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Scoliosis clinical trials

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NCT ID: NCT02531945 Completed - Scoliosis Clinical Trials

Evaluation of the Surface Topography for Monitoring Scoliosis Patients Aged 10-13 Years

SCOBIOMOD
Start date: September 2015
Phase: N/A
Study type: Interventional

The main objective of the study is to investigate the correlation between the measurement of the Cobb angle (angle of scoliosis) by conventional radiography and angle measured by surface topography. The device used in this research to the topography examination is three-dimensional morphometry device of AXS Medical society : the BIOMOD L.

NCT ID: NCT02481570 Completed - Postoperative Pain Clinical Trials

Anesthetic Optimization in Scoliosis Surgery

AIS
Start date: November 2015
Phase: N/A
Study type: Interventional

The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.

NCT ID: NCT02471508 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

Safety and Efficacy of Body-mapping Tank Top Equipped With Biofeedback System for Adolescent With Early Scoliosis

Start date: June 2015
Phase: Phase 1
Study type: Interventional

Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature on spine. Spine curvature increases in youths as puberty progresses. The recommended treatment for AIS is different depends on the spine deformity condition. For mild scoliosis (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid plastic material restrict nearly all movements of the wearers, which caused irritation. Flexible brace is an alternative option, however, the efficiency of such treatment is questionable in terms of controlling the spine curvature progression. Biofeedback has proven to be effective for a number of physical, psychological and psychophysical problems. The basic aim of biofeedback therapy is to support a patient in realizing his/her self-ability to control specific psychophysiological processes. In this study, a biofeedback embedded tank-top with a specialized design for adolescents as a treatment option for AIS patients by monitoring the daily posture of the wearers.

NCT ID: NCT02465099 Terminated - Scoliosis Clinical Trials

Posterior Spinal Fusion With Two Energy Dissection Techniques

Start date: June 1, 2015
Phase: Phase 4
Study type: Interventional

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.

NCT ID: NCT02464813 Completed - Scoliosis Clinical Trials

Effect of Pregabalin on Immediate Post-operative and Longterm Pain

Start date: August 1, 2015
Phase: Phase 4
Study type: Interventional

This study aims to evaluate the incidence of longterm pain after spinal fusion surgery in children and adolescents. In the second part of the study a randomized double-blind clinical trial will be conducted. We compare the effect of pregabalin versus placebo on postoperative pain and oxycodone consumption. We will also be able to evaluate the effect of pregabalin on neurophysiological monitoring during surgery.

NCT ID: NCT02463175 Terminated - Acute Kidney Injury Clinical Trials

Effects of Goal-directed Fluid Therapy on Post-operative Outcomes in Children Undergoing Scoliosis Repair

CardioQ-RP
Start date: June 2015
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT02434003 Recruiting - Scoliosis Clinical Trials

Prospective Multicenter Evaluation of a New Predictive Model for the Progression of Adolescent Idiopathic Scoliosis

Start date: May 2014
Phase:
Study type: Observational

Scoliosis is a three-dimensional deformity affecting the orientation and position of the spine. Locally, the shape of the vertebra is also affected. The most common form is adolescent idiopathic scoliosis (AIS) with a prevalence of 1-3% affecting primarily young adolescent females. AIS can either be treated using a brace and in some cases necessitate surgical correction to prevent progressive deformity. Risk factors for progression include female gender, curve magnitude and location, skeletal maturity and growth velocity. However, these risk factors have been shown to be inconsistent in predicting curve progression. Over the past 6 years, the investigators have developed a predictive model of the final Cobb angle in AIS based on 3D spinal parameters. This analysis was based on a prospective cohort of 195 patients that were enrolled upon their initial visit and followed until maturity. This predictive model has a determination coefficient of 0.702. The proposed new study aims at refining and testing the external validity of this model in a larger cohort. The next step towards using the new model in the clinical setting is to redesign the model and to externally validate the model by measuring the agreement between the new method and the traditional Cobb angle at maturity in a larger multicenter study. The objective of this study is to characterize the risk of scoliosis progression based on local three-dimensional vertebral and pelvic measurements present on initial evaluation. Three-dimensional reconstructions will be derived from stereo-radiographs acquired with a new biplanar low-dose radiographic system installed in all 8 clinical sites (EOS system, EOS-Imaging, Paris). These calibrated radiographs will then be used to reconstruct the vertebrae and intervertebral disks at each level as well as the geometry of the pelvis. A series of local and regional parameters will then be calculated from these 3D reconstructions. Correlation analysis will help determine if intervertebral disk wedging, vertebral wedging, transverse plane rotation or pelvic geometry can be used as early predictors of curve progression in AIS. Identifying a new 3D measure of scoliosis associated with rapid curve progression could help predict which curves need early treatment to prevent further progression. The ultimate goal of this research project will be to validate this new predictive model and finally transfer this new predictive tool in the hands of clinicians treating AIS.

NCT ID: NCT02413788 Completed - Scoliosis Clinical Trials

Impact of Aerobic Training and Combined in Inflammatory Markers in Patients With Adolescent Idiopathic Scoliosis

Start date: September 2015
Phase: N/A
Study type: Interventional

Inflammatory markers have been analyzed in several diseases of unknown etiology, in the expectation of increasing therapeutic perspectives. This possibility arises from the different levels of tissue injury with low-grade chronic inflammation that have been observed in studies in which the markers were not evaluated traditionally, and today have influenced clinical management. The investigators aimed, therefore, to evaluate the inflammatory markers in patients with AIS before and after aerobic and combined exercise training.

NCT ID: NCT02412137 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

Effect of Compliance Counseling on Brace Success in Patients With Idiopathic Scoliosis

Start date: December 2007
Phase: N/A
Study type: Interventional

To measure the effectiveness of counseling on brace-wear compliance and curve progression in patients with adolescent idiopathic scoliosis. The investigators hypothesize that compliance is increased when it is measured and used to counsel patients, and therefore those patients will have less curve progression and fewer would need surgery. A second purpose is to evaluate whether there is a correlation between BMI and brace effectiveness. Proposed theories for decreased effectiveness in patients with elevated BMI have included decreased compliance due to discomfort and decreased force exerted on the curve due to the larger habitus.

NCT ID: NCT02409615 Completed - Clinical trials for Idiopathic Scoliosis

Complementary Therapies in Spinal Fusion Patients

Start date: August 2014
Phase: N/A
Study type: Interventional

In this pilot study, our central hypothesis is that two CAM modalities, hypnosis and healing touch as adjunct therapies to the standard of care, will improve analgesic use for post operative pain. In this pilot study the investigators will randomize 45 adolescents undergoing spinal fusion for idiopathic scoliosis to two test groups: Hypnosis with Pain Management Standard of Care for Post Op Pain, Healing Touch with Pain Management Standard of Care, and a control group (Pain Management Standard of Care only).