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Scoliosis clinical trials

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NCT ID: NCT03135665 Completed - Scoliosis Clinical Trials

Using Radiation-free Ultrasound for Screening Scoliosis Among School Children in Hong Kong to Reduce Unnecessary X-ray Exposure

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

In the scoliosis screening program of the Student Health Service (SHS), Department of Health (DH), in Hong Kong, more than 50% of screened school children prescribed with x-ray examination basing on the screening protocol did not have Cobb angle greater than the referral threshold of 20°; ie they did not need specialist referral and thus were subjected to unnecessary x-ray exposure. Our primary objective is to determine whether a new radiation-free ultrasound system could identify subjects with Cobb angle greater than the referral threshold of 20° thus avoiding unnecessary x-rays in the referral workflow. The secondary objective is to evaluate if Angle of Trunk Rotation (ATR) can further increase the accuracy of ultrasound assessment.

NCT ID: NCT03110965 Completed - Scoliosis Clinical Trials

Yoga in the Treatment of Adolescent Idiopathic and Degenerative Scoliosis

Start date: January 1, 2015
Phase: N/A
Study type: Interventional

The effect of two isometric exercises is measured on Cobb angles from films taken 4-10 months apart.

NCT ID: NCT03071471 Completed - Clinical trials for Adolescent Idiopathic Scoliosis (AIS)

Feasibility Evaluation Study of the MID-C Device

MID-C
Start date: June 2014
Phase: N/A
Study type: Observational [Patient Registry]

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.

NCT ID: NCT03071445 Completed - Clinical trials for Adolescent Idiopathic Scoliosis (AIS)

Feasibility Study of MID-C for AIS

MID-C
Start date: April 2012
Phase: N/A
Study type: Observational [Patient Registry]

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.

NCT ID: NCT03000010 Completed - Clinical trials for Neuromuscular Scoliosis

Wound Vac Bandage Comparison After Spinal Fusion

WV
Start date: July 16, 2012
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the effectiveness of incisional vacuum-assisted closure (VAC) therapy in the prevention of infection after posterior spinal fusion for pediatric neuromuscular scoliosis, in comparison to a regular gauze bandage.

NCT ID: NCT02996643 Completed - Clinical trials for Scoliosis; Adolescence

Ultrasound-Assisted Brace Casting for AIS

Start date: January 2012
Phase: Phase 0
Study type: Interventional

Adolescent Idiopathic Scoliosis (AIS) is a three-dimensional deformity of the spine associated with vertebral rotation. Brace treatment is the most commonly used non-surgical treatment. To obtain the best possible outcome, the best in-brace correction within the patient's accepted tolerance must be provided. However, in the existing clinical practice, the immediate in-brace correction cannot be measured during the design and fitting of the brace because the correction is determined using a radiograph. This study is to evaluate the effect of applying ultrasound to measure the stimulated in-brace correction during brace casting.

NCT ID: NCT02995525 Completed - Chronic Pain Clinical Trials

Chronic Pain After Scoliosis and Thoracic Surgery in Children

PEDIACHROII
Start date: December 2016
Phase:
Study type: Observational

The aim of this epidemiologic prospective study is to determine the prevalence of CPSP defined as pain occurring 4 months after scoliosis and thoracic surgery and rated > 3 on a 10 point visual analogue scale or FLACC scale, in children aged from 6 to 18 years. The main objective : prevalence of chronic post surgical pain 4 months after scoliosis ant thoracic surgery in children aged 6 to 18 years. The secondary objectives: the intensity of chronic post surgical pain, the prevalence of neuropathic syndrome and the predictive risk factors.

NCT ID: NCT02994030 Completed - Clinical trials for Duchenne Muscular Dystrophy

Biomarker for Duchenne Muscular Dystrophy

BioDuchenne
Start date: August 20, 2018
Phase:
Study type: Observational

International, multicenter, observational, longitudinal study to identify biomarker/s for Duchenne Muscular Dystropy (DMD) and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s.

NCT ID: NCT02978820 Completed - Scoliosis Clinical Trials

The Comparison of Core Stabilization Exercise With Scientific Exercise Approach to Scoliosis in Idiopathic Scoliosis

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

Scoliosis specific exercises have been shown to improve curve progression but there have been few studies that compare the different exercise approaches in adolescent idiopathic scoliosis (AIS). The objective of this study was to compare the effects of Core stabilization (CS) exercises with Scientific Exercises Approach to Scoliosis (SEAS exercises) in addition to brace wearing in patients with AIS. It is important to compare different exercise methods on different aspects of scoliotic deformity, such as curve progression, angle of trunk rotation, body symmetry, cosmetic trunk deformity, satisfaction with treatment and quality of life.

NCT ID: NCT02904421 Completed - Scoliosis Clinical Trials

6 Years Study on Changes in Bone Quality, Bone Turnover and Curve Severity in AIS With and Without Calcium and Vit-D Supplementation

Start date: October 2016
Phase:
Study type: Observational

The study aimed to: 1. To investigate and compare the changes in bone mineral density (BMD), trabecular bone micro-architecture, bone strength, and curve severity at a mean of 6 years longitudinal follow up in AIS girls with low bone mass between Group A and B: 1. Group A: subjects followed at a mean of 4 years after completion of 2-year calcium and Vit-D supplementation and 2. Group B: subjects without calcium and Vit-D supplementation 2. To evaluate the correlation between changes in BMD, trabecular bone micro-architecture, and bone strength documented in Objective 1 with changes in serum bone turnover markers