
- What is being tested?
- Lumbar Laminectomy with Instrumented Pedicle Screw Fusion and Lumbar Laminectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 5 sitesUnited States
- Study dates
- May 2002to Oct 2014
- Phase
- Phase 3
- 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
- Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)
Who cannot join
- History of previous lumbar spinal surgery in region of stenosis
- Gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies)
- Serious medical illness (ASA Class III or higher)
- Spondylolisthesis greater than 14 mm or associated with spondylolysis
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Lahey Clinic
Burlington, Massachusetts, 01805
Cleveland Clinic Spine Institute
Cleveland, Ohio, 44195
Greenwich Hospital
Greenwich, Connecticut, 06830
Rhode Island Hospital
Providence, Rhode Island, 02903
About this study
Official title: Greenwich Lumbar Stenosis SLIP Study: A Multi-center, Randomized, Prospective Clinical Trial Comparing Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis
The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.
Read the detailed description
There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.
- Conditions
- Spinal Stenosis, Spondylolisthesis
- Being tested
- Lumbar Laminectomy with Instrumented Pedicle Screw Fusion, Lumbar Laminectomy
- Keywords
- Spinal Stenosis, Lumbar Spine, Decompression, Fusion, Spondylolisthesis, Prospective, randomized clinical trial
- 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.
Lumbar Laminectomy with Instrumented Pedicle Screw FusionProcedure or surgery
Removal of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine
Lumbar LaminectomyProcedure or surgery
Removal of bone to decompress spinal nerves
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lumbar Laminectomy without Fusion Receives: Procedure: Lumbar Laminectomy |
| 2 | Active comparator | Lumbar Laminectomy with Pedicle Screw Instrumented Fusion Receives: Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw Fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
SF-36 (physical component summary score)
Measured: 2 year
Secondary outcomes (2)
Oswestry Disability Index
Measured: 2 year, 3 year, 4 year
Major Complication rate
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2005 (estimated)
- Study startMay 2002
- Primary completionSep 2009
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greenwich Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zoher Ghogawala, MD, Study director, Yale University School of Medicine (Greenwich Hospital)Edward C Benzel, MD, Study director, Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109213
- Sponsor's protocol ID
- GH-SLIP-384
- Acronym
- SLIP
- Status last verified
- Dec 2015
- First submitted
- 26 Apr 2005
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ghogawala Z, Benzel EC, Amin-Hanjani S, Barker FG 2nd, Harrington JF, Magge SN, Strugar J, Coumans JV, Borges LF. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine. 2004 Oct;1(3):267-72. doi: 10.3171/spi.2004.1.3.0267.
PubMed 15478364Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2807-12. doi: 10.1097/00007632-199712150-00003.
PubMed 9431616Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
PubMed 2071615Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.
PubMed 27074067Ghogawala Z, Schwartz JS, Benzel EC, Magge SN, Coumans JV, Harrington JF, Gelbs JC, Whitmore RG, Butler WE, Barker FG 2nd. Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel. Ann Surg. 2016 Jul;264(1):81-6. doi: 10.1097/SLA.0000000000001483.
PubMed 26501698Blumenthal C, Curran J, Benzel EC, Potter R, Magge SN, Harrington JF Jr, Coumans JV, Ghogawala Z. Radiographic predictors of delayed instability following decompression without fusion for degenerative grade I lumbar spondylolisthesis. J Neurosurg Spine. 2013 Apr;18(4):340-6. doi: 10.3171/2013.1.SPINE12537. Epub 2013 Feb 1.
PubMed 23373567
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greenwich Lumbar Stenosis SLIP Study: A Multi-center, Randomized, Prospective Clinical Trial Comparing Spinal Laminectomy to Laminectomy With Instrumented Pedicle Screw Fusion for Lumbar Stenosis With Grade I Spondylolisthesis
- ClinicalTrials.gov ID
- NCT00109213
- Acronym / sponsor ID
- SLIP / GH-SLIP-384
- Conditions
- Spinal Stenosis, Spondylolisthesis
- Keywords
- Spinal Stenosis, Lumbar Spine, Decompression, Fusion, Spondylolisthesis, Prospective, randomized clinical trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Greenwich HospitalUniversity, hospital or other
- Study start
- May 2002
- Primary completion
- Sep 2009 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 26 Apr 2005 (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 the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.
Detailed description
There is considerable debate among spinal surgeons regarding the optimal surgical procedure for lumbar spinal stenosis with a grade I spondylolisthesis. The major question is whether or not instrumented pedicle screw fusion should be undertaken when a decompressive laminectomy is performed to relieve neural compression. This multi-center, randomized, prospective clinical study aims to address this question by testing the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long-term patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Lumbar LaminectomyLumbar Laminectomy without Fusion |
| 2 | Active comparator | Procedure: Lumbar Laminectomy with Instrumented Pedicle Screw FusionLumbar Laminectomy with Pedicle Screw Instrumented Fusion |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic lumbar spinal stenosis and single level grade I spondylolisthesis (3-14 mm)
Key exclusion criteria (4 listed)
- History of previous lumbar spinal surgery in region of stenosis
- Gross spinal instability (defined as greater than 3 mm motion on flexion/extension studies)
- Serious medical illness (ASA Class III or higher)
- Spondylolisthesis greater than 14 mm or associated with spondylolysis
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 |
|---|---|---|
| Lumbar Laminectomy with Instrumented Pedicle Screw FusionRemoval of bone to decompress spinal nerves with placement of spinal screws and extra bone to strengthen the spine | Procedure or surgery | 2 |
| Lumbar LaminectomyRemoval of bone to decompress spinal nerves | Procedure or surgery | 1 |
Primary outcome
SF-36 (physical component summary score)
Time frame: 2 year
2 secondary outcomes
Oswestry Disability Index
Time frame: 2 year, 3 year, 4 year
Major Complication rate
Time frame: 30 days
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 3 Dec 2015.
- Background: PubMed 15478364Ghogawala Z, Benzel EC, Amin-Hanjani S, Barker FG 2nd, Harrington JF, Magge SN, Strugar J, Coumans JV, Borges LF. Prospective outcomes evaluation after decompression with or without instrumented fusion for lumbar stenosis and degenerative Grade I spondylolisthesis. J Neurosurg Spine. 2004 Oct;1(3):267-72. doi: 10.3171/spi.2004.1.3.0267.
- Background: PubMed 9431616Fischgrund JS, Mackay M, Herkowitz HN, Brower R, Montgomery DM, Kurz LT. 1997 Volvo Award winner in clinical studies. Degenerative lumbar spondylolisthesis with spinal stenosis: a prospective, randomized study comparing decompressive laminectomy and arthrodesis with and without spinal instrumentation. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2807-12. doi: 10.1097/00007632-199712150-00003.
- Background: PubMed 2071615Herkowitz HN, Kurz LT. Degenerative lumbar spondylolisthesis with spinal stenosis. A prospective study comparing decompression with decompression and intertransverse process arthrodesis. J Bone Joint Surg Am. 1991 Jul;73(6):802-8.
- Derived from this study: PubMed 27074067Ghogawala Z, Dziura J, Butler WE, Dai F, Terrin N, Magge SN, Coumans JV, Harrington JF, Amin-Hanjani S, Schwartz JS, Sonntag VK, Barker FG 2nd, Benzel EC. Laminectomy plus Fusion versus Laminectomy Alone for Lumbar Spondylolisthesis. N Engl J Med. 2016 Apr 14;374(15):1424-34. doi: 10.1056/NEJMoa1508788.
- Derived from this study: PubMed 26501698Ghogawala Z, Schwartz JS, Benzel EC, Magge SN, Coumans JV, Harrington JF, Gelbs JC, Whitmore RG, Butler WE, Barker FG 2nd. Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel. Ann Surg. 2016 Jul;264(1):81-6. doi: 10.1097/SLA.0000000000001483.
- Derived from this study: PubMed 23373567Blumenthal C, Curran J, Benzel EC, Potter R, Magge SN, Harrington JF Jr, Coumans JV, Ghogawala Z. Radiographic predictors of delayed instability following decompression without fusion for degenerative grade I lumbar spondylolisthesis. J Neurosurg Spine. 2013 Apr;18(4):340-6. doi: 10.3171/2013.1.SPINE12537. Epub 2013 Feb 1.
Related trials for Spinal Stenosis
Recruiting
Activity Post Spinal Surgery Engagement Trial
Spinal Surgery for Lumbar Spinal Stenosis (LSS)
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Active, not recruiting
SLIP II Registry: Spinal Laminectomy Versus Instrumented Pedicle Screw Fusion
Lumbar Spondylolisthesis, Grade 1 Spondylolisthesis
RecruitingObservational study
MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study
Lumbar Spinal Stenosis
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy
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.
Zoher Ghogawala, MD study director
Yale University School of Medicine (Greenwich Hospital)
Edward C Benzel, MD study director
Cleveland Clinic Spine Institute (Cleveland Clinic Foundation)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lumbar Laminectomy with Instrumented Pedicle Screw Fusion and Lumbar Laminectomy in people with Spinal Stenosis and Spondylolisthesis, run by Greenwich Hospital at 5 sites in United States.
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 4 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 3 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
SF-36 (physical component summary score) (time frame: 2 year). 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 NCT00109213, which also lists 6 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 3 Dec 2015.