Clinical Trials Underway for New Treatment for Lumbar Spinal Stenosis Patients
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 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.
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.
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.
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