Clinical trials: Fusion of Spine
Lumbar Degenerative Disc Disease
Percutaneous Dynamic Stabilization (PDS) System Versus Fusion for Treating Degenerative Disc Disease
The objective of this study is to evaluate the safety and effectiveness of the PDS System compared to the surgical control of posterolateral fusion with autograft and pedicle screw fixation for the treatment of one or two levels…
- Trial name
- NCT00878579
- Testing
- PDS System, Fusion
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Interventional Spine, Inc.
Spinal Fusion Acquired, Fusion of Spine (Disease)
Efficacy and Safety of SurgiFill™ on Spinal Fusion
This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.
- Trial name
- NCT02466048
- Testing
- Spinal Fusion, SurgiFill™
- Where
- 2 sites in South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Intervertebral Disc Disease, Intervertebral Disc Degeneration
Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
- Conditions
- Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis
- Trial name
- NCT02023372
- Testing
- NuCel with Autograft
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- NuTech Medical, Inc
Spinal Fusion, Pain Management
PK Study of EXPAREL in Subjects Undergoing Open Spinal Fusion or Reconstructive Surgery
The primary objective of this study is to characterize the pharmacokinetic (PK) profile of EXPAREL when administered via local wound infiltration to subjects undergoing open spinal fusion or reconstructive surgery.
- Trial name
- NCT02985762
- Testing
- EXPAREL
- Where
- 3 sites in United States
- Volunteers
- 15 people
- Sponsor
- Pacira Pharmaceuticals, Inc
OsteoFlo HydroFiber
OsteoFlo HydroFiber Ambispective Evaluation
The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine.
- Trial name
- NCT07784673
- Testing
- OsteoFlo HydroFiber
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- SurGenTec LLC
Degenerative Spine Disease
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level…
- Trial name
- NCT07059065
- Testing
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix
- Where
- 5 sites in United States
- Volunteers
- 316 people
- Sponsor
- DePuy Synthes Products, Inc.
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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.
Spine Fusion
Pedicle Screw Placement With XVS
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.
- Trial name
- NCT04682418
- Testing
- xvision Spine sytem
- Where
- 3 sites in Israel
- Volunteers
- 19 people
- Sponsor
- Augmedics
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, Inc.
Spinal Fusion, Spinal Stenosis
Spine Registration Using 3D Scanning
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, Spinal Stenosis, Scoliosis, Spondylolisthesis
- Trial name
- NCT05195580
- Testing
- Optical 3D Scanner
- Where
- United States
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Advanced Scanners Inc.
Intraoperative Hypotension
Feasibility Study of E-Fusion Vasopressor Titration-Assist During Multi-Level Spine Surgery
This is a single-arm feasibility study of E-Fusion Vasopressor Titration-Assist, a clinical decision support software, in 10 adults undergoing multi-level spine surgery.
- Trial name
- NCT07840937
- Testing
- E-Fusion Vasopressor Titration-Assist
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Autonomous Healthcare, Inc.
Spondylolisthesis, Scoliosis
A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion.
- Conditions
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- Trial name
- NCT02225444
- Testing
- OsteoAMP
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Bioventus LLC
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Craniocervical Injuries
Posterior Cervical Fixation Study
The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported…
- Conditions
- Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease
- Trial name
- NCT04770571
- Testing
- observational study
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive
Fusion of Spine (Disease), Fractures, Ununited
A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.
- Trial name
- NCT01750840
- Testing
- Biomet® EBI Bone Healing System, Biomet Orthopak® Non-Invasive Bone Growth Stimulator System, Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Zimmer Biomet
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
Degenerative Conditions of the Lumbar Spine
AttraX® Putty vs. Autograft in XLIF®
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
- Trial name
- NCT02250248
- Testing
- AttraX Putty, Iliac Crest Bone Graft (ICBG)
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- NuVasive
Degenerative Disc Disease
CHARITÉ™ Artificial Disc Compared to Anterior Interbody Fusion for Treatment of Degenerative Disc Disease
The study is designed to evaluate the safety and effectiveness of the CHARITE Artificial Disc compared to anterior lumbar interbody fusion for treatment of degenerative disc disease at one level of the lumbar spine (either L4/L5…
- Trial name
- NCT00215306
- Testing
- CHARITÉ Artificial Disc, Anterior Interbody Fusion with BAK Cage
- Volunteers
- 304 people
- Sponsor
- DePuy Spine
Degenerative Disc Disease
Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
- Trial name
- NCT05972616
- Testing
- Natural Matrix Protein (NMP)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Induce Biologics USA Inc.