22 Clinical Trials for Various Conditions
The purpose of this study is to determine the relevant significance of diabetes on cervical disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile in patients undergoing anterior cervical discectomy and fusion for cervical spondylosis. Additionally, to compare the level of degenerative cervical disc glycosylation in patients with and without diabetes. Hypothesis: Patients with diabetes and degenerative cervical disc disease have higher levels of disc tissue glycosylation, and higher levels of glycosylation are correlated with poor outcomes.
The purpose of the study is to determine the cost-effectiveness of different surgical strategies to treat cervical spondylotic myelopathy. The study will use data generated from the CSM-S Trial (NCT02076113). 1. To determine if laminoplasty is more cost-effective compared to dorsal fusion or ventral fusion surgery. 2. To determine the relative cost-effectiveness between anterior cervical discectomy and fusion (ACDF), posterior instrumented cervical fusion (PCF), and cervical laminoplasty.
This study will comprehensively evaluate the outcomes and endpoints of these two different FDA-approved artificial disc implants used to treat cervical spondylotic myelopathy and/or radiculopathy today: Biomet Zimmer Mobi-C and Nuvasive Simplify. Both implants are structurally different with the Nuvasive Simplify implementing a three-piece design with two endplates and a semi-constrained mobile core while the Biomet Zimmer Mobi-C implements an unconstrained three piece design. Subjects will be age-matched and randomly assigned to either implant with informed consent. All subjects will undergo a variety of assessments that evaluate neck disability, quality of life, pain, physiological outcome (radiographic assessments), and neck range-of motion before and after their procedure. One baseline testing will be conducted along with three post-operation visits (three months, six months, and one year) in accordance to standard follow-up procedure. Thus, the duration of participation in the study will be approximately one and a half years.
The primary objective of this study is to evaluate the safety and performance of anterior cervical spine surgery using the NuVasive anterior cervical plate (ACP) System as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
A prospective, randomized, placebo controlled, double-blinded study at a single institution.
The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which represents the most common cause of spinal cord injury and dysfunction in the US and in the world. This study aims to test the hypothesis that ventral surgery is associated with superior Short Form-36 physical component Score (SF-36 PCS) outcome at one year follow-up compared to dorsal approaches and that both ventral and dorsal surgery improve symptoms of spinal cord dysfunction measured using the modified Japanese Orthopedic Association Score (mJOA). A secondary hypothesis is that health resource utilization for ventral surgery, dorsal fusion, and laminoplasty surgery are different. A third hypothesis is that cervical sagittal balance post-operatively is a significant predictor of SF-36 PCS outcome.
More than half of the middle-aged population has radiologic evidence of cervical spondylosis (Irvine 1965) and a subset of this population develops cervical spondylotic myelopathy (CSM), a condition in which the spinal cord is impaired, either by direct mechanical compression or indirectly by arterial deprivation and/or venous stasis. In this study we aim to test the hypothesis that diffusion tensor imaging can provide prognostic information on the integrity of the spine in these patients which is unavailable from conventional MRI images
DTRAX Graft is used to relieve nerve pressure in the neck in order to provide relief for Cervical Degenerative Disc Disease. This study is being conducted to determine the effectiveness of the graft, and to find out whether or not it provides better results or faster healing than traditional ways of performing surgery for Cervical Degenerative Disc Disease.
Cervical collars are commonly used to provide external immobilization after elective Posterior Cervical Laminectomy and Interbody Fusion (PCLIF). The rationale for collar use is the perception and assumption that it can prevent early instrumentation failure and promote successful spinal fusion. However, there are a number of potential complications associated with cervical collars such as skin breakdown, ulceration, neck pain, impedance upon activities of daily living, and impaired swallowing. Considering these conflicting factors, there is wide disagreement among spinal surgeons about the utility, benefits, and necessity of collar use following elective PCLIF. Hypothesis: Wearing a cervical collar for 12 weeks after posterior cervical laminectomy and instrumented fusion will not demonstrate substantial benefits as measured by the incidence of instrumentation failure, rate of nonunion, or clinical outcome measures. Specific Aim I: To compare the outcomes of surgery in patients who will wear a cervical collar for 12 weeks following surgery versus those who will have the collar removed prior to discharge after surgery.
The goal of this randomized control trial is to collect sufficient preliminary data on the efficacy of sodium chloride, hereafter referred to as "saltwater" or "saline" in reducing the difficulty of swallowing following multi-level anterior cervical discectomy and fusion (ACDF) procedures. The study population will consist of generally healthy adults ages 18 - 80. The main question it aims to answer is: If the symptomatology and severity of swallowing difficulties following ACDF surgery can be reduced by gargling with warm salt water. Researchers will compare the control and interventional arms to see if the proposed intervention of gargling with warm salt water improves difficulty swallowing following surgery. Patients in the control arm will be asked to: - Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively). Patients in the experimental/interventional arm will be asked to: * Complete three (3) questionnaires at specified intervals (preoperative, postoperative day (POD) 1, 2, and 7; and at 1-month postoperatively). * Gargle with a warm saltwater solution once on POD 0, and thrice daily from POD 1 to POD 7.
Study Purpose: This study is intended to monitor outcomes for 1 year following cervical TFESI. Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion, we conservatively estimate a study enrollment period of 18 months and a total period of 2.5 years from enrollment to final follow-up data collection. If the study were to theoretically start enrolling in July 2019, we would anticipate completion by February 2022. Objectives: 1. Determine the proportion of patients with an 80% or greater improvement in arm and neck numerical rating scale pain (NRS) score following an initial cervical transforaminal steroid injection (TFESI) at 4 weeks post-injection and the duration of response up to 12 months. 2. Determine the proportion of patients with a 50%-79% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 3. Determine the proportion of patients with less than 50% improvement in arm and neck NRS score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 4. Determine the proportion of patients with an initial injection plus up to 3 additional injections that maintain 80% or greater, as well as 50-79%, improvement in arm and neck NRS score for up to 12 months. 5. Determine the proportion of patients with a clinically significant change in function defined by a minimally clinically significant change (MCIC) (≥10 point improvement ) or 30% improvement in Neck Disability Index (NDI) score following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 6. Determine the proportion of patients with clinically significant improvement in the Medication Quantification Scale (MQS III) score (≥6.8 point change , equivalent to 10 oral morphine equivalents ) following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 6. Determine the proportion of patients with clinically significant improvement in the categorical EuroQol 5 Dimensions tool (EQ-5D) defined by ≥0.03 following an initial cervical TFESI at 4 weeks post-injection and the duration of response up to 12 months. 7. Compare patient demographic, clinical, and imaging characteristics between response groups and perform predictive modeling to better understand variables that increase the likelihood of a successful clinical outcome. 8. Report adverse effects.
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
The purpose of this single-center, prospective, randomized study is to determine the fusion rates along with the clinical outcomes of commercially available bone graft substitutes Actifuse mixed with bone marrow aspirate (BMA) versus autograft mixed with demineralized bone matrix (DBM), in subjects who require anterior cervical corpectomy (ACC) spinal fusion in patients experiencing cervical spondylotic myelopathy (CSM).
The investigators propose a prospective study, designed to analyze the efficacy of High-Resolution Diffusion Tensor Imaging for accurately sensing white matter tracts in subjects with spinal cord injury. Study subjects will not be randomized, as treatment will follow the doctor's "standard of care." Patients will be selected and offered enrollment based upon the clinical diagnosis of spinal cord injury, either due to degenerative disease or trauma. Enrollment will be based on the chronology of patient presentation.
The purpose of this research is to determine if post-operative cognition will be better if the general anesthesia for surgery is done with an inhaled (gas through a breathing tube) or intravenous (medicine injected in the IV) general anesthetic technique.
The study is a prospective, first-in-human, multi-center, non-randomized, single-arm study to assess the safety and efficacy of the CEM-Cage used with the CEM-Plate in patients who are appropriate candidates for a 2-level anterior cervical discectomy and fusion (ACDF). Fifty patients will be enrolled in the study and, after undergoing a 2-level ACDF, will be evaluated at 4 weeks, 3 months, 6 months, 12 months, 18 months, and 24 months.
The purpose of the study is to determine the optimal surgical approach (ventral versus dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM). There are no established guidelines for the management of patients with CSM, which slowly causes spinal cord injury in afflicted patients. This study aims to test the hypothesis that ventral surgery (decompressing the spinal cord from the front of the neck) and dorsal surgery (decompressing the spinal cord from the back of the neck) might differ in their overall outcome or major complication rate.
The primary purpose of this study is to compare anterior and posterior surgical approach in treatment of CSM in terms of surgical complications and neurological, functional, disease-specific and quality of life outcomes measures. Secondary aims are to quantify the amount of change pre and post-surgery concerning the same outcome measures; to determine if there are differences in outcomes between posterior surgical techniques (i.e. laminectomy with fusion or laminoplasty) and examine the relationship between baseline MRI and baseline and follow-up neurological and functional outcomes.
Patients who have been diagnosed with Cervical Spondylotic Myelopathy will be asked to undergo an MRI using diffusion basis spectrum imaging (DBSI) technology. The patients will have this MRI preoperatively and at 24 months postop. The investigators believe that with this imaging, biomarkers will be able to be seen to assist in prediction of long term outcomes in patients with spinal cord compression. These patients will be compared to healthy cohorts who will also undergo an MRI using the DBSI technology.
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
Opioid overdose suppresses brainstem respiratory circuits, causes apnea, and may result in death. Epidural electrical stimulation (EES) at the cervical spinal cord facilitated motor activity in rodents and humans, and we hypothesized that EES of the cervical spinal cord could antagonize opioid-induced respiratory depression in humans. In this study, we will stimulate the spinal cord during surgery and assess its effects on respiratory function in human patients.
To quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery (MIS) for adult patients with lower back degeneration, in comparison a matching group of control patients operated in a minimally invasive approach whether freehand or with image guidance or navigation techniques.