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Scoliosis clinical trials

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NCT ID: NCT04746586 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Identification of Circulating microRNAs in Adolescent Idiopathic Scoliosis

IMIRSA
Start date: July 22, 2020
Phase:
Study type: Observational

The aim of the present study is to evaluate the expression of a large panel of microRNAs, already known and validated in other ortopedic pathologies and bone metabolism, in the plasma of Adolescent Idiopathic Scoliosis (AIS) patients. The deregulated microRNAs identified will be then validated and computational analyzes will determine their potential involvement in the metabolism of bone and/or cartilage tissue in order to correlate the results obtained with the clinical data of the AIS patients. The investigators aimed to develop a microRNAs panel to further validate in a larger population of AIS patients in order to produce a device for the diagnosis and prognosis of Molecular-based AIS.

NCT ID: NCT04746417 Recruiting - Clinical trials for Idiopathic Scoliosis

Assessment of Skeletal Maturity Using Proximal Femoral Epiphysis in Patients With Scoliosis

Start date: February 1, 2021
Phase:
Study type: Observational

This study aims to explore the use of proximal femoral head for the assessment of skeletal maturity in patients with idiopathic scoliosis. The aim is to validate the use of the stages of proximal femoral epiphyseal closure in assessing pubertal growth landmarks in this patient cohort. The grading system of this skeletal maturity index will be established and its reliability and reproducibility in clinical use will be examined.

NCT ID: NCT04697498 Recruiting - Chronic Pain Clinical Trials

Bilateral Bi-level Erector Spine Plane Block as a Component of General Anesthesia in Surgical Correction of Spinal Deformations

BBESPB
Start date: December 16, 2020
Phase: N/A
Study type: Interventional

Improving the anesthesiology management for surgical correction of spinal deformations with introducing the diagnostic methods and treatment strategy of acute pain, preventing the evolution of chronic pain. Development and implementation in clinical practice perioperative intensive care protocols for surgical correction of spinal deformities.

NCT ID: NCT04637802 Recruiting - Spondylolisthesis Clinical Trials

Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery

SurgeryPal
Start date: December 29, 2020
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery. Youth will be randomized on an individual level using a factorial design to SurgeryPal or Education during 2 phases of intervention: 1) pre-operative phase (4 week duration delivered over the 4 weeks leading up to surgery), and 2) post-operative phase (4 week duration following surgery). Thus there will be 4 treatment arms. Participants will undergo 4 assessments, independent of their treatment assignment: T1: Baseline (pre-randomization); T2: acute post-surgery outcomes (daily assessment of acute outcomes beginning day 1 through day 14 after hospital discharge from surgery); T3: Post-surgery follow-up (assessment of outcomes at 3-months post-surgery); T4: Final post-surgery follow-up (assessment of outcomes at 6-months post-surgery).

NCT ID: NCT04611490 Recruiting - Safety Issues Clinical Trials

Preoperative and Peroperative Comparison Between 3D Spine Reconstructions

Spine-PDCA-OR
Start date: July 30, 2020
Phase:
Study type: Observational

The objective is to collect data from a per-operative navigation system called SURGIVISIO during scoliosis surgeries. A research program is in progress in order super-impose pre-operative 3D reconstructions of the spine performed with the EOS system on the per-operative 3D reconstructions performed with the SURGIVISIO system. The purpose of the study is to collect the pre and per operatives data in order to perform the research and development program.

NCT ID: NCT04601363 Recruiting - Clinical trials for Degenerative Disc Disease

Personalized Spine Study Group (PSSG) Registry

PSSG
Start date: October 29, 2020
Phase:
Study type: Observational

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

NCT ID: NCT04568759 Recruiting - Clinical trials for Adolescent Idiopathic Scoliosis

Effect of a Postural Re-education Intervention Compared to Standard Care on Scoliosis Progression in Adolescent

RCT-RPG
Start date: August 15, 2021
Phase: N/A
Study type: Interventional

The aim of this project is to verify the effect of the global postural reeducation (GPR) intervention used in physiotherapy on scoliosis progression (scoliosis angle), back pain, quality of life, respiratory function, trunk posture and trunk muscle functioning and walking endurance. To do so, we will recruit 144 participants at three scoliosis specialized Centers. Participants will be randomly allocated to the standard of care (SC) group (observation or brace plus home video of exercises for 12 months) or to the GPR group (SC plus individual sessions once a week for 6 months and individual sessions alternating with telerehabilitation sessions once per two weeks between 6 and 12 months). At initial, 6, 12- and 24-months evaluation, participants will have x-ray, complete self-report questionnaires to document back pain and quality of life. Thereafter, measurement of trunk posture, electromyography activity of the back muscles, excursion of the diaphragm muscle using echography and respiratory function as well as distance covered using the 6-minute walk test for walking endurance will be done. We believe that GPR intervention may prevent scoliosis progression and improve physical health and quality of life in adolescence.

NCT ID: NCT04566874 Recruiting - Clinical trials for Degenerative Disc Disease

SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2

Start date: July 13, 2020
Phase: N/A
Study type: Interventional

A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP

NCT ID: NCT04539522 Recruiting - Clinical trials for Idiopathic Scoliosis

Efficacy of a Three-dimensionally Corrective Exercise Therapy for Scoliosis

Start date: October 30, 2020
Phase: N/A
Study type: Interventional

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 corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focuses on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional self-correction, balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient. Nevertheless, the evidence concerning three-dimensionally corrective exercise for scoliosis is inadequate. Therefore, the objective of this study is to determine the effect of three-dimensionally corrective exercise intervention on the change of Cobb angle, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life, compared to conventional exercise therapy for patients with mild and moderate AIS. Informed consent will be obtained from each patient and one of their parents prior to inclusion. Eligible subjects will be divided into two groups(experimental group or control group) according to their wishes. Subjects in experimental group will perform three-dimensionally corrective exercise for scoliosis (moderate patients combined with a brace) and those in the control group will receive conventional exercise therapy (moderate patients combined with a brace). Blinded assessments at baseline and immediately post 12-month intervention will include radiographic measurement, trunk rotation, sagittal profile, lung function, exercise endurance and health related quality-of-life.

NCT ID: NCT04509310 Recruiting - Scoliosis Clinical Trials

Active Bodysuits for Adult Degenerative Scoliosis

Start date: January 6, 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.