View clinical trials related to Scoliosis.
Filter by:Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety
The long-term goal of this study is to optimize the perioperative care of pediatric spinal deformity patients, minimizing perioperative complications and increasing cost-effectiveness of perioperative hematologic management. The objective of the proposed study, which is the initial step in pursuit of this goal, is to evaluate the effectiveness of thromboelastography (TEG) to monitor coagulation pathways and direct blood product replacement in pediatric neuromuscular spinal deformity surgery. The central hypothesis of this study is that TEG will decrease exposure to allogeneic packed red blood cells (PRBC). The rationale is that proven effectiveness of TEG in neuromuscular deformity may change the standard of care for hematologic management in neuromuscular spinal deformity cases and additionally set the stage for a multicenter trial in idiopathic pediatric deformity.
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the rate of adverse events of interest through the 24 months follow-up visit.
The OSTEOVUE™ Spine Dissector is a new ultrasonic energy device, specifically designed for soft tissue removal from vertebral surfaces. The aim of the present study is to compare blood loss in multilevel PSF surgeries in patients with adolescent scoliosis (idiopathic or neuromuscular) done with ED or with UD. Blood loss will be estimated by major intraoperative surgical Stage (1 and 2) and postoperatively (until discharge). Additionally, the study will assess the possible influence of the device use in secondary perioperative outcomes.
Surgery for scoliosis correction, the abnormal curvature of the spine, is a major procedure often undertaken in adolescents. In adult anesthesia, there is a large volume of literature debating how to optimize fluids administered during surgery, as both too much fluid and too little fluid are associated with worse outcomes. The investigators will compare fluid administration based on the measured amount of blood pumped by the heart during each heart beat (goal-directed therapy), against standard anesthetic management. The main outcomes are a) post-surgical kidney dysfunction, b) prevalence of intraoperative hypotension, c) volumes of administered fluids, and d) length of hospitalization.
Adolescent idiopathic scoliosis (AIS) is a common disorder of unknown etiology in which the vertebrae and discs gradually develop a curvature that is first detected in patients between 11 and 20 years of age. The deformity is 3-dimensional, with a coronal curve measured from radiographs by the Cobb angle . The Cobb angle measurement of scoliosis represents the sum of the angular wedging of each vertebra and disc between the superior and inferior end vertebrae . Although a small curve is well tolerated and does not require treatment, a large curve can progress to the point that it is cosmetically unacceptable, interferes with chest wall mechanics, and produces cardiac and pulmonary compromises. The natural history of AIS apparently includes 2 stages: the initiation of the curve and its subsequent progression. The factors responsible for the initiation of the curve are unknown, but the subsequent progression of the curve is clearly associated with the adolescent growth spurt . The primary risk factors for progression include age at onset and the magnitude of the curve; young patients with large curves are at the highest risk . Although numerous treatment methods have been recommended for patients with AIS, the only accepted treatment includes bracing for skeletally immature patients with curves between 25 and 40 degrees and operative correction with spinal fusion for patients with curves greater than 45 degrees. For many teenagers, the cosmetic and social concerns associated with bracing has caused compliance problems with wearing the brace and many patients only wear the brace at home . While operative intervention completely corrects the scoliosis or rib hump, it eliminates segmental spinal motion, and concentrates stresses at the ends of the fusion potentially leading to disc degeneration and back pain. Despite satisfactory short-term results of operative instrumentation and fusion, a less invasive technique preserving more motion with a smaller scar represents a major improvement. Realizing this goal is contingent on treating curves early, before they progress to an irreversible deformity, and when there is still enough residual growth and remodeling potential. ApiFix Ltd has developed a novel implant for less invasive treatment of AIS. The MID-C system is designed to correct the deformity step by step along a period of time, giving the skeletal and soft tissues time to accommodate any incremental correction. The MID-C System inherent benefits are: - Only two screws are used - Incision size is much smaller - Simpler operation with shorter operative time - Less complications (attributed to the three points above). - Minimal spinal mobility loss. All the device components are made of materials well accepted in the orthopedic field and are fully biocompatible (see Investigator Brochure). The unique concept of the system and the materials used may provide favorable results as follows: Smaller scare, quicker healing period and better spine mobility over the years. This study is designed to demonstrate that the MID-C System is safe and effective.
The hypothesis of this study is that moderate scoliosis patients have postural and kinematic differences (static and dynamic) compared with healthy volunteers and it is possible to characterize and quantify. The aim of this study is the detailed analysis of postural anomalies in moderate scoliosis patients compared with healthy volunteers
To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients
To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).
This is a study comparing pain control utlilizing one or two epidural catheters, along with a hydromorphone PCA, for analgesia following surgery for correction of scoliosis.