Lumbar Spinal StenosisNCT03012776
A Pivotal Study of the Premia Spine TOPS™ System
A study testing Total Posterior Spine System (TOPS) and Transforaminal Lumbar Interbody Fusion (TLIF) in people with Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, run by Premia Spine at 36 sites in United States.
Trial summary
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal… Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
- What is being tested?
- Total Posterior Spine System (TOPS) and Transforaminal Lumbar Interbody Fusion (TLIF)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 36 sitesUnited States
- Study dates
- 17 Jul 2017to 14 Jun 2023
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 35 and 80 years of age;
- Must demonstrate at a single level to be treated (L2/3, L3/4 or L4/5) all three of the following;
- Degenerative spondylolisthesis or retrolisthesis up to Grade I, as determined by the investigator based on flexion/extension X-rays,
- At least moderate lumbar spinal stenosis, defined as at least a 25% reduction in either the central canal, the lateral recess space, and/or the foramen when compared to an adjacent level, as determined by the investigator based on MRI,
- Thickening of the ligamentum flavum and/or scarring of the facet joint capsule as identified by the investigator based on MRI.
- Have had at least six (6) months of failed conservative treatment prior to surgery (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended dosage; administration of epidural/facet injections and/or nerve block);
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- Have an Oswestry Disability Index (ODI) score of at least 40/100 at baseline;
- Have leg pain with a VAS score of at least 40/100 for at least one leg at baseline ;
- Lower back pain with a VAS score of at least 10 points less than Worst Leg VAS score;
- Neurogenic claudication (as defined by worsening leg pain when walking or standing, which is reduced when sitting or bending forward);
Who cannot join
- Presence of free fragment disc herniation at the index level or either adjacent level;
- Less than 4mm of disc height at the index level;
- Spondylolisthesis greater than Grade I;
- Back or non-radicular leg pain of unknown etiology;
- Stenosis caused by an extruded spinal disc fragment (e.g., herniation) or where the etiology is considered to be congenital, iatrogenic, post-traumatic, or metabolic;
- Known allergy or sensitivity to PEEK, titanium, cobalt chrome, and/or polyurethane;
Show all 31Show fewer
- Prior surgery at any lumbar vertebral level with instrumentation;
- Prior surgery at the index or adjacent lumbar vertebral level;
- Clinically compromised vertebral bodies at the affected level;
- Scoliosis greater than ten (10) degrees by major Cobb angle;
- BMI > 40;
- Osteoporosis;
- Paget's disease, gout, osteomalacia, osteogenesis imperfecta, thyroid and/or parathyroid gland disorder and/or other metabolic bone disease;
- Active infection - systemic or local;
- Active hepatitis;
- AIDS, HIV, Rheumatoid arthritis or other autoimmune disease;
- Tuberculosis - active or in the past 3 years;
- Active malignancy;
- Any medical condition requiring treatment with any drug known to potentially interfere with bone/soft tissue healing or receiving radiation therapy that is expected to continue for the duration of the study;
- Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
- Vascular claudication due to severe arterial insufficiency of the legs;
- Sustained pathologic lumbar fractures of the vertebra or multiple lumbar fractures of the vertebra or hip;
- Significant peripheral neuropathy causing decreased sensation in a stocking-like or non-radicular and non-dermatomal distribution in the lower extremities;
- Insulin-dependent diabetes mellitus;
- Immunologically suppressed, receiving steroids > 1 month out of the past year;
- Current chemical/alcohol dependency;
- Current smoker or user of tobacco products;
- Pregnant or interested in becoming pregnant;
- Currently involved in active spinal litigation;
- Currently having a workman's compensation claim;
- Currently incarcerated;
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
United States36 sites
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
University of Colorado
Aurora, Colorado, 80045
Orthopaedic Associates
Bellaire, Texas, 77401
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Boulder Neurosurgical & Spine Associates
Boulder, Colorado, 80303
Lahey Clinic
Burlington, Massachusetts, 01805
Goodman Campbell Brain & Spine
Carmel, Indiana, 46032
Carolina Neurosurgery & Spine Associates, P.A.
Charlotte, North Carolina, 28204
Rush University Medical Center
Chicago, Illinois, 60612
Univ. of Cincinnati Medical Center
Cincinnati, Ohio, 45267
Florida Spine Institute
Clearwater, Florida, 33765
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Adventist Health Glendale
Glendale, California, 91206
Orthopedic Institute of Pennsylvania
Harrisburg, Pennsylvania, 17011
Marshall University
Huntington, West Virginia, 25755
St. Vincent's Spine & Brain Institute
Jacksonville, Florida, 32216
Bronson Neuroscience Center
Kalamazoo, Michigan, 49007
Cedars Sinai
Los Angeles, California, 90048
Southern Oregon Orthopedics
Medford, Oregon, 97504
Wisconsin Bone and Joint S.C.
Milwaukee, Wisconsin, 53212
Physicians Regional Medical Center
Naples, Florida, 34119
Lenox Hill Hospital
New York, New York, 10075
University of California - Irvine Medical Center
Orange, California, 92868
Eisenhower Desert Orthopedic Center
Palm Desert, California, 92270
UPENN Health Systems Department of Neurosurgery
Philadelphia, Pennsylvania, 19106
Allegheny Health Network
Pittsburgh, Pennsylvania, 15212
Texas Back Institute
Plano, Texas, 75093
Neurosurgical Associates, P.C.
Richmond, Virginia, 23229
Mayo Clinic
Rochester, Minnesota, 55905
St. Mary's Medical Center, Spine Center
San Francisco, California, 94117
Kennedy White Orthopedic Center
Sarasota, Florida, 34232
Memorial Health University Medical Center
Savannah, Georgia, 31405
Baylor Scott & White
Temple, Texas, 76508
Carle Foundation Hospital
Urbana, Illinois, 61801
Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Sibley Hospital/Johns Hopkins
Washington D.C., District of Columbia, 20016
About this study
Official title: A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule.
Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.
Read the detailed description
Degenerative spine disease is a normal part of the aging process and can cause pain and significantly limit normal movement. The most commonly diagnosed condition is Lumbar Spinal Stenosis (LSS) which presents with pain, and often weakness or numbness in the buttocks and/or lower extremities that is worsened with standing and walking. For patients that do not respond to conservative treatment decompressive surgery is indicated. When LSS is accompanied by a diagnosis of degenerative spondylolisthesis, fusion of the affected segment is often added to prevent progression of the instability that may accompany the removal of bony elements as part of the decompression. While decompression and fusion have been shown to significantly improve patient outcomes, when compared to decompression alone, fusion has been associated with several comorbidities such as adjacent level degeneration and pseudoarthrosis.
The TOPS System was designed as an alternative to fusion and is a motion preserving posterior spine implant designed to provide dynamic stabilization to a single lumbar spine segment following decompression surgery.
Patients meeting all of the entry criteria will be randomized (2:1) to receive either the TOPS System or TLIF following decompression surgery. Patients will be followed for 5 years and the composite primary endpoint will be assessed at 2 years following index surgery.
- Being tested
- Total Posterior Spine System (TOPS), Transforaminal Lumbar Interbody Fusion (TLIF)
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Posterior Spine System (TOPS)Device
Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis
Transforaminal Lumbar Interbody Fusion (TLIF)Procedure or surgery
Fusion with placement of interbody cage and posterolateral instrumentation
| Study group | Role | What they receive |
|---|---|---|
| TOPS System | Experimental | Investigational surgical treatment using TOPS System Receives: Device: Total Posterior Spine System (TOPS) |
| Transforaminal Lumbar Interbody Fusion (TLIF) | Active comparator | Control surgical treatment using interbody fusion and placement of posterolateral instrumentation Receives: Procedure: Transforaminal Lumbar Interbody Fusion (TLIF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Oswestry Disability Index (ODI)
Measured: 24 months
Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
Measured: 24 months
No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
Measured: 24 months
No subsequent surgical intervention
Measured: 24 months
Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm
Measured: 24 months
Absence of any major device related adverse event
Measured: 24 months
Secondary outcomes (3)
Greater range-of-motion through flexion-extension
Measured: 24 months
Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
Measured: 24 months
Reduction in physical component score on SF-12
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start17 Jul 2017
- Primary completion27 Jun 2022
- Study completion14 Jun 2023
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
- 305 participants (actual)
Sponsor and investigators
- Lead sponsor
- Premia Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012776
- Sponsor's protocol ID
- CL-2830 - US IDE
- Status last verified
- Jun 2024
- First submitted
- 4 Jan 2017
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Coric D, Nassr A, Kim PK, Welch WC, Robbins S, DeLuca S, Whiting D, Chahlavi A, Pirris SM, Groff MW, Chi JH, Huang JH, Kent R, Whitmore RG, Meyer SA, Arnold PM, Patel AI, Orr RD, Krishnaney A, Boltes P, Anekstein Y, Steinmetz MP. Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. J Neurosurg Spine. 2022 Sep 23;38(1):115-125. doi: 10.3171/2022.7.SPINE22536. Print 2023 Jan 1.
PubMed 36152329
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Safety and Effectiveness of the Premia Spine TOPS™ System
- ClinicalTrials.gov ID
- NCT03012776
- Acronym / sponsor ID
- CL-2830 - US IDE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 305 participants (actual)
- Lead sponsor
- Premia SpineIndustry (pharma, biotech, devices)
- Study start
- 17 Jul 2017 (actual)
- Primary completion
- 27 Jun 2022 (actual)
- Study completion
- 14 Jun 2023 (actual)
- First posted
- 6 Jan 2017 (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 trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following surgical decompression in patients diagnosed with (1) at least moderate lumbar spinal stenosis, and (2) Grade 1 spondylolisthesis (or retrolisthesis), and (3) thickening of the ligamentum flavum or scarring of the facet joint capsule.
Success will be assessed by means of a composite endpoint that measures improvement in in patient reported outcomes and the absence of any major device related complications.
Detailed description
Degenerative spine disease is a normal part of the aging process and can cause pain and significantly limit normal movement. The most commonly diagnosed condition is Lumbar Spinal Stenosis (LSS) which presents with pain, and often weakness or numbness in the buttocks and/or lower extremities that is worsened with standing and walking. For patients that do not respond to conservative treatment decompressive surgery is indicated. When LSS is accompanied by a diagnosis of degenerative spondylolisthesis, fusion of the affected segment is often added to prevent progression of the instability that may accompany the removal of bony elements as part of the decompression. While decompression and fusion have been shown to significantly improve patient outcomes, when compared to decompression alone, fusion has been associated with several comorbidities such as adjacent level degeneration and pseudoarthrosis.
The TOPS System was designed as an alternative to fusion and is a motion preserving posterior spine implant designed to provide dynamic stabilization to a single lumbar spine segment following decompression surgery.
Patients meeting all of the entry criteria will be randomized (2:1) to receive either the TOPS System or TLIF following decompression surgery. Patients will be followed for 5 years and the composite primary endpoint will be assessed at 2 years following index surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOPS System | Experimental | Device: Total Posterior Spine System (TOPS)Investigational surgical treatment using TOPS System |
| Transforaminal Lumbar Interbody Fusion (TLIF) | Active comparator | Procedure: Transforaminal Lumbar Interbody Fusion (TLIF)Control surgical treatment using interbody fusion and placement of posterolateral instrumentation |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be between 35 and 80 years of age;
- Must demonstrate at a single level to be treated (L2/3, L3/4 or L4/5) all three of the following;
- Have had at least six (6) months of failed conservative treatment prior to surgery (e.g., physical therapy, use of anti-inflammatory medications at maximum recommended dosage; administration of epidural/facet injections and/or nerve block);
- Have an Oswestry Disability Index (ODI) score of at least 40/100 at baseline;
- Have leg pain with a VAS score of at least 40/100 for at least one leg at baseline ;
Key exclusion criteria (31 listed)
- Presence of free fragment disc herniation at the index level or either adjacent level;
- Less than 4mm of disc height at the index level;
- Spondylolisthesis greater than Grade I;
- Back or non-radicular leg pain of unknown etiology;
- Stenosis caused by an extruded spinal disc fragment (e.g., herniation) or where the etiology is considered to be congenital, iatrogenic, post-traumatic, or metabolic;
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 |
|---|---|---|
| Total Posterior Spine System (TOPS)Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis | Device | TOPS System |
| Transforaminal Lumbar Interbody Fusion (TLIF)Fusion with placement of interbody cage and posterolateral instrumentation | Procedure or surgery | Transforaminal Lumbar Interbody Fusion (TLIF) |
Primary outcome
Improvement in Oswestry Disability Index (ODI)
Time frame: 24 months
Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
Time frame: 24 months
No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
Time frame: 24 months
No subsequent surgical intervention
Time frame: 24 months
Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm
Time frame: 24 months
Absence of any major device related adverse event
Time frame: 24 months
3 secondary outcomes
Greater range-of-motion through flexion-extension
Time frame: 24 months
Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
Time frame: 24 months
Reduction in physical component score on SF-12
Time frame: 24 months
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 Jun 2024.
- Derived from this study: PubMed 36152329Coric D, Nassr A, Kim PK, Welch WC, Robbins S, DeLuca S, Whiting D, Chahlavi A, Pirris SM, Groff MW, Chi JH, Huang JH, Kent R, Whitmore RG, Meyer SA, Arnold PM, Patel AI, Orr RD, Krishnaney A, Boltes P, Anekstein Y, Steinmetz MP. Prospective, randomized controlled multicenter study of posterior lumbar facet arthroplasty for the treatment of spondylolisthesis. J Neurosurg Spine. 2022 Sep 23;38(1):115-125. doi: 10.3171/2022.7.SPINE22536. Print 2023 Jan 1.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Posterior Spine System (TOPS) and Transforaminal Lumbar Interbody Fusion (TLIF) in people with Lumbar Spinal Stenosis and Degenerative Spondylolisthesis, run by Premia Spine at 36 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 10 inclusion and 31 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 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 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.
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?
Improvement in Oswestry Disability Index (ODI) (time frame: 24 months). The study lists 6 primary outcomes in all. 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 NCT03012776, 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 Jun 2024.