View clinical trials related to Spine Fusion.
Filter by:The present study is planned to demonstrate the efficacy and safety of a new pedicle screw system for the specific indication of isthmic spondylolisthesis, as this condition concerns relatively young patients requiring good fixation of the performed reposition to come to satisfactory clinical results.
Older people are a rapidly growing proportion of the world's population and their number is expected to increase twofold by 2050. When these people become patients that require surgery, they are at particular high risk for postoperative delirium (POD), which is associated with longer hospital stays, higher costs, risk for delayed complications and cognitive dysfunction (POCD). Having suffered an episode of delirium is furthermore a predictor of long-term care dependency. Despite these risks, an increasing number of elderly undergo major elective surgery. This is reflected by the frequency of elective spinal surgery, in general, and instrumented fusions, in particular, which has markedly increased over the past few decades. It is yet insufficiently understood, which, particularly modifiable, factors contribute to the development of POD and POCD following these major but plannable surgeries. A better understanding of risk factors would facilitate informed patient decisions and surgical strategies could be tailored to individual risk profiles.
The United States (US) faces a crisis of pain management. According to the 2012 National Health Interview Survey, almost 50 million adults in the US reported having significant chronic or severe pain (Nahin 2015). Doctors in the US still prescribe opioids across the board for pain despite a growing recognition of an epidemic of opioid overdose and use disorder. Few solutions have been successfully proposed and implemented. Placebos represent a novel and potentially fruitful means of addressing this issue. However, clinicians often use placebos deceptively and with little rationale or evidence of benefit, making their use ethically problematic. In contrast with their typical current use, a provocative line of research suggests that placebos can be intentionally exploited to extend analgesic therapeutic effects. Recently, we reviewed a database of placebo studies including 22 studies in both animals and humans hinting of evidence that placebos may work as a dose extender of active painkillers. Placebos given after repeated administration of active treatments can acquire medication-like effects based on learning mechanisms. Here, we will test if dose-extending placebos are effective in relieving clinical acute pain in opioid patients with traumatic pain. Patients will be randomized to three arms. Arm 1 will be a Full Dose (FD) group, which will receive all NSAIDs as described in the Guidelines for NSAID use in Orthopedic Patients and Oxycodone (5mg). Arm 2 will be a Partial Reinforcement (PR) group, which will receive NSAIDs, Oxycodone (5mg), and placebos to reach a 50% reduction of the total intake of opioids. Finally, Arm 3 will be a Control (C) group receiving NSAIDs and placebos. Patients will be assigned to one of three arms according to a 1:1:1 schedule of randomization. Study IDs will be generated by the pharmacy and blinding will occur by ensuring that oxycodone and placebos look, smell, and taste identical. Rescue therapy will be provided as needed. This novel prospect of placebo use has the potential to change our general thinking about painkiller treatments, the typical regimens of painkiller applications, and the ways in which treatments are evaluated.