Clinical trials: Scoliosis
Scoliosis Neuromuscular, Scoliosis Idiopathic
Post-market Clinical Follow-up Study of NEMOST V2
The NEMOST spinal implant is a growth domino intended for the surgical treatment of progressive scoliosis in children. As part of post-market surveillance, EUROS is conducting a retrospective and prospective study to collect…
- Conditions
- Scoliosis Neuromuscular, Scoliosis Idiopathic, Consent Forms
- Trial name
- NEMOST V2 (NCT07403084)
- Testing
- NEMOST V2 growing domino
- Where
- 5 sites in France
- Volunteers
- 140 people
- Sponsor
- EUROS
Scoliosis
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
It is current practice for children who have surgery for early onset scoliosis (EOS) to be treated with insertion of extendable implants known as growth rod systems.
- Trial name
- NCT01362881
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Ellipse Technologies, Inc.
Adolescent Idiopathic Scoliosis, Juvenile Idiopathic Scoliosis
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period
The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.
- Trial name
- FUTURE (NCT04992845)
- Testing
- Anterior Vertebral Body Tethering
- Where
- Canada
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Spino Modulation Inc.
Idiopathic Scoliosis
REFLECT Scoliosis System Post Approval Study
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 REFLECT™ Scoliosis…
- Trial name
- NCT06298812
- Testing
- REFLECT Scoliosis Correction System
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Globus Medical Inc
Scoliosis
Study of 3D Scanning for Adolescent Scoliosis
The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the…
- Trial name
- NCT06035952
- Testing
- 3D topographical scan
- Where
- 2 sites in United States
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- NSite Medical
Increased Lordosis/Scoliosis, Hyporeflexia
Biomarker for Duchenne Muscular Dystrophy
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.
- Conditions
- Increased Lordosis/Scoliosis, Hyporeflexia, Duchenne Muscular Dystrophy, Red-Green Color Blindness
- Trial name
- BioDuchenne (NCT02994030)
- Where
- 12 sites in Albania, Egypt and 6 more
- Volunteers
- 103 people
- Sponsor
- CENTOGENE GmbH Rostock
Idiopathic Scoliosis, Spinal Curvatures
UNiD Rods Register
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety
- Conditions
- Idiopathic Scoliosis, Spinal Curvatures, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT02926404
- Testing
- UNiD Rods
- Where
- 13 sites in Belgium, France and 1 more
- Volunteers
- 743 people
- Sponsor
- Medicrea International
Adolescent Idiopathic Scoliosis (AIS)
Evaluation of a Novel Semi-Rigid Brace for Adolescent Idiopathic Scoliosis
Introduction: Spinal bracing remains the gold standard for conservative management of adolescent idiopathic scoliosis (AIS). However, poor adherence often limits treatment efficacy.
- Trial name
- NCT07040150
- Testing
- Spinal bracing
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Nippon Sigmax co., ltd.
Adolescent Idiopathic Scoliosis
Green Sun Medical Dynamic Scoliosis Brace
This is a pilot study to collect preliminary short-term data concerning the safety and performance of the Green Sun Dynamic brace in a sample of subjects with adolescent idiopathic scoliosis who are currently being treated with a…
- Trial name
- GSM (NCT03641469)
- Testing
- Green Sun Dynamic Brace
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Green Sun medical
Psychological Stress, Cardiopulmonary Bypass Surgery
CARINAE for Stress Relief in Perioperative Care
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement
- Trial name
- CARINAE (NCT05184725)
- Testing
- SaMD CARINAE
- Where
- 5 sites in Italy, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Adhera Health, Inc.
Scoliosis Idiopathic
PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves.
- Trial name
- NCT05830825
- Testing
- Vertebral Body Tethering (VBT)
- Where
- 3 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- LDR Médical SAS
Scoliosis; Adolescence
O-arm Assessment of Vertebral Movement Using ST2R Technique
The study is quantifying how the patients' back has been corrected using Medicrea's hardware through imaging taken before,during and after the surgery.
- Trial name
- NCT03609138
- Testing
- Spinal Hardware
- Sponsor
- Medicrea, USA Corp.
Degenerative Disc Disease, Kyphosis
Post-Market Clinical Follow-up Study of A-SPINE's Products
This is a post-market clinical follow-up study that use questionnaires such as Visual Analog Scale (VAS), the Neck Disability Index (NDI), or the Oswestry Disability Index (ODI) to compare the clinical improvement effects before…
- Conditions
- Degenerative Disc Disease, Kyphosis, Scoliosis, Trauma
- Trial name
- NCT04848376
- Testing
- (1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L
- Where
- Taiwan
- Volunteers
- 200 people
- Sponsor
- A-Spine Asia Co., Ltd.
Scoliosis, Back Pain
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients…
- Trial name
- NCT02659722
- Testing
- InterFuse
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Vertebral Technologies, Inc.
Idiopathic Scoliosis
A Study to Evaluate a New Semi-rigid Brace, the RESILIENT Brace by Thinks Works, as a Way to Limit Curve Worsening in Kids With Idiopathic Scoliosis.
The goal of this clinical trial is to learn if the RESILIENT Scoliosis Brace System works to treat children with idiopathic scoliosis. It will also learn about the safety, comfort, and usability of the brace.
- Trial name
- RESILIENT (NCT07574632)
- Testing
- The RESILIENT scoliosis brace system
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Thinks Works, PBC
Idiopathic Scoliosis
A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis
This study reviews medical records of children and adolescents treated for idiopathic scoliosis (a sideways curve of the spine with no known cause) using the REFLECT™ Scoliosis Correction System.
- Trial name
- NCT07589023
- Testing
- Scoliosis Correction System
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 100 people
- Sponsor
- Globus Medical Inc
Spinal Muscular Atrophy, Spine Deformity
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).
- Conditions
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- Trial name
- PIERRE (NCT05866419)
- Testing
- ThecaFlex DRx System
- Where
- 21 sites in United States, Germany and 3 more
- Volunteers
- 90 people
- Sponsor
- Alcyone Therapeutics, Inc
Hyperkyphosis, Hyperlordosis
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Complex
Multicenter, multinational Post-Market Clinical Follow-Up (PMCF) study on the safety and performance of Ennovate® Complex - A prospective, pure data collection of all Ennovate® scoliosis patients in selected centers (not…
- Conditions
- Hyperkyphosis, Hyperlordosis, Congenital Scoliosis, Neuromuscular Scoliosis
- Trial name
- COSINE (NCT05281757)
- Testing
- posterior stabilization for the cervical spine
- Where
- 2 sites in Czechia, Malaysia
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Scoliosis, Scoliosis Idiopathic
Minimal Invasive Deformity Correction (MID-C) System for Early Onset Scoliosis
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…
- Conditions
- Scoliosis, Scoliosis Idiopathic, Scoliosis;Congenital
- Trial name
- NCT03519321
- Testing
- MID-C
- Where
- Greece
- Volunteers
- 60 people
- Sponsor
- Apifix
Juvenile Idiopathic Scoliosis, Adolescent Idiopathic Scoliosis
Study of the Braive Growth Modulation System for Progressive Pediatric Scoliosis
The purpose of this study was to establish probable benefits and evaluate the safety and preliminary effectiveness of the Braive™ GMS when used in the treatment of pediatric progressive scoliosis.
- Trial name
- BRAIVE IDE (NCT04929678)
- Testing
- Braive™ Growth Modulation System (Braive™ GMS)
- Where
- 4 sites in United States, Canada and 1 more
- Volunteers
- 10 people
- Sponsor
- Medtronic Spinal and Biologics