Clinical trials: Fusion of Spine, Lumbar Region
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.
Vitamin D, Spinal Fusion
The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported to be associated with more…
- Conditions
- Vitamin D, Spinal Fusion, Lumbar Spine Disease
- Trial name
- NCT05023122
- Testing
- vitamin D3, calcium
- Where
- Taiwan
- Volunteers
- 34 people
- Sponsor
- Show Chwan Memorial Hospital
Paraspinal Muscles, Degenerative Lumbar Diseases
The Impact of Paraspinal Muscle Atrophy in Spine Surgeries
The goal of this observational study is to learn about the role of pre-operative paraspinal muscle atrophy in outcomes of lumbar spine fusion surgeries in patients with degenerative lumbar spine diseases.
- Trial name
- NCT07002918
- Where
- Egypt
- Volunteers
- 55 people
- Sponsor
- Assiut University
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
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.
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.
Spondylolisthesis, Degenerative Lumbar Disc Disease
Spine Research With Roentgen Stereophotogrammetric Analysis
The purpose of this study is to gather information on the effectiveness of a new spine implant for patients who require spinal fusion surgery.
- Conditions
- Spondylolisthesis, Degenerative Lumbar Disc Disease, Spinal Stenosis
- Trial name
- SpineRSA (NCT00493558)
- Testing
- Trabecular Metal Intervertebral Cage with RSA beads
- Where
- Canada
- Volunteers
- 17 people
- Sponsor
- Nova Scotia Health Authority
Degenerative Lumbar Spinal Stenosis
Clinical Trial of Minimally Invasive Robotic Spine Surgery
The purpose of this study was to quantify potential short- and long-term benefits of robotically-guided minimally invasive spine surgery in instrumentation of degenerative lumbar or lumbosacral spine disease in adult patients, in…
- Trial name
- NCT02121249
- Testing
- Renaissance, Mazor Robotics Ltd, Caesare, Israel, free hand technique
- Where
- South Korea
- Volunteers
- 40 people
- Sponsor
- Seoul National University Hospital
Postoperative Pain
Oral Versus Intravenous Acetaminophen in Lumbar Spine Surgery
The goal of this study is to compare whether oral or intravenous acetaminophen works better for pain control in patients undergoing lumbar spine fusion surgery
- Trial name
- NCT07203079
- Testing
- Acetaminophen Oral Tablet, Acetaminophen infusion
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Stanford University
Spondylolisthesis, Intervertebral Disc Degeneration
Clinical Evidence of Robot Guided vs. Navigated vs. Free Hand Lumbar Spinal Fusion
Computer-based navigation systems were first introduced to spine surgery in 1995 and while they have been long established as standards in certain cranial procedures, they have not been similarly adopted in spine surgery.
- Trial name
- NCT02998060
- Testing
- Pedicle Screw Placement, SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel), 3D C-Arm (Ziehm Imaging, Nuremberg, Germany)
- Where
- 2 sites in Germany, Switzerland
- Sponsor
- Marc Schröder
Osteoporosis, Fusion of Spine, Lumbar Region
Effects of Denosumab on Bone Fusion in Osteoporotic Patients After Lumbar Fusion
Lumbar fusion is an accepted and effective technique for the treatment of lumbar degenerative disease. As the population ages, disability associated with spinal pathology and spinal surgery is rapidly increasing and there is a…
- Trial name
- NCT05203588
- Testing
- Denosumab 60 mg/ml Injectable Solution [Prolia], calcium and vitamin D
- Where
- China
- Volunteers
- 116 people
- Sponsor
- Shanghai Changzheng Hospital
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing…
- Trial name
- PARTNER (NCT04679896)
- Testing
- MagnetOs Putty
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Kuros Biosurgery AG
Intervertebral Disc Degeneration, Intervertebral Disc Displacement
Proprio Spine Measurement Tool
This study will prospectively collect data to evaluate the effectiveness of a novel intraoperative spinal measurement system to assist the surgeon with intraoperatively achieving pre-planned alignment-related parameters to the…
- Conditions
- Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Spinal Curvatures, Spinal Osteochondrosis
- Trial name
- NCT07023393
- Testing
- Intraoperative spinal measurement system
- Where
- United States
- Sponsor
- Duke University
Spine Surgery
"Efficacy of Hybrid Systems ("Topping Off") Versus Rigid Spinal Fusion in Lumbar Fusion Surgery: A Dual-center, Prospective, Randomized Pilot Study ("CD Horizon BalanC")"
Effectiveness of hybrid systems ("topping off") compared to rigid spondylodesis in fusion surgery of the lumbar spine: A prospective, randomized, bicentric pilot study ("CD HORIZON BalanC™)
- Trial name
- BalanC (NCT02551302)
- Testing
- Solera™ Medtronic, CD HORIZON BalanC™ Medtronic
- Volunteers
- 60 people
- Sponsor
- University of Cologne
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
Medium-/Long-segment Spinal Fusion Patients, Spine Surgeons
Evaluation of an Online Peri-operative Health Education Platform for Patients Undergoing Spine Surgery: Ready Set Recover
Chronic back pain is the world's leading cause of disability, with spine surgery being a common yet costly intervention. However, many patients experience suboptimal recovery, with persistent pain and functional limitations…
- Conditions
- Medium-/Long-segment Spinal Fusion Patients, Spine Surgeons, Chronic Low Back Pain, Scoliosis Patients
- Trial name
- NCT07766824
- Testing
- Ready Set Recover
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- National University of Natural Medicine
Fusion of Spine, Lumbar Region
Evaluation of Fusion After ALIF With an Osteoinductive Material or With Homologus Bone
The aim of this study was to determine whether instrumented anterior lumbar interbody Fusion with a new nanocrystalline hydroxyapatite embedded in a silica gel matrix (NH-SiO2) was associated with superior radiological and…
- Trial name
- NCT03331159
- Testing
- NanoBone, Homologous Bone
- Volunteers
- 20 people
- Sponsor
- Johann Wolfgang Goethe University Hospital
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
Spinal Stenosis Lumbar, Spondylolisthesis
Randomized Control Trial of Quadratus Lumborum Block for Lumbar Spine Decompression and Fusion Surgery
Lumbar spinal decompression and fusion is a commonly performed procedure fro neural impingement and back pain from a variety of pathologies.
- Conditions
- Spinal Stenosis Lumbar, Spondylolisthesis, Fusion of Spine, Lumbar Region, Degeneration Spine
- Trial name
- NCT04447950
- Testing
- Type 2/posterior Quadratus Lumborum block
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Assuta Medical Center
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG