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Scoliosis clinical trials

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NCT ID: NCT03017755 Recruiting - Clinical trials for Scoliosis; Adolescence

Scoliosis Survey to Development Treatment Decision Tool

Start date: April 11, 2017
Phase:
Study type: Observational

This is a survey to help understand the influences related to the decision for Adolescent Idiopathic Scoliosis treatment (observation vs. bracing vs. surgery). The investigator then plans to create a decision aid to help families when making a decision about the treatment choice being presented to them.

NCT ID: NCT02968043 Recruiting - Clinical trials for Scoliosis Idiopathic Adolescent

Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis

Start date: February 13, 2017
Phase: N/A
Study type: Interventional

Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients. There are increasing evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai. Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study. Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.

NCT ID: NCT02862392 Recruiting - Scoliosis Clinical Trials

Predictive Progressive Factors of Adolescent Idiopathic Scoliosis

SCOLEVOL
Start date: March 15, 2017
Phase:
Study type: Observational

The hypothesis of this study is that progressive AIS is characterized by a disorder of orthostatic postural control. The analysis and the treatment of posturographic signal on computerized integrate force plates, coupled to clinical and radiographic examinations, could highlight predictive and reliable factors at the moment of diagnosis. Thus, it could help the clinician in his therapeutic approach, based on the postural control improvement (individualized prescription in kinesitherapy, better adaptation to orthopedic treatments by corset). This method is non-invasive, without side effects, fast and achievable in routine care at the moment of the diagnosis of AIS.

NCT ID: NCT02819245 Recruiting - Scoliosis Clinical Trials

Impact of Age on Surgical Outcome of Adolescent Idiopathic Scoliosis

Start date: January 2003
Phase: N/A
Study type: Interventional

This is a study prospectively enrolling adolescent idiopathic scoliosis (AIS) patients and try to find how the age will impact the surgical outcome of AIS.

NCT ID: NCT02771899 Recruiting - Scoliosis Clinical Trials

Value of 3D Modeling in Spine Surgery

Start date: April 2016
Phase: N/A
Study type: Interventional

Adults (18 years and over) and children (10-17 years of age) scheduled for surgery to correct scoliosis will be included in this study, for which participation will last 6 months. Each age group of participants will be randomized to two cohorts: one cohort will receive standard of care, while the other will also have their standard radiographic images used in the construction of a three-dimensional visualization of the spine. Questionnaires administered before and after surgery, in addition to health information collected throughout the course of the study, will indicate whether the three-dimensional model has an effect on the planning, performance, and outcomes of surgery. Participants in this study will not be asked to do anything outside the standard of care. The only manipulated variable in this study is the construction of the three dimensional model, which is made from information collected during the standard of care, and requires no further action on the participant's behalf. The results of this study may show that three-dimensional visualizations can be of value to spinal surgeons, and positively affect patient outcomes.

NCT ID: NCT02659722 Recruiting - Back Pain Clinical Trials

InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)

Start date: January 2014
Phase: N/A
Study type: Observational

The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients undergoing long construct fusion for degenerative disc disease and/or scoliosis. Comparisons will be made with published historical data..

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: NCT02315729 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Analysis of Prognostic Cell Signaling Factors in Adolescent Idiopathic Scoliosis

Start date: November 2016
Phase:
Study type: Observational

The purpose of this study is to identify potential markers for curve progression in adolescent idiopathic scoliosis (AIS). Despite its prevalence and impact on child health, the etiology of AIS and molecular mechanisms underlying its development and progression remain poorly understood. Clinical criteria and features cannot adequately predict which children, diagnosed with mild disease, will undergo subsequent curve progression requiring intervention. The investigators hypothesize that alterations in specific genetic markers will be correlated with the progression of AIS curves over time. Thus, these markers could be used in the future to develop a reliable, inexpensive and relatively non-invasive cell based diagnostic test to (1) predict spinal curve progression in AIS, (2) select patients likely to benefit from early surgical intervention, and (3) potentially screen for asymptomatic children at risk of developing idiopathic scoliosis.

NCT ID: NCT02227537 Recruiting - Clinical trials for Adolescence Idiopathic Scoliosis

Evaluation of the Providence Nighttime Brace for the Treatment of Adolescence Idiopathic Scoliosis

Start date: October 2014
Phase: N/A
Study type: Observational

A multicenter, prospective, non-randomized, single-arm observational study evaluating the Providence nighttime bracing system in patients diagnosed with adolescence idiopathic scoliosis.

NCT ID: NCT01135940 Recruiting - Wounds Clinical Trials

The Use of Dermabond Versus Standard Staple for Wound Closure in Children With Neuromuscular Scoliosis Undergoing Spinal Deformity Correction Surgery

Start date: May 2010
Phase: Phase 2
Study type: Interventional

This is a prospective, Phase II (hypothesis generating) randomized pilot study investigating the efficacy of using Dermabond as a method of final wound closure as compared to the standard staple method in children with Neuromuscular Scoliosis undergoing spinal deformity correction surgery.