View clinical trials related to Spinal Stenosis.
Filter by:This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with MasterGraft Resorbable Ceramic Granules (Medtronic Sofamor Danek USA, Inc.) compared to autograft in patients requiring posterior lumbar interbody fusion with NuVasive's radiolucent PEEK OPTIMA cage (to be used with autologous bone graft material) and 1 or 2 level posterolateral lumbar fusion surgery with instrumentation. The instrumentation used for this study will be the Monarch® 5.50 mm Spine System (DePuy).
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
The Long-Term Outcomes Study (LTOS) is a multi-center longitudinal cohort study of all patients who received the X-STOP device in the Pivotal Trial, Continued Access Protocol (CAP), or Cross-over Study (COS). It is designed to supplement postmarket safety and effectiveness data to be gathered in a Condition of Approval (CoA) study of a population of patients with moderately impaired physical function who elect to undergo X-STOP surgery.
This randomized clinical trial pilot study will investigate the efficacy of different amounts of total treatment dosage over six weeks in 60 volunteer subjects with lumbar spinal stenosis. Subjects will be evenly randomized into four groups of either flexion distraction (FD) care or a control: Group 1 with 8 total FD treatment visits, Group 2 with 12 total FD treatment visits, Group 3 with 18 total FD treatment visits, or Group 4 with 8 total placebo control visits. The study is designed: (1) To determine the feasibility of a larger scale study in terms of logistics, recruitment efforts, and sample size estimations and (2) To determine among the three treatment groups the change in perceived pain levels and general functional health status at the end of six weeks of treatment and at three months post care as follow-up.
The purpose of this study is to gather information on the effectiveness of a new spine implant for patients who require spinal fusion surgery. Based on this information, we hope to create a standard of good performance, or benchmark, against which future studies on this spine implant can be compared. By creating this benchmark we hope to improve care for patients who require spinal fusion surgery.
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal claudication, that results from moderate or severe lumbar spinal stenosis at one vertebral level between L3 and L5.
The goal of spinal fusion is to relieve pain and/or increase stability in painful or unstable spine joints. A patient may or may not receive rods and screws with the use of bone graft materials to facilitate bone growth and a fusion thus preventing movement of the bones of the spine. In this research study, bone graft substitute material called Bone Morphogenetic Protein-2 known as BMP-2 Infuse will be used. No hip bone will be used. The surgical procedure will consist of BMP-2 Infuse with or without the use of rods and screws.
The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.
Individuals who undergo spine surgery often have a significant loss of blood and may require multiple blood transfusions. Research has shown that epsilon-aminocaproic acid (EACA) may reduce the amount of blood lost during surgery, which would decrease the number of blood transfusions required. This study will evaluate the safety and effectiveness of EACA at reducing blood loss and the need for blood transfusions in individuals undergoing spine surgery.
The purpose of the study is to determine the proper use of lower back screws and rods (instrumentation) and bony fusion in subjects with one level of degenerative spinal narrowing (stenosis) compressing nerves to the legs with one spinal bone slipping forward on another (spondylolisthesis). There are two types of operations that surgeons perform for this problem. Some spinal surgeons remove some bone in the back (laminectomy) to decompress the nerves. Other surgeons perform a laminectomy (decompression) as above, but feel that it is also important to strengthen the back by placing screws and rods into the spine and adding more bone to obtain a new bridge of bone away from the nerves (decompression with instrumented fusion). This study aims to test the hypothesis that adding instrumented fusion to a decompression for this spinal problem will improve long term patient outcomes.