Clinical trials: Deformity of Spine
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
Degenerative Disc Disease(DDD)
Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease
The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF)…
- Trial name
- SECOND (NCT07721493)
- Testing
- Circumferential Cervical Fusion (CCF), Anterior Cervical Discectomy and Fusion
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- Providence Medical Technology, Inc.
Sacroiliac Joint Disruption, Scoliosis Lumbar Region
SI Joint Stabilization in Long Fusion to the Pelvis
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
- Trial name
- SILVIA (NCT04062630)
- Testing
- iFuse 3-D in Bedrock Configuration, Multilevel Lumbar Fusion surgery
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 213 people
- Sponsor
- SI-BONE, Inc.
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
Spinal Fusion, Deformity of Spine
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
- Trial name
- PAULA (NCT05640908)
- Testing
- iFuse Bedrock Granite Implant System
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- SI-BONE, Inc.
Spondylosis, Spinal Stenosis
A Prospective Study of NuCel® in Cervical Spine Fusion
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
- Conditions
- Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease
- Trial name
- NCT02381067
- Testing
- NuCel with Allograft Bone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- NuTech Medical, Inc
Degenerative Spinal Disease, Deformity of Spine
Fenestrated Screw Study
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal…
- Trial name
- FNS (NCT03797144)
- Testing
- CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
- Where
- 6 sites in Belgium, Finland and 3 more
- Volunteers
- 27 people
- Sponsor
- Medtronic Spinal and Biologics
Adolescent Idiopathic Scoliosis
MESA Rail™ AIS Study - Preservation of Curve Correction
To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for…
- Trial name
- NCT02062606
- Testing
- MESA Rail™ Deformity System
- Volunteers
- 188 people
- Sponsor
- K2M, Inc.
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.
Spinal Deformity
Pedicle Screw Positioning With MySpine vs Free Hand Technique
Randomized clinical study in order to evaluate the accuracy of pedicle screw positioning during spine surgery performed with MySpine patient match positioning guide or Free hand technique.
- Trial name
- NCT03369158
- Testing
- patient specific pedicle screw positioning guide, Free hand technique pedicle screw positioning, MUST pedicle screw
- Volunteers
- 29 people
- Sponsor
- Medacta International SA
Spinal Deformity, Spinal Degenerative Disorder
The Ailliance Post-Market Clinical Study
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months.
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma
- Trial name
- NCT05856370
- Testing
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Spinal and Biologics
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
Degenerative Spine Disease, Spinal Deformity
Prospective, Observational Registry of Renaissance-guided Spine Surgeries
To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
- Trial name
- NCT02212899
- Where
- 4 sites in United States
- Volunteers
- 93 people
- Sponsor
- Mazor Robotics
Osteogenesis Imperfecta
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
- Trial name
- OI (NCT02352753)
- Testing
- Denosumab
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 153 people
- Sponsor
- Amgen
Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases.
- Conditions
- Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis, Spinal Deformity, Spinal Degeneration
- Trial name
- PASS DEGEN (NCT04670536)
- Testing
- PASS LP implants, PASS DEGEN, PASS TULIP PRIME
- Where
- 4 sites in France
- Volunteers
- 77 people
- Sponsor
- Medicrea International
Degenerative Disc Disease
Study of Posterior Cervical Stabilization System (PCSS) as Part of Circumferential Fusion to Treat Multilevel DDD
This study will evaluate the safety and effectiveness of a device called "Posterior Cervical Stabilization System or PCSS" when used along with posterior cervical fusion (PCF) in combination with anterior cervical discectomy and…
- Trial name
- FUSE (NCT04229017)
- Testing
- Anterior Cervical Discectomy and Fusion, Posterior Cervical Stabilization System (PCSS)
- Where
- 17 sites in United States
- Volunteers
- 236 people
- Sponsor
- Providence Medical Technology, Inc.
Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
This postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral…
- Conditions
- Acute Instabilities Thoracic, Lumbar and Sacral Spine, Chronic Instabilities Thoracic, Lumbar and Sacral Spine, Deformities of the Thoracic, Lumbar and Sacral Spine
- Trial name
- NCT02184520
- Testing
- TRANSITION, REVERE
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Globus Medical Inc
Spinal Deformity
Post Market Surveillance to Evaluate the Effectiveness the Polaris Deformity Spinal System
The purpose of this Post Market Surveillance Validation is to document the performance and clinical outcomes of the Polaris Deformity Spinal System \& Trivium 3D Spinal Deformity Correction System.
- Trial name
- NCT01220505
- Testing
- Surgery
- Where
- 6 sites in United States, Puerto Rico
- Volunteers
- 66 people
- Sponsor
- Zimmer Biomet
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Spinal Fusion
Artoss Prospective Spine Registry Outcomes
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.
- Trial name
- ASTRO (NCT04439032)
- Testing
- NanoBone Bone Graft Substitute
- Where
- 6 sites in United States
- Volunteers
- 330 people
- Sponsor
- Artoss Inc.