Clinical trials: Thoracolumbar
Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders
Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
This study was designed to evaluate the efficacy and safety of Medicurtain®, an antiadhesion barrier in patients who underwent In Situ Decompression for single level and unilateral herniated lumbar intervertebral disc.
- Conditions
- Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders, Thoracolumbar Intervertebral Disc Disorders, Lumbosacral Intervertebral Disc Disorders
- Trial name
- NCT04688281
- Testing
- Medicurtain®, GUARDIX-SG®
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Fused Vertebrae, Ankylosing Spondylitis
Clinical Investigation of MONTAGE in Adults With Spinal Deformity Undergoing Pedicle Subtraction Osteotomy
This study evaluates the difference in postoperative bleeding between two study groups, FDA cleared MONTAGE Settable Resorbable Hemostatic Bone Putty and standard of care (no bone hemostat) during pedicle subtraction osteotomy…
- Conditions
- Fused Vertebrae, Ankylosing Spondylitis, Sagittal Deformities, Thoracolumbar Kyphosis
- Trial name
- NCT04125147
- Testing
- Experimental: Montage Bone Hemostat
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Abyrx, Inc.
SPINAL Fracture, Vertebral Fractures
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients…
- Conditions
- SPINAL Fracture, Vertebral Fractures, Spinal Stenosis, Kyphosis
- Trial name
- NCT06153511
- Testing
- Robot assisted spinal transpedicular fixation
- Where
- Spain
- Volunteers
- 13 people
- Sponsor
- Cyber Surgery S.L.
Spine Surgery
Comprehensive Spinal Alignment Planning Study
A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied.
- Trial name
- NCT02606695
- Testing
- NuvaMap O.R., NuvaMap
- Where
- 15 sites in United States
- Volunteers
- 306 people
- Sponsor
- NuVasive
Degenerative Spinal Conditions
A Pre-market Study to Evaluate b.Bone for Posterolateral Fusion (b.Spine Clinical Trial).
Prospective, open-label, single-arm clinical investigation. The purpose of this clinical investigation is to evaluate the bone substitute b.Bone in posterolateral fusion treatment of degenerative thoracolumbar, lumbar or…
- Trial name
- NCT05906394
- Testing
- Posterolateral Fusion
- Where
- 2 sites in Germany, Italy
- Volunteers
- 16 people
- Sponsor
- GreenBone Ortho S.p.A.
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
Intervertebral Disc Degeneration
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal…
- Trial name
- FixedD3 (NCT06342765)
- Testing
- Pedicle fixation surgery
- Where
- 3 sites in France
- Volunteers
- 330 people
- Sponsor
- SPINEVISION SAS
Proximal Junctional Kyphosis, Spino-pelvic Alignment
MSK Validation Study
Spinal posture and imbalance are known to be related to increased muscle expenditure, with narrow "cone of economy" of muscle effort defining the most comfortable postures.
- Conditions
- Proximal Junctional Kyphosis, Spino-pelvic Alignment, Thoracolumbar Spinal Fusion
- Trial name
- MSK (NCT04422288)
- Where
- 2 sites in United States
- Volunteers
- 200 people
- Sponsor
- NuVasive
Thoracolumbar Spine, Cervical Spine Injury
Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems
This is a retrospective and prospective observational, multi center study of subjects who have undergone or will undergo vertebral body replacement surgery in the cervical or thoracolumbar spine utilizing Stryker Capri Corpectomy…
- Trial name
- NCT05456633
- Testing
- Capri Cervical Static, CAPRI Static Expandable, Capri Thoracolumbar
- Sponsor
- K2M, Inc.
Spinal Fractures
PASS MIS® Post-market Clinical Follow-up
Prospective, multicenter non comparative and observational study (post-market clinical follow-up).
- Trial name
- NCT02931266
- Testing
- PASS MIS®
- Where
- France
- Volunteers
- 5 people
- Sponsor
- Medicrea International
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
Osteoporotic Fracture of Vertebra
Safety and Efficacy of the ISS Sleeve Augmentation Technique in the Treatment of Thoracolumbar Osteopenic Fractures
Implant anchorage is difficult in patient with osteoporotic bone. To improve the implant bone interface, the ISS stabilization system has been developed.
- Trial name
- NCT04495439
- Testing
- Augmentation with the ISS Study System, Augmentation with PMMA
- Where
- Austria
- Volunteers
- 2 people
- Sponsor
- Nexilis AG
Thoracic Fracture, Lumbar Fracture
Minimally Invasive Reduction and Fixation of Thoracolumbar Fractures
Spinal injuries, such as vertebral fractures, often result in a significant instability of the spine and lead to acute or delayed neurological deficits.
- Trial name
- FRIFIX (NCT01810094)
- Testing
- Fracture Fixation
- Where
- 4 sites in Germany
- Volunteers
- 24 people
- Sponsor
- Aesculap AG
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Trial name
- PROOF (NCT04679844)
- Testing
- MagnetOs Easypack Putty, Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Kuros Biosurgery AG