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Clinical Trials Underway for New Treatment for Lumbar Spinal Stenosis Patients
Do you feel aches and pains in your lower back, especially after sitting or sleeping? Many physically active as well as aging individuals do, and most often, it's nothing particularly serious to be worried about. However, for others, lumbar spinal stenosis can very well impede activities of daily living and have a detrimental effect on quality of life.
Defining Causes of Lumber Spinal Stenosis
Lumber spinal stenosis is a condition of the spine that causes a narrowing of the spinal column, which in turn places pressure against the spinal cord. When nerves in spinal cord are compressed or squeezed, you’ll definitely feel it. Numerous symptoms are common, including localized pain, and (depending on the location and function of the nerves), numbness in the back, the legs, the shoulders, the upper arms or even your neck. Muscle weakness and instability are common, as is interference with bodily functions including bladder and bowel control, balance, and stability.
Lumbar spinal stenosis is often caused by the wear and tear of gradual aging. This leads to gradual deterioration of spinal discs and/or joints in the spine. The condition is also caused by osteoarthritis in the lower or lumbar spinal region, which wears away cartilage between joints, causing either bony spurs or leads to the bone edges grinding against each other with movement.
Lumbar spinal stenosis may also be caused by a previous traumatic lower back injury (sports, accidents, and falls), fractures, and other conditions such as cancer, fibrosis and spondylolysis, which defines defects or fractures in part of a vertebra.
Traditional Treatment Give Way to New Technologies
Nonsurgical treatment options have included physical therapy, as well as low or non-impact exercises to increase the strength and flexibility of the lower spine. Changes in lifestyle and activities may also be recommended. Some lumbar spinal stenosis patients benefit from epidural injections of anti-inflammatory steroids, including cortisone, which helps reduce swelling of tissues against the nerves.
Surgical options depend on the severity of the spinal stenosis in the lumbar region. A spinal decompression or lumbar laminectomy procedure removes a small portion of the lamina, a section of the vertebral arch, and trims facet joints to give more room to compressed or squeezed spinal nerve roots.
Spinal fusion surgery uses small pieces of bone fragment that are fused along the narrowed portions of the lumbar spinal column. These bone fragments, when fused to existing bone structures in the spinal column, increased stability. However, this technique often reduces range of motion and mobility for the patient.
The Future of Lumbar Facet Joint Replacement Improves Quality of Life
The newest technology in the treatment of lumbar spinal stenosis is the facet replacement implant system, designed to allow anatomically correct reconstruction of facet joints after decompression procedures or removal of damaged or destroyed facet joints. The replacement implant has been designed to substitute the original facet joint, enabling "normal" facet joint motion and mobility while at the same time promoting optimal stability.
Clinical trials are underway in the study of the ACADIA™ Facet Replacement System to determine the efficacy of this method, sponsored by Globalist Medical. The primary objective of the study is to compare, evaluate and assess success rate of the anatomic facet replaces system compared to posterior spinal fusion control procedures in patients diagnosed with lumbar spinal stenosis. The clinical trials are currently in Phase 3, gathering information regarding effectiveness and safety of the procedure. The study, which began in October 2006, is estimated to conclude in October 2013
Is fusing components of the lumber spine more effective in treating lumbar spinal stenosis than the new facet replacement system? Results of the study will be announced upon its completion. The facet replacement system is designed to be anatomically available in a reproducible surgical technique that eliminates pain, allowing surgeons to remove sections of damaged bone while still preserving facet joint motion and mobility.
Individuals engaged in the study range in age from 21 to 85 years old.
Candidates for the facet replacement system are those who have been diagnosed with lateral recess, lateral, or central canal stenosis in the lumber or lower spine, and have undergone a minimum of six months of non-surgical treatment.
Benefits & Costs for Consumers
Spinal pain and weakness severely limits mobility, range of motion, and for some, quality of life. The natural aging process may affect the structure and support in the lumber spine. Lumber spinal stenosis treatments or surgical procedures reduce pain, increase mobility and range of motion, and optimally, strengthen the support structures in the lower spinal column. The facet joint replacement system is designed to do just that, especially beneficial to those in their 50s or 60s or to younger individuals who have experienced spinal damage due to trauma, extreme sports, or falls.
The newest technology incorporating the ACADIA™ Facet Replacement System is not yet offered as a proven lumbar surgery option. Determinations will be made following the conclusion of the clinical trials in October 2013, but results to date have shown increased efficacy and success.
Cost of the procedure has not yet been determined. The cost of lumbar spinal stenosis treatments or surgeries depend on geographical location, the severity of the condition, the current age and overall physical health and wellness of the individual diagnosed with spinal stenosis, and other factors including treatment or technique recommended for optimal results.
In the United States, cost of a traditional lumbar decompression or laminectomy procedure can exceed $85,000. Patients traveling to India may enjoy the same procedure for thousands of dollars less. Traditional lumbar spinal fusion procedures average about $50,000-$60,000 in the U.S., though travelers visiting countries in Latin America may pay approximately $45,000 for the entire procedure, start to finish.
PlacidWay Promotes Independence and Quality of Life
PlacidWay, an international medical resource and provider based in Denver, Colorado, focuses on providing patients, regardless of origin, accessibility to affordable spine care technologies, treatments, procedures and surgeries. Staying abreast of new technologies and options in spine surgery enables them to pass this knowledge and resources for affordable medical care to consumers. PlacidWay provides consumers with reliable, up-to-date information regarding spinal care, treatments, technologies, and facilities. For more information regarding lumbar spine surgeries and procedures that increase movement, mobility and quality of life, visit PlacidWay.com.
2013-07-29 / Updated on: 2021-01-08