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Scoliosis clinical trials

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NCT ID: NCT03533010 Recruiting - Scoliosis Clinical Trials

Preventing Curve Progression and the Need for Bracing in Adolescent Idiopathic Scoliosis With Calcium + Vitamin D Supplementation

Start date: July 1, 2018
Phase: N/A
Study type: Interventional

There is an association between adolescent idiopathic scoliosis (AIS) and low bone mass which has been reported to be a significant prognostic factor for curve progression. Given that dietary calcium (Ca) intake and serum Vit-D levels were also low in AIS, we therefore propose a randomized double-blinded placebo-controlled trial to evaluate if daily [500mg Ca + 800 IU Vit-D] can improve bone health and prevent curve progression in AIS. Immature AIS girls with Cobb angle 10-20 degrees will be randomized either to the Treatment or Placebo group with 3-year of treatment. The main outcome measures for evaluation for those who have completed the 3-year treatment and have reached skeletal maturity at the end of 3-year treatment include: (1) percentage of patients with increase in Cobb angleā‰„6 degrees and (2) percentage of patients who require bracing. Bone measurements using advanced image acquisition technology(HR-pQCT) to assess bone health will also be evaluated.

NCT ID: NCT03519321 Recruiting - Scoliosis Clinical Trials

Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis

Start date: April 11, 2018
Phase: N/A
Study type: Interventional

Early Onset Scoliosis (EOS) is defined as scoliosis with onset under the age of ten years, regardless of etiology. It is a complex three-dimensional deformity of the spine which can cause significant physical and psychological problems. Currently there are two basic treatment options available for EOS: non-surgical and surgical. ApiFix Ltd. has developed a novel growing rod system for surgical treatment of EOS, the MID-C system. It is indicated for patients with a scoliosis of 35 to 75 degrees Cobb angle

NCT ID: NCT03427970 Recruiting - Clinical trials for Scoliosis,Idiopathic,Adolescent

Efficacy of Three-dimensionally Integrated Exercise for Scoliosis in Patients With Adolescent Idiopathic Scoliosis

Start date: June 25, 2018
Phase: N/A
Study type: Interventional

Adolescent idiopathic scoliosis (AIS) is one of the most prevalent spinal deformity that may progress sharply during growth. It is recommended that the physiotherapeutic scoliosis-specific exercises should be the first step to treat idiopathic scoliosis to prevent/limit progression of the deformity. Three-dimensionally integrated exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, and consists of patient education, 3-dimension self-correction, stabilization of the corrected posture and training activity of daily living, combined with neuro-motor control, proprioceptive training, balance training, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally integrated exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally integrated exercise intervention on the change of Cobb angle, angle of trunk rotation(ATR), sagittal profile, and quality of life, compared to standard care for patients with mild AIS. Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the experimental group, in which they will perform three-dimensionally integrated exercise for scoliosis, or the control group, in which they will receive the standard of care with observation according to the Scoliosis Research Society criteria.Blinded assessments at baseline and immediately post 6-month intervention will include radiographic measurement, trunk rotation, sagittal profile and health related quality-of-life.

NCT ID: NCT03418987 Recruiting - Scoliosis Clinical Trials

The Vertebral Vector in a Horizontal Plane. A Simple Way to See in 3D.

Start date: March 20, 2018
Phase:
Study type: Observational

The diagnosis and classification of scoliosis are almost exclusively based on frontal and lateral radiographs. Current classifications of adolescent or adult idiopathic degenerative scoliosis are based only on the 2D approach. The classifications consider only the lateral deviation and the sagittal alignment and completely ignore all the changes (the axial vertebral rotation and the lateral translation etc ...) in the horizontal plane. The demand for an accurate assessment of the vertebral rotation in scoliosis is not new. Biplane x-ray images provide insufficient quantitative or qualitative information on the anatomical landmarks needed to determine axial rotation. Several measurement methods have been published, all of which are based on the evaluation of the relative positions of various posterior vertebral elements. The Perdriolle torsiometer is currently the most accepted method in clinical practice, but its reproducibility is very limited and can not be quantified accurately.The horizontal plane deviations are more accurately evaluated by the CT scan, but the systematic use of this method is limited because of its relatively high cost and excessive radiation dose. Expert opinion is also divided on the veracity and reproducibility of CT scan for such measurements. Given the absence of a definitive and reproducible measurement method for 3D characterization of the vertebral columnar deformities, the investigators introduced the concept and system of vertebral vectors.The vertebral vector technique is currently the only technique in the world that allows the visualization of vertebral column deformities by analyzing each vertebral body and defining characteristic mathematical and geometric parameters that uniquely characterize each vertebrae. A new digital radioimaging technique based on a low dose X-ray detection technology simultaneously creates frontal and lateral whole body radiographic images captured in a standing position, which is the basis of visualization of the vertebral vector. To examine the two phenotypes of scoliosis, it is necessary to collect the radiological data specific to the disease. After generating the vertebral vectors and obtaining the three-dimensional coordinates, an analysis and an exact mathematical description will be performed. The projections of the curves in the three planes will also be analyzed, with particular attention to the projections in the horizontal planes. Based on the mathematical models and the axial projection of the curves, a new three-dimensional classification can be imagined for the first time not only for adolescent scoliosis, but also for adult degenerative scoliosis. The main objective of this study is to develop new evidence-based treatments based on the unambiguous understanding of 3D features of vertebral columnar deformities.

NCT ID: NCT03332277 Recruiting - Scoliosis Clinical Trials

Active Bodysuits for Adult Degenerative Scoliosis

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

Adult degenerative (de novo) scoliosis (ADS) is a condition of the ageing population caused by degenerative changes without pre-existing spinal deformity. Pain is the most frequent problem, especially low back pain and radicular pain, and seriously affects the daily activities and health of ADS patients. The current treatment for ADS is not well defined. The main intervention for ADS treatment is surgical, but surgery is clearly not appropriate for every patient. Active bodysuits will be designed based on body alignment and pain management using special design components and incorporating active posture training from a biofeedback system. Back pain is often localized along the convexity of the curve, and passive support to the areas of pain, most likely in the lower trunk, hip and lower extremities, should be provided.

NCT ID: NCT03331094 Recruiting - Scoliosis Clinical Trials

Adult Scoliosis Correction by Bipolar Mini-invasive Assembly Without Graft

Start date: December 6, 2016
Phase:
Study type: Observational

The objective of the study will be to estimate the correction obtained with a metallic instrumentation, by mini-invasive technique with bipolar assembly and ilio-sacred EUROS ®) screw , without transplant at the adult as compared to that obtained with the surgery with complete exhibition of the rachis and bone graft.

NCT ID: NCT03292601 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Brace Monitoring for Adolescent Idiopathic Scoliosis (AIS)

Start date: October 18, 2017
Phase: N/A
Study type: Interventional

The overall aim of the study is to utilize a novel device and smartphone application in order to improve measurement of patient compliance with at-home bracing for scoliosis as well as create a more accurate assessment of brace fit via continuous and objective measures of tension. These ground-breaking metrics will provide analyzable data to more accurately reflect and predict actual patient compliance as well as allow for further exploration of how to increase compliance, and thus, efficacy of bracing; it will additionally allow both physicians and patients to have a more reliable measure for brace fit by providing them with continuous data of fit via tension, and provide built-in feedback mechanisms to the patient to ensure proper tightness of the brace. Additionally, the study will investigate whether providing the wearer's own brace-wear compliance information directly to the patient and their caregiver(s) via the mobile app will further improve rates of compliance as compared to those who do not receive the same feedback mechanism.

NCT ID: NCT03222739 Recruiting - Clinical trials for Scoliosis Idiopathic

Ultrasound for Scoliosis Diagnostic Evaluation

Start date: March 14, 2018
Phase: N/A
Study type: Interventional

Scoliosis is a complex 3-dimensional deformity of the spine. It may occur at any time throughout growth and development and is typically detected through x-ray imaging. Although effective at visualizing a curve, x-ray imaging is costly and may expose children to potentially harmful ionizing radiation. This is a 30 patient study to evaluate the reliability of ultrasound, an imaging technique without radiation, to effectively measure scoliosis deformities compared to the gold-standard of x-ray.

NCT ID: NCT03107533 Recruiting - Scoliosis Clinical Trials

Scoliosis Shared Decision Making

Start date: March 30, 2017
Phase:
Study type: Observational

Analysis of video encounters between providers, patients, and families will be used to develop a shared decision making tool for patients deciding between surgery and observation for scoliosis treatment.

NCT ID: NCT03059420 Recruiting - Facial Palsy Clinical Trials

Genetic Studies of Strabismus, Congenital Cranial Dysinnervation Disorders (CCDDs), and Their Associated Anomalies

Start date: February 1, 2004
Phase:
Study type: Observational

The purpose of this study is to identify genes associated with impaired development and function of the cranial nerves and brainstem, which may result in misalignment of the eyes (strabismus) and related conditions.