Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical...
Cervical Degenerative Disc DiseaseDegenerative Spondylolisthesis1 moreThe purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) at 2 or more adjacent cervical vertebral levels between C3-C4 to C7-T1. All subjects in this study will undergo 2 or 3 level anterior cervical discectomy and fusion with anterior cervical plate fixation.
A Prospective Pilot Study of the OP-1 Putty in Uninstrumented Posterolateral Fusions
Degenerative Lumbar SpondylolisthesisThis study will explore the use of OP-1 Putty in conjunction with surgical treatment for the treatment of spinal decompression and lumbar spinal fusion.
Spine Fusion Instrumented With BMP-2 vs Uninstrumented With Infuse BMP-2 Alone
Degenerative Lumbar Disc DiseaseSpondylolisthesis1 moreThe 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.
Bilateral Erector Spinae Plane Block Versus Local Anesthetic Infiltration for Perioperative Analgesia...
PainPostoperative2 morePostoperative pain still represents an important perioperative issue, affecting more than 80% of patients undergoing surgery. A suboptimal pain management doesn't just affects quality of life, but can compromise rehabilitation plan, increase morbidity and determine the development of chronic pain. Last but not least, far from being just an obligation for physicians, a good analgesia is a fundamental right of every patient. In order to meet these important demands, a great number of guidelines has been provided, all of these underlying that the centerpiece of postoperative analgesia lies in the multimodality management, thereby combining different medications and different ways of delivering them, with the aim of targeting distinct receptor systems and improving efficacy, while limiting side effects. In 2018, the investigators conducted a case-series analysis on 17 patients undergoing lumbar surgery to find out the role of Sublingual Sufentanil Tablet System (SSTS) in a multimodal analgesia regimen. Patients expressed a good pain relief, with most benefit during physiotherapy sessions and early discharges, in absence of side effects. Since then, SSTS has been part of regular clinical practice in our hospital. The aim of this randomized trial is to examine the analgesic efficacy and the opioid sparing role in spine surgery of a recently developed regional anesthesia technique, the Erector Spinae Plane block (ESP block), as opposed to Local Anaesthetic (LA) wound infiltration. The latter is a widespread, simple and unexpensive mean of providing postoperative analgesia. On the other hand, ESP block is an ultrasound-guided interfascial plain block, in which LA is injected below the erector spine muscle, closer to costotransverse foramina and origin of dorsal and ventral rami. It does provide an efficient multidermatomal sensory blockade (according to craniocaudal LA spread), with the advantage of being simple and safe.
Instr. vs. Non-instr. Posterolateral Spinal Fusion in Patients With Spinal Stenosis and Degenerative...
Spinal StenosisSpondylolisthesis Degenerative1 moreThe aim of this study is to determine, in patients with grade 1 degenerative spondylolisthesis with spinal stenosis, if decompression and lumbar spinal fusion with, or without supplementary pedicle screw fixation yields an improved patient reported outcome.
Retrospective Study With Patients Treated With STALIF® C or M and Ti or FLX Implants for 1 and 2...
Degenerative Disc DiseaseGrade 1 Spondylolisthesis2 moreThis is a Retrospective, Observational Multi-Center study, utilizing patients diagnosed with up to a Grade1 spondylolisthesis or retrolisthesis or symptomatic degenerative disc disease and treated with STALIF® C, or M, Ti and/or FLX implants at one or two levels.
Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP
Low Back PainSpondylolisthesisThe first purpose of this study is to define parameters of the trunk neuromuscular functions that are pathologically altered in patients with low back pain due to spondylolytic spondylolisthesis. The second and also the main purpose of the study is to examine the effects of exercise intervention on patients with low back pain due to spondylolytic spondylolisthesis. Our overall hypothesis is that specific exercise intervention will improve neuromuscular functions of the trunk in patients with low back pain due to spondylolytic spondylolisthesis.
Assessment of nanOss Bioactive 3D in the Posterolateral Spine
Degenerative Disc DiseaseSpinal Stenosis1 moreSpine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used. However, complications can develop when the bone graft material used is insufficient to achieve the desired fusion. With its unique properties, nanOss Bioactive 3D can be mixed with bone marrow aspirate (BMA) and autograft bone to obtain new bone growth during the healing process. nanOss Bioactive 3D is approved for use in the U.S., however, additional information is useful to assess its efficacy in the posterolateral spine. The purpose of this study is to assess fusion results in the posterolateral spine using nanOss Bioactive 3D mixed with autograft bone and BMA. It is hypothesized that the use of nanOss Bioactive 3D will result in fusion at 12 months, with CT evidence of bridging trabecular bone, less than 3mm of translational motion, and less than 5 degrees of angular motion.
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
Disc Degenerative DiseaseSpondylolisthesis4 moreThe primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
Spine Patient Outcomes Research Trial (SPORT): Degenerative Spondylolisthesis With Spinal Stenosis...
SpondylolisthesisSpinal Stenosis1 moreThis study tests the effectiveness of different treatments for the three most commonly diagnosed conditions of the lower backbone (lumbar spine). The purpose is to learn which of two commonly prescribed treatments (surgery and nonsurgical therapy) works better for specific types of low back pain. In this part of the study, we will treat patients with spinal stenosis (a narrowing of spaces in the backbone that results in pressure on the spinal cord and/or nerve roots) caused by degenerative spondylolisthesis (a condition in which one vertebra, or spinal bone, slips forward on another) with either surgery or nonsurgical methods. This study does not cover the cost of treatment.