View clinical trials related to Spinal Diseases.
Filter by:Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects. This study will evaluate whether DEX can help get patients out of the hospital faster after major spine surgery by reducing the inflammation associated with the procedure itself. A separate part of the study will evaluate the blood levels of some specific indicators of inflammation called cytokines. Measuring cytokines before and after surgery will aid in determining if DEX has altered the inflammatory response.
The purpose of this observational study is to investigate the impact of fentanyl matrix on improvement of pain and functioning in spinal disorder-related chronic pain.
Compare two care management support program models on medical costs and utilization.
Interventional spine procedures are an increasingly popular means of diagnosis and treatment of spine disease. By convention, local anesthetics are used at the beginning of these procedures with the goal of minimizing pain. However, the infiltration of the local anesthetic is painful. This initial painful stimulus can heighten pain awareness and cause anxiety or excessive movement during the procedure. The purpose of this study is to determine patient discomfort with administration of cutaneous local anesthetic prior to interventional spine procedures compared to no anesthetic administration for different gauge procedural needles. Another purpose is to determine patient discomfort with administration of local anesthetic by traditional technique compared to an alternative technique and to develop a standardized technique and criteria for local anesthetic administration during spine injection procedures that minimizes patient pain, and may help reduce the overall risk of these procedures. We plan to enroll a total of 200-300 subjects coming to Stanford for symmetric bilateral single injections.
The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1. Overall success will be the primary clinical endpoint.
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will be examined.
The collection of data from the myriad of services described is significantly impacted by NIH guidelines defining medical research involving humans as well as the recent implementation of HIPAA constraints which further complicate the conduct of retrospective clinical outcomes research. Simple case reports or case series analysis now involve IRB participation as well as voluminous documentation. The solution to this dilemma lies in developing and promoting secure, confidential prospective clinical databases for storing clinical data for subsequent retrospective de-identified inquiry. These databases function in a way analogous to "tissue banks" for subsequent basic science research. Patients consent to prospective entry of their clinical information into the database so long as they continue to be a patient with the Department of Neurological Surgery or the Departments or Divisions in association with the affiliated programs briefly described above. The consent is obtained during the patient's first inpatient or outpatient encounter in parallel with the HIPAA consent. It can be withdrawn by request of the patient at any time, but it does not expire unless the patient withdraws it, or the patient severs their patient care relationship with UCI Neurosurgery or the affiliated programs. The database is stored on a separate secure server maintained and backed up by the UCIMC Information Technology Department. Access to the database is restricted at multiple levels, with the majority of personnel allowed only limited access for data entry purposes. Only the database programmer/coordinator, the Department Administrator and the Chairman of the Department will have unrestricted access to the database. Authority for permission for levels of security clearance and access to the database, for other individuals, will be vested in the Chairman of the Department of Neurological Surgery. A separate IRB proposal will be formulated for individual study related to the acquisition of data from the de-identified database. Since these future studies will be performed on data sets derived from the previously consented subjects of this IRB-approved project, the requirement for additional consent forms are not anticipated. As a result IRB research proposals utilizing the database can be expedited. Once the specific study is approved, the investigator(s) are provided with the clinical information from the database in the form of a de-identified data set.
The purpose of this study is to learn whether an investigational device called the Activ-L Artificial Disc is safe and effective in the treatment of degenerative disc disease of the lower (lumbar) spine.
The purpose of this study is to determine whether the early identification and more precise intervention of operating room (OR) patient fluid administration optimization using arterial pressure-based cardiac output (APCO) yields comparable patient outcome as fluid administration optimization using a global standard care method.
The purpose of this study is to measure the benefits of anterior (from the front) cervical (neck) surgery for degenerative disc disease. The research part of this study is the answering of questionnaires by the patient concerning their quality of life, prior to, and after surgery.