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Scoliosis clinical trials

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NCT ID: NCT01820845 Completed - Scoliosis Clinical Trials

Accuracy of Pleth Variability Index (PVI) in Children

PVI
Start date: December 2012
Phase: N/A
Study type: Observational

Plethysmographic Variability index is a simple index accurate in predicting fluid responsiveness. The aim of this study was to investigate its accuracy in predicting fluid response to intravenous fluid challenge during scoliosis surgery in children.

NCT ID: NCT01813058 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

Does Tranexamic Acid Decrease Blood Loss in Pediatric Idiopathic Scoliosis Surgery?

Start date: January 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Adolescent idiopathic scoliosis surgery is an extensive procedure associated with significant blood loss frequently requiring the transfusion of blood. Tranexamic acid (TXA) is a synthetic antifibrinolytic (prevents breakdown of the blood clot) that has been used to extensively reduce transfusion in pediatric major surgery, including cardiac, craniofacial and orthopedic surgery. In this prospective randomized double-blinded study, the investigators wish to evaluate the hypothesis that TXA is more effective than standard of care at decreasing blood loss and blood transfusion perioperatively in children and adolescents undergoing idiopathic scoliosis surgery.

NCT ID: NCT01803256 Completed - Scoliosis Clinical Trials

Possibilities and Limitations of a New Method for the Measurement of Spine Dynamics During Gait

Start date: April 2013
Phase: N/A
Study type: Observational

The full body marker sets that are typically used in opto-electronic 3D gait analyses either disregard the spine entirely or regard it as a rigid structure. Therefore, the purpose of this study is to identify the possibilities and limitations of an enhanced trunk marker set for the measurement of spine dynamics during gait in adolescents with and without structural spine deformities. It has been hypothesized that the enhance trunk marker set: 1. is a valid method for the measurement of spine deformations in the sagittal, frontal and indirectly transverse planes. 2. is an applicable and reliable method for the measurement of spine dynamics during gait in healthy adolescents and in patients with structural deformities such as seen in scoliosis. 3. is sensitive enough to distinguish the spinal movement pattern during gait measured in scoliosis patients from the one measured in healthy adolescents. To verify the hypotheses, the following measurements will be carried out: - Biplanar radiographs (a-p and lateral) with radio-opaque markers in scoliosis patients. - Instrumented gait analysis with a standard full body marker set and the enhanced trunk marker set in scoliosis patients and healthy controls.

NCT ID: NCT01795495 Completed - Clinical trials for Idiopathic Scoliosis

Methadone vs Magnesium in Spinal Fusion

Start date: September 2013
Phase: Phase 2
Study type: Interventional

Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia. If detected, a significant reduction in opioid requirements may lead to improved patient satisfaction and decreased opiate side effects. The current study would use a prospective, randomized trial investigating the efficacy of one of 2 regimens as adjuncts to intraoperative anesthesia and postoperative analgesia, along with a third control group. The patients would be randomized to receive remifentanil plus a single intraoperative dose of methadone; remifentanil plus a bolus followed by an infusion of magnesium; or remifentanil alone. In addition, the two medications being studied might make it easier to determine the efficacy of neurophysiologic monitoring including somatosensory evoked potential (SSEP) (amplitude and latency) and motor evoked potential (MEP) (mA) required to elicit the response. The purpose of this study would be to explore the effects of intraoperative methadone vs magnesium on intraoperative anesthetic requirements, postoperative opioid requirements, the efficacy of neurophysiologic monitoring including SSEP and MEP, inspired concentration of desflurane, remifentanil, and the need for intraoperative supplemental agents to control blood pressure.

NCT ID: NCT01792609 Completed - Scoliosis Clinical Trials

Min Implants Max Outcomes Clinical Trial

MIMOCT
Start date: April 18, 2013
Phase: N/A
Study type: Interventional

Objectives Primary objective: Determine if there is a clinically significant difference in percent Cobb curve correction in a low- vs. high-implant density cohort through a prospective randomized controlled trial. Design and Outcomes Randomized clinical trial of equivalence to test the efficacy and safety of low vs. high implant density instrumentation for spine deformity surgery in AIS patients with Lenke IA curve patterns. Interventions and Duration Intervention: low-implant density group or high-implant density group. Duration: 2 years. Sample Size and Population Target population: 10 to 17 years old with AIS who will undergo instrumented spinal fusion. Sample size needed (power = 90%) is 174 subjects with 87 in each group.

NCT ID: NCT01776736 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

Safety and Efficacy of Posture Correction Girdle for Adolescent With Early Scoliosis

Start date: July 1, 2012
Phase: N/A
Study type: Interventional

For AIS, the caring of patients with spinal deformities has a long and varied history. Severe spinal deformities can greatly reduce pulmonary and cardiac functions, which may lead to death from cardiopulmonary failure. Therefore, surgery is generally suggested when the curvature of the spine is greater than 45-50 degrees. The adverse psychological impact of orthoses treatment on patients and its poor compliance has been a well-recognised problem. Some orthotic research studies indicate that early intervention of spinal deformities is particularly desirable. Taking into consideration current clinical practices, if the curve is less than 20 degrees, even if the child is at a high risk of progressive spinal deformity during the age of 10-16 at puberty, treatment is nothing more than just observation. This project aims to combine clinical experience with textile and materials sciences to research and develop a posture correction girdle for adolescents with early scoliosis. As a result, this will reduce the future likelihood of brace wear or surgery. In this study, the eligible subjects will be given tailor-made posture correction girdles to wear it 8 hours daily. Monitoring and observation will be provided during the six months girdling period. Data will be collected before and after the girdling by X-ray radiograph for analysis, in order to comparison the spine curvature condition. Locomotion of the subject with and without wearing the posture correction girdle will also be reference.

NCT ID: NCT01776125 Completed - Scoliosis Clinical Trials

Genetic Evaluation of NF1 and Scoliosis Patients

Start date: August 2010
Phase:
Study type: Observational

Neurofibromatosis (NF) is a common genetic disorder that cause tumors to grow along various types of nerves and, in addition, can affect the development of bones and skin. It occurs in 1:4000 persons. NF has been classified into three distinct types: NF1, NF2 and Schwannomatosis. NF1 is the focus of this study. NF1 is an extremely variable disorder which ranges from extremely mild cases in which the only signs of the disorder in adulthood may be multiple café-au-lait spots and a few dermal neurofibromas, to more severe cases like disfigurement, scoliosis and learning disabilities. Scoliosis (abnormal curvature of the spine) is perhaps the most common bone deformity in NF1 which usually appears in early childhood. There are two types: dystrophic and non-dystrophic scoliosis. Dystrophic scoliosis is usually associated with other bone deformities which are seen on x-ray and carries a poorer prognosis than non dystrophic scoliosis. There is evidence that genes other than the NF1 gene are responsible for the variable severity of cases. Recent studies have identified genetic markers for another condition called adolescent idiopathic scoliosis (scoliosis which presents in adolescent age group with no known cause). We believe that the same genetic markers may also be present in NF1 patients with scoliosis. Our objective is primarily to determine if the same genetic markers discovered in adolescent idiopathic scoliosis are also present in NF1 patients with scoliosis.

NCT ID: NCT01772459 Completed - Adolescent Clinical Trials

Paper vs. Internet

P vs I
Start date: August 2010
Phase: N/A
Study type: Observational

Research has shown that questionnaires completed on the internet have the potential to provide more complete and honest data with fewer errors in a more efficient manner than questionnaires completed using the paper and pencil format. Despite the numerous advantages of internet-administered questionnaires, it is important to make sure that the internet questionnaires will yield comparable results to the well-established paper and pencil versions. No one has studied internet administration of scoliosis specific questionnaires in adolescents with scoliosis. The investigators will test whether the internet administration of scoliosis questionnaires is as reliable as the traditional paper and pencil version. The investigators predict that the internet-administered questionnaire will provide the same reliability as the paper-administered questionnaires.

NCT ID: NCT01760434 Completed - Clinical trials for Adolescent Idiopathic Scoliosis

Long-Term Outcome Following the Treatment of Pediatric Scoliosis

Start date: January 2013
Phase: N/A
Study type: Interventional

Evaluate the long-term outcomes following operative and nonoperative treatment of childhood scoliosis.

NCT ID: NCT01663909 Completed - Pain Clinical Trials

Pain Management Using Guided Imagery for Adolescents Post-spinal Fusion

Start date: May 2010
Phase: N/A
Study type: Interventional

Surgery to correct scoliosis (spinal fusion)generates a severe pain intensity rending pain management a complex task. Several studies have found out that pharmacological interventions alone were not enough to provide optimal pain management for these patients. The investigators developed a DVD on guided imagery, customized for teenagers, to help them cope better with their pain. The investigators believe that this type of intervention combined with their usual analgesic medication will help them to control their pain and foster rehabilitation.