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Scoliosis clinical trials

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NCT ID: NCT06301984 Not yet recruiting - Clinical trials for Early Onset Scoliosis (EOS)

Safety and Efficacy Evaluation of Insight GS Growing System

Start date: July 2024
Phase: Phase 3
Study type: Interventional

Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth. The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE). Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study. Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events.

NCT ID: NCT06298812 Not yet recruiting - Clinical trials for Idiopathic Scoliosis

REFLECT Scoliosis System Post Approval Study

Start date: March 31, 2024
Phase: N/A
Study type: Interventional

The purpose of this multi-center, prospective, single-arm registry Post-Approval Study (PAS) is to evaluate the radiographic and clinical outcomes of 100 patients with idiopathic scoliosis treated with the REFLECTâ„¢ Scoliosis Correction System, as a condition of HDE approval

NCT ID: NCT06295991 Not yet recruiting - Clinical trials for Respiratory Function Test

The Effect of Lycra Garments on Spastic Diplegic Cerebral Palsy Patients With Scoliosis

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

The primary aim of this study was to investigate the effects of lycra clothing on balance and respiratory functions in individuals with cerebral palsy with scoliosis, and the secondary aim was to investigate the effects of lycra clothing on motor function, activity limitation and quality of life in these individuals.

NCT ID: NCT06290843 Not yet recruiting - Clinical trials for Idiopathic Scoliosis

Analysis of Body Balance Parameters in Children With Idiopathic Scoliosis

Start date: April 5, 2024
Phase:
Study type: Observational

The aim of the study is to compare body balance parameters assessed using the AMTI dynamometric platform in children with idiopathic scoliosis (with and without Schroth therapy) compared to control group.

NCT ID: NCT06279468 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Clinical Effectiveness of Intervertebral Disc Release in Treating Lenke 5 Adolescent Idiopathic Scoliosis

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Adolescent idiopathic scoliosis (AIS) poses challenges in achieving optimal three-dimensional correction. While posterior fusion with pedicle screws has shown success, osteotomy techniques, such as Ponte osteotomy, have further improved outcomes. However, residual vertebral rotation remains a concern, impacting long-term complications. Intervertebral disc release (IDR) presents a potential solution to enhance derotation and reduce fusion levels, particularly in Lenke Type 5 AIS. This prospective randomized controlled trial aims to evaluate the clinical effectiveness of IDR in treating Lenke 5 AIS, comparing it to Ponte osteotomy. The study focuses on axial vertebral rotation correction, coronal curve improvement, blood loss, hospital stay, and adverse events. Participants aged 10-18 with Lenke 5 AIS will undergo either IDR or Ponte osteotomy, randomly assigned. Outcome measures include axial rotation correction rate, radiographic parameters, and clinical assessments. A total of 132 participants will be recruited. The IDR technique, through posterior disc removal, presents a promising approach to optimize derotation in Lenke 5 AIS. While offering potential advantages, challenges like limited working space and bleeding risks require careful consideration. The study's findings aim to provide robust clinical evidence, enhancing treatment strategies for Lenke 5 AIS and offering innovative approaches for AIS as a whole.

NCT ID: NCT06277089 Not yet recruiting - Scoliosis Clinical Trials

Curve Correction of Early Onset Scoliosis by Mehta Serial Casts

Start date: March 1, 2024
Phase: N/A
Study type: Interventional

Assessment of the role of Mehta Serial Casts in Curve Correction of Early Onset Scoliosis

NCT ID: NCT06276972 Active, not recruiting - Scoliosis Clinical Trials

Relationship Between Spine Coronal Alignment and Lower Limb Biomechanical in Scoliosis

Start date: March 12, 2023
Phase:
Study type: Observational

To examine the relationships between spine coronal alignment and lower limb biomechanical parameters in scoliotic adolescents

NCT ID: NCT06266637 Active, not recruiting - Clinical trials for Scoliosis Idiopathic

Effect of Scoliosis-Specific Exercise on Lower Limb Biomechanics

Start date: March 12, 2023
Phase: N/A
Study type: Interventional

PURPOSE: To examine the effect of Physiotherapeutic Scoliosis-Specific Exercise on limb biomechanical parameters in adolescents with idiopathic scoliosis. A randomised controlled trial BACKGROUND: Adolescent idiopathic scoliosis is one of the most common orthopaedic diseases affecting the spine during adolescence. The efficacy of exercise treatment is controversial. Although evidence suggests that PSSE, which include auto-correction in 3D, integration in daily life, stabilizing the corrected posture, and patient education, could improve some outcomes, effect of PSSE on related biomechanical alterations in lower limbs have not yet been examined. HYPOTHESES: Null hypothesis There are no statistically significant effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents. RESEARCH QUESTION: What are the effect of Physiotherapeutic Scoliosis-Specific Exercise on lower limb biomechanics in scoliotic adolescents.?

NCT ID: NCT06262269 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Interest of Adapted Physical Activity by Tele-rehabilitation in Chronic Pathology - Idiopathic Scoliosis in Adolescents

Start date: September 21, 2022
Phase: N/A
Study type: Interventional

This study is a randomised controlled trial designed to compare two adapted physical activity treatments for adolescent idiopathic scoliosis (AIS). The main hypotheses it aims to address are as follows: - Treatment with a HIIT (High-Intensity Interval Training) type training program via tele-rehabilitation, supervised by an adapted physical activity teacher, is effective in AIS. - A 12-week physical activity program maintains this efficacy over the long term. To test this hypothesis, Two groups of adolescents will be evaluated: a first group made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a tele-rehabilitation (physical activity sessions at home supervised by a teacher in adapted physical activities by video). A second group, control, also made up of non-athletic adolescents suffering from Idiopathic Scoliosis who will benefit from a self-program at home consisting of exercises specific to their scoliosis.

NCT ID: NCT06258161 Not yet recruiting - Scoliosis Clinical Trials

Effect of Adult Spinal Deformity Surgery on Functional Reach

Start date: March 2024
Phase:
Study type: Observational

Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing. However, current tests do not provide insight into the limits of balance during normal ADL. The goal of this research is to develop a new balance assessment that includes a functional reach test (FRT) to provide numerical data on the limits of one's ability to maintain balance. The study will include both ASD patients and matched healthy adults and will compare postural sway measures between them. Wearable motion tracking sensors and a force plate will be used to monitor body movement and changes in the center of pressure under foot during normal standing and during a FRT. Data from this study will inform spine surgeons of ASD patient's risk of balance loss in daily life and enable further research on the effects of surgical techniques to restore balance among ASD surgery patients.