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NCT ID: NCT04877236 Withdrawn - Clinical trials for Adolescent Idiopathic Scoliosis

Green Sun Medical Dynamic Brace

Start date: November 21, 2019
Phase: N/A
Study type: Interventional

The Green Sun Medical Dynamic Brace (GSM) brace was developed as an alternative to rigid thoracolumbosacral orthoses (TLSOs, braces) commonly used to prevent continued curve progression in patients with adolescent idiopathic scoliosis (AIS). The brace applies corrective forces to the muscular and bony structures of the spine while preserving range of motion (ROM). The innovative design of this brace should provide an equivalent degree of correction of the scoliotic curvature as a rigid TLSO, with increased acceptability to the patient via improved comfort and spinal/chest wall mobility. Increased acceptability promotes increased adherence to treatment. This is a pilot study to collect preliminary short-term data concerning the safety and performance of the GSM brace in a sample of subjects with AIS who are currently being treated with a TLSO. The study will use clinical exams, x-rays, monitoring equipment, and questionnaires to primarily assess safety and performance. Secondary endpoints include spinal ROM and lung vital capacity assessment, as well as data validation. The study involves 3 visits, a performance check phone call, and 4 follow up calls over a four month span. This is a pilot study and no formal hypothesis testing will be done. Descriptive statistics of selected variables will be calculated.

NCT ID: NCT04684927 Withdrawn - Clinical trials for Adolescent Idiopathic Scoliosis

PMS Evaluation of Safety and Efficacy of the MID-C System 5 Years Post-implantation in AIS

Start date: January 20, 2021
Phase: N/A
Study type: Interventional

The ApiFix MID-C System is a unidirectional expandable rod, designed to be connected unilaterally to the spine via 2 anchor points on the concave side of a scoliotic deformity above and below the apex of the major curvature to treat adolescent idiopathic scoliosis. The MID-C System is designed to act as an internal brace. A total of 10 patients, who are planned to undrego the MID-C System implantation procedure will be enrolled for the study. A 5 years follow-up post surgery will be performed for these patients in order to evaluate the long term safety and efficacy of the MID-C System.

NCT ID: NCT04633031 Withdrawn - Clinical trials for Idiopathic Scoliosis

The Effect of Bracing on Sagittal Balance in Scoliosis

Start date: October 2012
Phase:
Study type: Observational

The goal of the study is to analyze the influence of bracing on sagittal balance in scoliosis. In special we want to observe if there is a difference between two types of TLSO-brace, namely boston and cheneau. Retrospective analyses of Full Spine X-rays of patients who underwent bracing-therapy in the context of scoliosis. Different spinopelvic parameters will be analyzed: pelvic incidence, pelvic tilt, sacral slope, lumbar lordosis, spinopelvic angle, spinosacral angle, thoracal kyphosis. Four different X-rays will be reviewed for these parameters: 1. Profile before bracing therapy 2. Profile after initiation of bracing therapy 3. Profile immediately after termination of bracing therapy 4. Profile more than 3 months after termination of brace It concerns patients with idiopathic scoliosis (exclusion of congenital scoliosis, neuromuscular scoliosis and associated spondylolisthesis). Goal of the study is to check if treatment with TLSO-brace has a delordosing effect on sagittal balance (decrease of lumbar lordosis). The zero-hypothesis: TLSO causes no decrease in lumbar lordosis. Secondary goal is to compare the effect of the BOSTON TSLO-brace and otherwise the CHENEAU TLSO-brace on spinopelvic parameters and lumbar lordosis in special.

NCT ID: NCT04461964 Withdrawn - Scoliosis Clinical Trials

Effects of a Spine Navigation System on Op-time and Radiation Exposure

Start date: July 2022
Phase: N/A
Study type: Interventional

The goal of this study is to prospectively collect information about the operative time and intraoperative radiation experienced by patients undergoing posterior spinal fusion procedures guided by the MvIGS spine navigation system.

NCT ID: NCT04003233 Withdrawn - Clinical trials for Idiopathic Scoliosis

Limited-efficacy Testing of Spring Distraction System (SDS) and Unilateral One-way Rod (MID-C) for Early Onset Scoliosis

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

The primary aim of this study is to investigate the limited efficacy of these innovative surgical solutions in treatment of Early Onset Scoliosis (EOS) in terms of maintaining reduction while maintaining spinal growth. The secondary aim is to compare both devices for these and other parameters as well as safety.

NCT ID: NCT03867240 Withdrawn - Pain, Postoperative Clinical Trials

Gabapentin and Chronic Post Surgical Pain

CPSP
Start date: June 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to investigate the effect of a common pain medication (gabapentin) on chronic postsurgical pain in pediatric patients who require surgery for idiopathic scoliosis.

NCT ID: NCT03843476 Withdrawn - Clinical trials for Degenerative Disc Disease

Personalized Spine Study Group Registry

Start date: January 2014
Phase:
Study type: Observational [Patient Registry]

As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. The secondary objective is to collect clinical and radiographic outcomes of patients with Medicrea hardware as a control cohort to the patient-specific rods.

NCT ID: NCT03609138 Withdrawn - Clinical trials for Scoliosis; Adolescence

O-arm Assessment of Vertebral Movement Using ST2R Technique

Start date: July 2018
Phase:
Study type: Observational

The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.

NCT ID: NCT03413839 Withdrawn - Clinical trials for Degenerative Scoliosis

Physiotherapeutic Scoliosis Specific Exercises As Treatment for Adult Degenerative Scoliosis

Start date: May 2020
Phase: N/A
Study type: Interventional

This is a pilot study to lead to a larger prospective, randomized, controlled study of older adult (ages 50 and older) spinal patients with thoracolumbar/lumbar scoliosis evaluating improvement with physiotherapeutic scoliosis-specific exercise (PSSE) compared to traditional low back physical therapy (PT).

NCT ID: NCT02590380 Withdrawn - Clinical trials for Adolescent Idiopathic Scoliosis

Comparing Pedicle Screw Systems for the Treatment of Adolescent Paediatric Spine Deformity

Start date: September 2022
Phase: N/A
Study type: Interventional

Evaluation of the efficacy of the K2M MESA Railâ„¢ Deformity System at improving coronal and sagittal correction of the adolescent idiopathic spine deformity in comparison to the side loading DePuy Synthes USS II pedicle screw system.