Clinical trials: Lumbar Fusion
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Degenerative Disc Disease, Back Pain
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels.
- Trial name
- NCT00948532
- Testing
- biologic, Osteocel Plus
- Where
- 13 sites in United States
- Volunteers
- 104 people
- Sponsor
- NuVasive
Degenerative Disc Disease
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied…
- Trial name
- NCT03438747
- Testing
- P-15L Bone Graft, Local autologous bone in a TLIF with Instrumentation
- Where
- 34 sites in United States
- Volunteers
- 290 people
- Sponsor
- CeraPedics, Inc
Degenerative Disc Disease, Spinal Stenosis
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT00762723
- Testing
- Trinica Anterior Lumbar Plate System
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Spinal Stenosis
SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Scoliosis
- Trial name
- NCT04566874
- Testing
- ALIF
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Camber Spine Technologies
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.
Degenerative Disc Disease
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients With Lumbar Degenerative Disc Disease
Efficacy and Safety of Novosis Putty in Transforaminal Lumbar Interbody Fusion for Patients with Lumbar Degenerative Disc Disease : A Pivotal, Randomized, Prospective, Multi-Center Study
- Trial name
- NCT07017634
- Testing
- Novosis Putty, Standard of Care
- Where
- 10 sites in United States
- Volunteers
- 316 people
- Sponsor
- CGBio Inc.
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Intervertebral Disc Degeneration, Spinal Fusion
A Post Market Surveillance on INFUSE Bone Graft
This study aims to evaluate the safety and effectiveness of INFUSE™ Bone Graft in the real-world setting in Korea.
- Conditions
- Intervertebral Disc Degeneration, Spinal Fusion, Lumbar Disc Disease
- Trial name
- NCT05299762
- Testing
- INFUSE™ Bone Graft
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
Clinical Evaluation of Orion Lamina Cover in Patients Undergoing Lumbar Laminectomy With Instrumented Fusion
Laminectomy with internal fixation and osseofusion is a common surgery for treating degenerative spinal diseases. It removes excessive bone spurs and removes the lamina for decompression to relieve nerve compression, and then…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Spondylolisthesis, Spinal Stenosis, Scoliosis
- Trial name
- NCT06532968
- Testing
- ORION spinal lamina cover
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Orion Biotech Inc.
Degenerative Disc Disease
Comparative Analysis of Virtuos and Autograft in Lumbar Fusion
Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental…
- Trial name
- NCT05614284
- Testing
- Virtuos
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Orthofix Inc.
Lumbar Spinal Stenosis, Spondylolisthesis
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. This causes discomfort in the legs when standing or walking because of pressure on the spinal nerves.There are…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT01455805
- Testing
- Minuteman Fusion Implant, surgical decompression
- Where
- 4 sites in United Kingdom
- Volunteers
- 48 people
- Sponsor
- Spinal Simplicity LLC
Degenerative Disc Disease
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion (PLIF) With Interbody Fusion
The primary objective of this clinical trial is to evaluate the success rates of Actifuse ABX and INFUSE in achieving bone fusion. The secondary objective of this clinical trial is to assess clinical outcome measurements.
- Trial name
- APPRAISET1 (NCT01013389)
- Testing
- Actifuse ABX, INFUSE, plus master granules (MGG)
- Where
- 2 sites in Australia, Netherlands
- Volunteers
- 20 people
- Sponsor
- Baxter Healthcare Corporation
Degenerative Disc Disease
Virtuos Bone Graft in Lumbar Fusion
A post-market open label study to assess the efficacy of a cellular based allograft bone graft in lumbar spinal fusion at one or two levels
- Trial name
- NCT06686017
- Where
- 9 sites in United States
- Volunteers
- 150 people
- Sponsor
- Orthofix Inc.
Spondylosis, Spondylolisthesis
Comparison of Radiographic Fusion Rate and Clinical Outcome of ALIF and XLIF Performed With Either Recombinant Human Bone Morphogenetic Protein-2 or ViviGen®
The aim of this study is to prospectively investigate the potential for bony fusion of ViviGen® bone graft substitute in comparison to rhBMP-2 in monosegmental ALIF procedure L5/S1 and in monosegmental XLIF procedure L4/5
- Conditions
- Spondylosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT05238740
- Testing
- ViviGen®, rhBMP-2
- Where
- Switzerland
- Volunteers
- 168 people
- Sponsor
- Lindenhofgruppe AG
Degenerative Disc Disease
Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic degenerative disc disease using an open…
- Trial name
- NCT01491386
- Testing
- rhBMP-2/ACS/LT-CAGE® Device, Autogenous Bone/LT-CAGE® Device
- Volunteers
- 279 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level…
- Trial name
- NCT02104141
- Testing
- ROIA Interbody Cage with VerteBRIDGE plating
- Volunteers
- 51 people
- Sponsor
- LDR Spine USA
Spinal Disease, Degenerative Disc Disease
OssiMend BA in Posterolateral Instrumented Lumbar Fusion
The primary objective of this study is to measure the success rate of lumbar fusion in subjects at 12 months when instrumented lumbar arthrodesis is performed using OssiMend Bioactive Moldable as the bone grafting material
- Trial name
- NCT04775537
- Testing
- OssiMend™ Bioactive Moldable
- Where
- 4 sites in United States
- Volunteers
- 120 people
- Sponsor
- Collagen Matrix
Spinal Stenosis, Spondylolisthesis
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in…
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- Trial name
- NCT02171169
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Baxano Surgical, Inc.
Lumbar Degenerative Disc Disease
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.
- Trial name
- NCT01293981
- Testing
- PureGen Osteoprogenitor Cell Allograft
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Alphatec Spine, Inc.