Clinical trials: Scoliosis
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
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.
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
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
Adolescent Idiopathic Scoliosis
Safety and Efficacy Study of Spinal Tethering
This study is an opportunity to gather long term safety and efficacy information from patients who have had their scoliosis treated via anterior vertebral body tethering (VBT).
- Trial name
- NCT02897453
- Testing
- The Spinal Tethering System
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Adolescent Idiopathic Scoliosis
Treatment of Adolescent Idiopathic Scoliosis Patients Using the Ellipse MAGEC System
The purpose of this study is to collect data on the use of the Ellipse MAGEC System to treat patients with adolescent idiopathic scoliosis (AIS) who have failed external brace therapy.
- Trial name
- NCT01633931
- Where
- Hong Kong
- Volunteers
- 20 people
- Sponsor
- Ellipse Technologies, Inc.
Degenerative Disc Disease, Degenerative Scoliosis
Clinical Outcome Measure at Stryker Spine
This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions…
- Trial name
- COMPASS (NCT06226272)
- Testing
- Spinal Fusion, Spinal Deformities Correction
- Where
- 7 sites in United States
- Volunteers
- 5,222 people
- Sponsor
- VB Spine, LLC
Adolescent Idiopathic Scoliosis (AIS)
Feasibility Study of MID-C for AIS
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.
- Trial name
- MID-C (NCT03071445)
- Where
- 3 sites in Hungary, Romania
- Volunteers
- 13 people
- Sponsor
- Apifix
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.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
Degenerative Disc Disease
Interbody Systems: Post Market Clinical Follow-up Study
This is a prospective, multi-center study of subjects who will undergo spinal fusion surgery utilizing Stryker Interbody Systems that require post market clinical follow up (PMCF).
- Trial name
- NCT04911257
- Testing
- Cervical or Lumbar Spinal fusion
- Where
- 4 sites in United States
- Volunteers
- 28 people
- Sponsor
- K2M, Inc.
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.
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
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
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
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
Degenerative Disc Disease, Degenerative Spondylolisthesis
Modulus in XLIF Study
The primary objective of this study is to evaluate the safety and performance of the Modulus 3D-printed titanium interbody implant in patients undergoing thoracic and/or lumbar XLIF as measured by reported complications…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT04418817
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- NuVasive
Scoliosis
Robotic vs. Freehand Corrective Surgery for Pediatric Scoliosis
To compare the accuracy and feasibility, curvature correction and clinical outcomes of pedicle screw instrumentation with versus without robotic guidance, in pediatric and adolescent scoliosis patients
- Trial name
- PEDSCOLI (NCT02084264)
- Where
- 4 sites in United States
- Volunteers
- 272 people
- Sponsor
- Mazor Robotics
Spondylolisthesis, Scoliosis
A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion.
- Conditions
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- Trial name
- NCT02225444
- Testing
- OsteoAMP
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Bioventus LLC
Degenerative Disc Disease, Scoliosis
OLIF25™ /OLIF51™ Study
The purpose of this single-arm observational study is to observe and document clinical outcomes of the OLIF25™ and OLIF51™ procedures in patients diagnosed with degenerative disc disease or degenerative scoliosis, and report the…
- Trial name
- NCT02657421
- Testing
- Oblique Lateral Interbody Fusion
- Where
- 12 sites in United States, Belgium and 5 more
- Volunteers
- 168 people
- Sponsor
- Medtronic Spinal and Biologics