Clinical trials: Lumbar Fusion
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 Disc Disease, Spondylolisthesis
Prospective, Multi-center Study to Assess Posterolateral Fusion Using FIBERGRAFT
This is a prospective, non-randomized (single arm), multi-center, post-market clinical study designed to evaluate FIBERGRAFT® BG Matrix mixed with autograft and bone marrow aspirate in up to 150 subjects with degenerative disc…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis Lumbar
- Trial name
- NCT03884283
- Testing
- FIBERGRAFT BG Matrix
- Where
- 9 sites in United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Prosidyan, Inc.
Degenerative Disc Disease
A Pilot Study of rhBMP-2/ACS With the INTERFIX™ Device for the AnteriorLumbar Interbody Fusion in Patients With Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate the device design as a method of facilitating spinal fusion.
- Trial name
- NCT01491451
- Testing
- rhBMP-2/ACS/INTERFIX™, Autogenous bone/INTERFIX™
- Volunteers
- 45 people
- Sponsor
- Medtronic Spinal and Biologics
Degeneration of Lumbar Intervertebral Disc
Comparison of the Aspen Device Versus Pedicle Screws for Supplemental Posterior Fixation in Lumbar Interbody Fusion
The purpose of this clinical investigation is to evaluate the Aspen™ device compared to pedicle screw instrumentation for posterior fixation in the treatment of patients with degenerative disc disease and/or spondylolisthesis.
- Trial name
- NCT01549366
- Testing
- Aspen Spinous Process Fixation Device, Pedicle Screws
- Where
- 3 sites in United States
- Volunteers
- 64 people
- Sponsor
- Zimmer Biomet
Pseudoarthrosis, Spinal Stenosis
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an…
- Conditions
- Pseudoarthrosis, Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- Trial name
- NCT01972256
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Baxano Surgical, Inc.
Transforaminal Lumbar Interbody Fusion Surgery
A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.
The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery.
- Trial name
- NCT06204900
- Testing
- Nerve Cuff and Retractor System
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Retropsoas Technologies, LLC
Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00810212
- Testing
- PLF with autograft, PLF with NeoFuse
- Where
- United States
- Sponsor
- Mesoblast, Ltd.
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
PMCF Study Fortilink-TS Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-TS Ti cage of Paradigm Spine GmbH, up to one-year after the surgery.
- Trial name
- NCT07834736
- Testing
- Posterior lumbar interbody fusion surgery
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Degenerative Disc Disease, Lumbar
Osteocel® Plus in Anterior Lumbar Interbody Fusion (ALIF)
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in an ALIF procedure.
- Trial name
- NCT00948831
- Testing
- Osteocel Plus
- Where
- 7 sites in United States
- Volunteers
- 51 people
- Sponsor
- NuVasive
Degenerative Disc Disease
INFUSE® Bone Graft and MASTERGRAFT® Granules With CD HORIZON® for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease - Pilot Study
The purpose of this pilot clinical trial is to evaluate the feasibility of using the investigational implant (INFUSE® Bone Graft and MASTERGRAFT® Granules with the CD HORIZON® Spinal System) as a method of facilitating spinal…
- Trial name
- NCT01491542
- Testing
- INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®, Autogenous Bone / CD HORIZON® Spinal System
- Volunteers
- 46 people
- Sponsor
- Medtronic Spinal and Biologics
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
Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients…
- Trial name
- NCT01494441
- Testing
- rhBMP-2/BCP, rhBMP-2/BCP/TSRH® Spinal System, Autograft/TSRH® Spinal System
- Volunteers
- 27 people
- Sponsor
- Medtronic Spinal and Biologics
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.
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.
Scoliosis, Scoliosis; Adolescence
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS)…
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region
- Trial name
- PKSforPSP (NCT06554093)
- Testing
- Medical Device - PKS
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Deep Health Ltd.
Lumbar Spine Degeneration
3Spine Lumbar Fusion Real World Evidence Study
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF)…
- Trial name
- NCT04823858
- Testing
- Lumbar Interbody Fusion
- Where
- 20 sites in United States
- Volunteers
- 176 people
- Sponsor
- 3Spine
Lumbar Spine Degeneration
Study Using the SpinalStim Device Following Lumbar Fusion Surgery
This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on lumbar fusion rate in high risk subjects who have had lumbar fusion surgery.
- Trial name
- NCT03176303
- Testing
- SpinalStim
- Where
- United States
- Volunteers
- 206 people
- Sponsor
- Orthofix Inc.
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft…
- Conditions
- Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- STABILITY (NCT06355791)
- Testing
- Minuteman G5 Device
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Spinal Simplicity LLC
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