Clinical trials: Spondylosis
Degenerative Disc Disease, Spondylolisthesis, Grade 1
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
- Trial name
- APROPOS (NCT02704689)
- Testing
- AccuLIF expandable TLIF cage
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- VB Spine, LLC
Herniated Disc, Radiculopathy
Slotted Hole Versus Fixed Hole C-Tek
The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.
- Conditions
- Herniated Disc, Radiculopathy, Spondylolysis
- Trial name
- NCT00585923
- Testing
- Fixed hole C-Tek™ Plate, Slotted hole C-Tek™ Plate
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Zimmer Biomet
Lumbar Spinal Stenosis, Spondylolisthesis
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple…
- Trial name
- SPSI (NCT03754972)
- Testing
- Sagittal plane shear index (SPSI)
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Medical Metrics Diagnostics, Inc
Idiopathic Scoliosis, Spondylolisthesis
Low Dose Ketamine Study on Opioid Tolerance and Hyperalgesia
The purpose of this study is to: 1. Establish whether ketamine can decrease opioid consumption and modulate the onset of opioid tolerance and prevent opioid-induced hyperalgesia in pediatric subjects, ages 10 years to 18 years…
- Trial name
- KPSF (NCT01325493)
- Testing
- Ketamine, Normal Saline
- Where
- United States
- Volunteers
- 54 people
- Sponsor
- Julia Finkel
Lumbar Osteoarthritis, Spondylosis
Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively.
- Conditions
- Lumbar Osteoarthritis, Spondylosis, Lumbar Disc Disease, Spinal Stenosis
- Trial name
- NCT02700451
- Testing
- Ketorolac, Acetaminophen
- Where
- United States
- Volunteers
- 178 people
- Sponsor
- Hospital for Special Surgery, New York
Lumbar Spondylolisthesis, Degenerative Disc Disease
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively…
- Conditions
- Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy
- Trial name
- ViviGen (NCT03733626)
- Testing
- ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system, Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
Spondylolisthesis, Neurologic Deficits
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Trial name
- DSS (NCT01461005)
- Testing
- Dynamic Stabilization System (DSS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Paradigm Spine
Cervical Radiculopathy, Cervical Spondylosis
Effectiveness of Cervical Transforaminal Epidural Steroid Injection
Study Purpose: This study is intended to monitor outcomes for 1 year following cervical TFESI. Based on current clinic volume and enrollment rates into a current study of cervical epidural injections that is nearing completion…
- Conditions
- Cervical Radiculopathy, Cervical Spondylosis, Disk, Herniated
- Trial name
- NCT04544683
- Testing
- Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- University of Utah
Degenerative Spondylolisthesis, Pseudoarthrosis
Dynesys Spinal System Post Market 522 Study
The purpose of this study is to assess the safety and fusion rates following posterior lateral fusion with the Dynesys Spinal System used as an adjunct to fusion and compare to literature control.
- Trial name
- NCT01528072
- Testing
- Dynesys Spinal System
- Where
- 9 sites in United States
- Volunteers
- 153 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Trauma (Including Fractures)
BIO4 Clinical Case Study: Cervical Spine
The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.
- Conditions
- Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
- Trial name
- NCT03077204
- Testing
- 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Aviator Anterior Cervical Plating System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seton Healthcare Family
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results…
- Trial name
- RAVINE (NCT02068729)
- Volunteers
- 131 people
- Sponsor
- K2M, Inc.
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.
Myelopathy Cervical, Kyphosis Post Surgical
Comparison Between C3-6 Laminoplasty and C3 Laminectomy With Cervical Laminoplasty
Investigators performed a prospective randomized controlled trial for comparing postoperative clinical and radiological outcomes between C3 laminectomy with laminoplasty and C3-6 laminoplasty.
- Conditions
- Myelopathy Cervical, Kyphosis Post Surgical, Neck Pain, Ossification of Posterior Longitudinal Ligament
- Trial name
- NCT05006495
- Testing
- C3 laminectomy, C3 laminoplasty
- Where
- South Korea
- Volunteers
- 126 people
- Sponsor
- Seoul National University Hospital
Juvenile; Scoliosis, Scoliosis Idiopathic
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery.
- Conditions
- Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital
- Trial name
- SurgeryPal (NCT04637802)
- Testing
- CBT (SurgeryPal), Education
- Where
- United States
- Volunteers
- 433 people
- Sponsor
- Seattle Children's Hospital
Spinal Stenosis, Lumbar Region, Spondylolisthesis
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults.
- Trial name
- NCT03968965
- Testing
- 3D MvIGS Spine Navigation, 2D Fluoroscopy
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- 7D Surgical Inc.
Diabetes, Cervical Myelopathy
Diabetes and Glycosylation in Cervical Spondylosis
The purpose of this study is to determine the relevant significance of diabetes on cervical disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile in patients undergoing anterior cervical…
- Conditions
- Diabetes, Cervical Myelopathy, Cervical Spondylosis
- Trial name
- NCT02758899
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Washington University School of Medicine
Degenerative Disc Disease, Spondylolisthesis, Grade 1
Safety and Efficacy of the CarboClear Pedicle Screw System
The purpose of this trial is to demonstrate the safety and effectiveness of the CarboClear Pedicle Screw System, for skeletally mature DDD patients undergoing one level spinal fusion in combination with interbody fusion device…
- Trial name
- NCT02626624
- Testing
- Implantation of the CarboClear Pedicle Screw System
- Where
- 8 sites in United States, Israel
- Volunteers
- 57 people
- Sponsor
- CarboFix Orthopedics Ltd.
Degenerative Changes, Stenosis
Accell Evo3™ Demineralized Bone Matrix 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 posterolateral spine fusion, as compared to local autograft.
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT02018445
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- SeaSpine, Inc.