Total Posterior Spine System (TOPS) for Spinal Stenosis of Lumbar Region

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of California - Irvine Medical Center, Orange, CA
Spinal Stenosis of Lumbar Region+3 More
Total Posterior Spine System (TOPS) - Device
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

A Pivotal Study of the Premia Spine TOPS™ System

See full description

Eligible Conditions

  • Spinal Stenosis of Lumbar Region
  • Spondylolisthesis, Degenerative

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Total Posterior Spine System (TOPS) will improve 6 primary outcomes and 3 secondary outcomes in patients with Spinal Stenosis of Lumbar Region. Measurement will happen over the course of 24 months.

24 months
Absence of any major device related adverse event
Greater range-of-motion through flexion-extension
Improvement (20 mm) in visual analogue scale (VAS) for back pain and worst leg
Improvement in Oswestry Disability Index (ODI)
Maintenance or improvement in Neurological status as assessed by a standard neurological exam performed by Investigator
No epidural steroid injection, facet joint injection, nerve block, or placement of spinal cord stimulator
No subsequent surgical intervention
Radiographic confirmation of fusion in control arm and non-fusion in the TOPS arm
Reduction in physical component score on SF-12

Trial Safety

Trial Design

2 Treatment Groups

Transforaminal Lumbar Interbody Fusion (TLIF)
1 of 2
TOPS System
1 of 2
Active Control
Experimental Treatment

This trial requires 266 total participants across 2 different treatment groups

This trial involves 2 different treatments. Total Posterior Spine System (TOPS) is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

TOPS System
Device
Investigational surgical treatment using TOPS System
Transforaminal Lumbar Interbody Fusion (TLIF)
Procedure
Control surgical treatment using interbody fusion and placement of posterolateral instrumentation

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 24 months for reporting.

Closest Location

University of California - Irvine Medical Center - Orange, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The text explains that in order to be treated as a person with a hearing impairment, a person must demonstrate at a single level that they have difficulty hearing at all three of the following levels: Level 2/3, Level 3/4, and Level 4/5. show original
The ligamentum flavum has thickened and/or the facet joint capsule has been scarred, as identified by the investigator based on MRI. show original
and The patient must have had at least six months of conservative treatment, such as physical therapy and medication, before surgery is an option. show original
have leg pain that bothers you a lot ; have pain that bothers you more than it does other people your age ; have pain that keeps you from doing some activities. show original
images, was present in 116/173 patients (67%) 116/173 patients had at least moderate lumbar spinal stenosis show original
and Be on corticosteroid therapy at a dosage of 10 mg/day or more of prednisone or equivalent for at least 8 weeks At baseline, have an Oswestry Disability Index (ODI) score of at least 40/100; and Be on corticosteroid therapy at a dosage of 10 mg/day or more of prednisone or equivalent for at least 8 weeks. show original
at least 1 leg with a VAS score of 3 or more points One or both legs have significantly less lower back pain than the worst leg show original
This is a condition where someone experiences pain in their leg when walking or standing, but the pain is reduced when sitting or bending forward. show original
You must be between the ages of 35 and 80 in order to apply. show original
of the lumbar spine Spondylolisthesis is a condition in which one of the bones in your spine slips out of place show original

Patient Q&A Section

What are common treatments for spinal stenosis?

"Both nonsurgical and surgery are used to treat lumbar spinal stenosis. The choice for surgery should be made with the use of a discussion among surgeons and patients based on factors such as the grade of stenosis, number of attacks of symptoms, medical condition, and coexisting injuries. The role of nonsurgical treatment of spinal stenosis remains only for selected patients without contraindications. Both nonsurgical and operative therapies are effective but there is a need for higher quality evidence in the literature." - Anonymous Online Contributor

Unverified Answer

Can spinal stenosis be cured?

"The ability to 'cure' stenosis surgically has not been established, except by demonstrating improvement. However, most patients with symptomatic stenosis need some form of intervention over the short term." - Anonymous Online Contributor

Unverified Answer

What causes spinal stenosis?

"Pain or radiculopathies are sometimes the first symptom of neurological disease, and spinal stenosis can also precede neurological signs and symptoms. Spinal stenosis is not contagious." - Anonymous Online Contributor

Unverified Answer

What is spinal stenosis?

"Spinal stenosis, a spinal condition characterized by reduced space in the spinal canal, is a progressive spinal disease that can occur in otherwise healthy and otherwise fit people. The average duration of spinal stenosis is 6 to 8 years and the symptoms usually subside by the 4th decade. In one third of cases, the condition results in debilitating symptoms. The causes of spinal stenosis are multiple, although the main cause is back fatigue associated with aging. Back pain is a very common symptom. In the United States, spinal stenosis is the most common cause of pain in women over the age of 65." - Anonymous Online Contributor

Unverified Answer

What are the signs of spinal stenosis?

"Symptoms of spinal stenosis include a decreased ability to stand, walk or sit, backache, numbness, and weakness. Patients with a large canal stenosis experience the most severe symptoms and the inability to stand, walk, or sit can only be accounted for by a canal stenosis. There exists a relation between increased spinal stenosis grade and lumbar disk herniation. In patients with severe radicular pain, a spinal stenosis grade of at least three should be considered." - Anonymous Online Contributor

Unverified Answer

How many people get spinal stenosis a year in the United States?

"Approximately 14.5 million Americans are affected with degenerative lumbar spinal stenosis. The number of people affected with degenerative lumbar spinal stenosis is increasing. This increase in degenerative lumbar stenosis is projected to increase, especially for those in their 40s and early 50s. Spinal stenosis is also seen with cervical spinal stenosis. Because of the increasing number of people affected with lumbar degenerative spinal stenosis and its increasing prevalence, spinal surgeons need to be better prepared to treat degenerative spinal stenosis due to the growing population with this disease." - Anonymous Online Contributor

Unverified Answer

Is total posterior spine system (tops) safe for people?

"This first report of the use of PS (tops) in a cohort of patients with lumbar canal stenosis has demonstrated PS (tops) to be safe when used for patients with narrowing of the lumbar canal. This is the first controlled study of PS (tops) for lumbar stenosis. The use of PS (tops) as a safe and effective treatment for canal stenosis appears a viable alternative to spine surgery in this group of patients." - Anonymous Online Contributor

Unverified Answer

Does total posterior spine system (tops) improve quality of life for those with spinal stenosis?

"Excellent clinical outcomes and high levels of satisfaction were reported in patients treated with the TPS. The authors recommend the TPS as the treatment of choice for those with spinal stenosis and related degenerative spinal canal stenosis." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets spinal stenosis?

"The prevalence of spinal stenosis was estimated [using the age-adjusted prevalence per year] as being 2.3% in women and 3.1% in men. Furthermore, of those with spinal stenosis, only 0.4% had surgery. That is, there appears to be a lack of appropriate surgical intervention on a population-level. Although our findings were based on the data from one large and one medium-sized study, these results are more representative of the natural history of spinal stenosis. In contrast, the treatment rate was found to be low. There may be different rates of spinal stenosis in different population subgroups, and we cannot exclude a skewed estimate of treatment rates for spinal stenosis." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in total posterior spine system (tops) for therapeutic use?

"[In 2010] two new implants were developed that were successful in a clinical trial, demonstrating [the efficacy of these new implants (Nucleus-7(TOPS) and Nucleus-10(TOPS)) for treating spinal stenosis (causes paralysis) with a minimum follow-up of 6 months.] The latest development in spinal fusion, the [new TOPSystem device (Mobi(TOPS) and the TOPSyte System) with autograft bone replacement (cancellous pedicle [bone] graft of the posterior spine) has shown [very high clinical evidence of effectiveness] in eliminating all clinical symptoms of the patient with minimal complications of surgery, and as of 2017, is available in America." - Anonymous Online Contributor

Unverified Answer

Does spinal stenosis run in families?

"Spinal stenosis is a common degenerative disorder that is often misdiagnosed and is poorly understood. The familial form of the condition may be a marker for mutations in the gene for laminin-2, which encodes the ligand of the C-migratory adhesion receptor. The gene is located on the short arm of chromosome 16 (16p13), close to the gene for spinal dysraphism type 3 (SPP3)." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating spinal stenosis?

"Many treatments, including the newest technology, may reduce, but will not eliminate, the symptoms of spinal stenosis. [Patient-focused interventions, including behavioral, psychological, and biomedical interventions, reduce symptoms of spinal stenosis and may even lead to positive outcomes when provided by health professionals in combination with other treatments such as physical therapy. Patients with neurological deficits secondary to spinal stenosis may benefit the most from interventions including patient education, behavioral and psychological interventions. [Finally, more stringent rehabilitation guidelines and research are needed to determine the best method of and duration of treatment for patients with spinal stenosis.] (https://www.ahr." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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