Clinical trials: Spine Fusion
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
A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
- Trial name
- NCT00678171
- Testing
- TLIF with a PEEK Spacer System and XIA Spinal System
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Olympus Biotech Corporation
Intervertebral Disc Degeneration
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal…
- Trial name
- TLIF (NCT05997121)
- Testing
- Transforaminal lumbar interbody fusion
- Where
- 6 sites in France, Switzerland
- Volunteers
- 187 people
- Sponsor
- SPINEVISION SAS
Lumbar Spinal Stenosis
Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal…
- Trial name
- NCT00529997
- Testing
- Stabilimax NZ® Dynamic Spine Stabilization System
- Where
- 19 sites in United States
- Volunteers
- 480 people
- Sponsor
- Applied Spine Technologies
Degenerative Disc Disease, Lumbar Disc Disease
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of…
- Conditions
- Degenerative Disc Disease, Lumbar Disc Disease, Spine Disease, Lumbar Spine Degeneration
- Trial name
- RESTORE (NCT06462729)
- Testing
- LDGraft, Allograft Bone
- Where
- 4 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Locate Bio Pty 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, 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.
Degenerative Disc Disease, Spondylolisthesis
Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft.
The objectives of this longitudinal study are to assess and measure fusion status (fused or not fused) and rate of bony fusion using NanoBone® Synthetic Bone Graft in patients requiring one to two level lumbar posterolateral…
- Trial name
- BONE (NCT04615260)
- Testing
- NanoBone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Artoss Inc.
Lumbar Facet Disease
A Post-Market Study of Transfacet Lumbar Spine Fixation and Fusion Utilizing the PERPOS™ PLS System
The purpose of this study is to utilize the PERPOS™ PLS System for transfacet lumbar spine fixation to evaluate its effect on patients' level of pain, procedural complications and functional status.
- Trial name
- NCT00887835
- Testing
- PERPOS™ PLS
- Volunteers
- healthy volunteers welcome
- Sponsor
- Interventional Spine, Inc.
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
Degenerative Disc Disease
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device.
- Trial name
- NCT00389597
- Testing
- Cervical Artificial Disc
- Where
- 24 sites in United States
- Volunteers
- 599 people
- Sponsor
- LDR Spine USA
Sacroiliac; Fusion, Sacroiliac
Prospective SPINE Registry
This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.
- Conditions
- Sacroiliac; Fusion, Sacroiliac, Joint Diseases, Musculoskeletal Diseases
- Trial name
- SPINE (NCT04176562)
- Testing
- RTI Spine products
- Where
- 12 sites in United States, Germany and 1 more
- Volunteers
- 5,000 people
- Sponsor
- Xtant Medical
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
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.
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, 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
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.
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
Fusion of Spine, Sacroiliac; Fusion
Lumbar & Sacroiliac Fusion Study Involving Previously Implanted Devices
This study is a multi-center, observational, prospective and retrospective data collection study
- Trial name
- FUSION (NCT07204288)
- Testing
- Cat Scan, if applicable
- Where
- 3 sites in United States
- Volunteers
- 500 people
- Sponsor
- Spinal Simplicity LLC
Intervertebral Disc Degeneration, Stenosis, Spinal
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk…
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity
- Trial name
- NCT05648474
- Testing
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alphatec Spine, Inc.