Clinical trials: Spine 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
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.
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.
Spinal Diseases
Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine.
- Trial name
- PDL (NCT00295009)
- Testing
- ProDisc, Spinal Fusion
- Volunteers
- 852 people
- Sponsor
- Synthes USA HQ, 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
Spinal Deformity, Spinal Degenerative Disorder
The Ailliance Post-Market Clinical Study
The purpose of this clinical study is to collect performance and safety data for post-market Medtronic devices indicated for cranial and/or spinal indication(s). Subjects are enrolled and followed postoperatively to 24 months.
- Conditions
- Spinal Deformity, Spinal Degenerative Disorder, Spinal Fusion Failure, Spinal Trauma
- Trial name
- NCT05856370
- Testing
- Follow-up schedule: pre-operative baseline up to 24-months post-procedure
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 1,000 people
- Sponsor
- Medtronic Spinal and Biologics
Single Level Posterolateral Spinal Fusion
Use of TRC Autologous Bone Marrow Cells in Posterolateral Lumbar Spine Fusion
The hypothesis is that Aastrom TRC autologous bone marrow tissue "grafts" can be safely used to promote bone healing as part of a single level posterolateral spine fusion surgical procedure.
- Trial name
- NCT00797550
- Testing
- Bone Repair Cells (BRCs), Autologous bone graft
- Volunteers
- 2 people
- Sponsor
- Vericel Corporation
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Idys™ TLIF 3DTi Post Market Clinical Follow-up
The aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of Idys™ TLIF 3DTi at up to 24 months post transforaminal lumbar fusion in usual surgical practice.
- Trial name
- NCT04584619
- Testing
- Spine fusion surgery with Clariance Idys TLIF 3DTi
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Clariance
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
Spondylosis, Spinal Stenosis
A Prospective Study of NuCel® in Cervical Spine Fusion
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
- Conditions
- Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease
- Trial name
- NCT02381067
- Testing
- NuCel with Allograft Bone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- NuTech Medical, Inc
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
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
Scoliosis
Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis
The purpose of this clinical trial is to study a new method of treatment for patients who are diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine.
- Trial name
- NCT01465295
- Testing
- Mechanical hemiepiphysiodesis using the HemiBridge System
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- SpineForm LLC
Degenerative Disc Disease, Spondylolisthesis
Pilot Study to Assess Safety/Preliminary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from…
- Trial name
- NCT00798902
- Testing
- Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- BioSurface Engineering Technologies, 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
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
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
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