Clinical trials: Spondylolysis
Degenerative Disc Disease, Spondylolisthesis
Safety and Efficacy of the CarboFix Pedicle Screw System
The purpose of this study is to evaluate the safety and efficacy of CarboFix' Pedicle Screw System in the lumbar spine.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Curvatures
- Trial name
- NCT02039232
- Testing
- Pedicle screw system
- Where
- 2 sites in Israel
- Volunteers
- 46 people
- Sponsor
- CarboFix Orthopedics Ltd.
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Osteochondrosis
MySpine MC Versus MySpine Standard
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique.
- Conditions
- Degenerative Disc Disease, Osteochondrosis, Spondylolysis Lumbar
- Trial name
- MC vs STD (NCT05846477)
- Testing
- MySpine
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- Medacta International SA
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Kore Fiber PLF Study
This is a prospective, randomized controlled trial evaluating Kore Fiber® versus autograft in adults undergoing posterolateral lumbar fusion (PLF).
- Conditions
- Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT07868510
- Testing
- Kore Fiber, Autologous bone graft
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Kolosis Bio, LLC
Degenerative Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
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, Spondylolisthesis
Spine Registration Using 3D Scanning - Arise
The primary objective is to assess the capability of the device as measured by its consistency, its accuracy, and feedback from surgical staff over the study period.
- Conditions
- Spinal Fusion, Spondylolisthesis, Scoliosis, Sciatica
- Trial name
- NCT05195593
- Testing
- Optical 3D Scanner
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- Advanced Scanners Inc.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00996073
- Testing
- Lumbar Interbody Fusion with Autograft, Lumbar Interbody Fusion with NeoFuse
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mesoblast, Ltd.
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.
Prolapsed Lumbar Disc, Prolapsed Cervical Disc
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and…
- Conditions
- Prolapsed Lumbar Disc, Prolapsed Cervical Disc, Intervertebral Disc Degeneration, Spondylolisthesis, Grade 1
- Trial name
- NCT01944345
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- Wenzel Spine
Lumbar Spinal Stenosis, Spondylolisthesis
Post-market Study of the TOPS™ System
This Single-Arm Post-Marketing Evaluation will gauge the improvement in function and pain for lumbar spinal stenosis and spondylolisthesis patients with the TOPS System.
- Trial name
- NCT02234154
- Testing
- TOPS System
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Premia Spine
Spondylolisthesis
XLIF® vs. MAS®TLIF for the Treatment of Symptomatic Lumbar Degenerative Spondylolisthesis With or Without Central Stenosis.
The purpose of this study is to determine differences in the XLIF and TLIF procedures with respect to perioperative variables in adult patients with low-grade symptomatic spondylolisthesis.
- Trial name
- NCT01024699
- Where
- 9 sites in United States
- Volunteers
- 55 people
- Sponsor
- NuVasive
Lumbar Spinal Stenosis, Spondylolisthesis
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple…
- Trial name
- SPSI (NCT03754972)
- Testing
- Sagittal plane shear index (SPSI)
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Medical Metrics Diagnostics, Inc
Low Back Pain, Spondylolisthesis
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
Lumbar spinal fusion is commonly performed as a "last resort" in patients with chronic low back pain caused by degenerative changes and instability of the spine.
- Conditions
- Low Back Pain, Spondylolisthesis, Spinal Stenosis, Intervertebral Disc Displacement
- Trial name
- NCT00095095
- Testing
- Lumbar Interbody Fusion
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 102 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spine Disease, Lumbar Spondylolisthesis
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar…
- Conditions
- Lumbar Spine Disease, Lumbar Spondylolisthesis, Lumbar Spine Instability, Lumbar Spondylosis
- Trial name
- SELECT (NCT05405374)
- Testing
- OSTEOAMP, Infuse
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Bioventus LLC
Cervical Stenosis, Spondylolisthesis
Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
- Conditions
- Cervical Stenosis, Spondylolisthesis, Cervical Radiculopathy, Cervical Disc Disorder
- Trial name
- NCT04684901
- Testing
- AlloWrap® Amniotic Membrane
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AlloSource
Degenerative Disc Disease, Spondylolisthesis
Study of Nucel for One and Two Level Lumbar Interbody Fusion
The study is a prospective non-randomized multi-center feasibility clinical trial to establish the safety and efficacy of the Nucel® allograft tissue for use in lumbar interbody fusion procedures.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spondylosis
- Trial name
- NCT02808234
- Testing
- One or two level lumbar interbody fusion surgery, Nucel
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Organogenesis
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
PMCF Study Fortilink-TC Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-TC Ti cage of Paradigm Spine GmbH, up to one year after the surgery.
- Trial name
- NCT07834931
- Testing
- Transforaminal lumbar interbody fusion surgery
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Spondylosis, Spondylolisthesis
Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
This is a single-arm post-market study in patients requiring lumbar fusion using allograft interbody spacer in conjunction with map3® Cellular Allogeneic Bone Graft in patients with degenerative disc disease (DDD).
- Conditions
- Spondylosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT02628210
- Testing
- map3® Cellular Allogeneic Bone Graft
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- RTI Surgical
Lumbar Spinal Stenosis, Spondylolisthesis
Post-market Study of the TOPS™ System
The study is being conducted to evaluate look the TOPS System when used in patients with degenerative spondylolisthesis and lumbar spinal stenosis who would normally be candidates for spinal fusion.
- Trial name
- TOPS (NCT01933607)
- Testing
- TOPS System
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Premia Spine