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.
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.
"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
"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
"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
"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
"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
"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
"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
"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
"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
"[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
"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
"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