View clinical trials related to Spondylosis.
Filter by: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.
Spondylolysis, a stress fracture in the pars interarticularis of a lumbar vertebra, is the most common identifiable cause of low back pain (LBP) in adolescent athletes, occurring in 14-30% of athletes who experience LBP. Spondylolysis can cause significant pain and disability and months of exclusion from sports or an active lifestyle. Standard care of spondylolysis in adolescent athletes is primarily based on expert opinion, with dramatic variations in clinical practice, including restrictive bracing, extended rest periods before the intervention, long durations out of sport and activity, and suboptimal long-term clinical outcomes. As the next step towards our research goal, the overall objective of this pilot study is to perform a pilot randomized controlled trial to assess a novel rehabilitation strategy, the immediate functional progression program (IFPP), for treating active spondylolysis in adolescent athletes. Participants randomized to the IFPP group will begin physical therapy immediately (<1 week) after diagnosis. In contrast, those in the standard care group (control) will not start physical therapy until their pain has resolved. Aim 1 will evaluate the effects of the IFPP on outcomes (Function, Pain, Quality of Life, and Edema on MRI) among adolescent athletes with an active spondylolysis. Aim 2 will assess the feasibility of performing a full randomized trial using the novel IFPP to treat athletes ages 10-19 with an active spondylolysis. Aim 3 will compare the tolerability of the IFPP to standard care. This pilot study will lay the necessary groundwork to perform a larger hypothesis-driven randomized controlled trial.
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar interbody fusion (LIF) by means of an intra-patient control model.
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.
The present study aims to adapt and modify a brief presurgical Acceptance and Commitment Therapy (ACT) intervention aimed at preventing the transition to Chronic Post-Surgical Pain (CPSP) and reducing long-term opioid use. Investigators will then assess the acceptability, feasibility, and preliminary efficacy of the finalized intervention to prevent the transition to CPSP and reduce post-surgical opioid use six months following lumbar spine surgery. Finally, investigators will identify psychosocial and psychophysical phenotypes associated with response to this intervention.
To use advanced imaging techniques, including MRI Brain and Spinal Cord, and MRI/PET Spinal Cord to provide an assessment of Degenerative Cervical Myelopathy to improve understanding of the pathophysiology and natural history of DCM.
The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in standalone ALIF procedure L5/S1
International, prospective, single arm, multicenter and observational Post-Market Clinical Follow-up (PMCF). The overall objective of this study is to collect preoperative, intraoperative and postoperative (at 9 weeks, 6 months, 1 year and 2 years) data on the clinical complications and functional outcomes of the study devices to demonstrate safety and performance in a real-world setting. The primary objective is to demonstrate that the use of the study devices is safe. The secondary objective is to demonstrate that the use of the study devices decreases the pain, and improves the quality of life and the daily activities of the subjects.
Opioid overuse is a widespread public health crisis in the United States with increasing rates of addiction and overdose deaths from prescription opioids. Reducing the need for opiate analgesics in the post-operative setting has become a high priority in minimizing long-term opioid use in surgical patients. This study will serve to demonstrate the efficacy of the addition of regional analgesic techniques in reducing post-operative opioid requirements in patients undergoing common lumbar spinal surgical procedures.
The purpose of this study is to compare the efficacy, safety and imaging outcomes between Anterior Controllable Antedisplacement and Fusion (ACAF) and Laminoplasty in the treatment of severe ossification of cervical posterior longitudinal ligament.