10 Clinical Trials for Various Conditions
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.
The purpose of this study is to evaluate the effect of cervical decompression surgery on the biomechanics of the lower extremities and spine during balance and gait in patients with cervical spondylotic myelopathy (CSM), before and after surgical intervention, and compare these parameters to an asymptomatic control group. To test our hypothesis that cervical decompression will improve preexisting gait disturbance, a gait analysis using dynamic surface EMG, video motion capture, and force plate analysis will be used. Patients 30 to 70 years old will be eligible for the study. Thirty subjects diagnosed with symptomatic CSM and are deemed appropriate surgical candidates, along with 30 healthy subjects with no spine pathology, will be enrolled in this study. Exclusion criteria include any history of previous lumbar/thoracic surgery or lower extremity surgery, BMI greater than 35, or currently pregnant. Each subject from the surgical group will be evaluated on 3 different occasions: 1) 1 week before surgery, 2) 3 months postoperative, and 3) 12 months postoperative. Control subject will only be evaluated once. Bilateral trunk and lower extremity neuromuscular activity will be measured during a full gait cycle using dynamic surface EMG measurements. Human video motion capture cameras will collect lumbar spine and lower and upper extremity joint angles. Ground reaction forces (GRFs) will be collected from a 5 foot stretch of force platforms in order to define a full gait cycle.
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 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
CSM (Cervical spondylotic myelopathy) is the most common cause of spinal cord injury worldwide. While there is evidence from the recently completed SpineNet prospective study that surgical decompression is an effective treatment for CSM, it is clear that many patients have remaining neurological impairment. While surgery is relatively safe, approximately 3% of patients maintain a neurological problem. Given this background and data from preclinical models of non-traumatic and traumatic spinal cord injury, there is strong evidence to consider the potential benefit of adding a neuroprotective drug which aids in the treatment of patients with CSM whom are undergoing surgical decompression. Riluzole is FDA-approved for the treatment of amyotrophic lateral sclerosis, which has some similar clinical features to CSM. Riluzole is currently under investigation for traumatic spinal cord injury. Given this background, there is a strong basis to consider studying the potential neurological benefits of Riluzole as a treatment to surgical decompression in patients with CSM.
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.
Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from rigors of military service. Balance and posturography are negatively affected in CSM, but require expensive equipment, and extensive training of personnel for data acquisition and interpretation. The Virtual Environment TBI Screen (VETS) is a simple and inexpensive construct that could be implemented as an aid in diagnosis and as an objective means to compare treatment modalities and track recovery. The goal for the SPiRE is to generate the critical data to support rigorous Merit studies of posturography for assessments of clinical course in the treatment and rehabilitation of CSM. The investigators' ultimate goal, if the SPiRE is successful, is to phase in objective posturography assessments as VA standard of care in CSM.
The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.