Clinical trials: Spine
Central Nervous System Diseases
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.
- Trial name
- NCT00395460
- Testing
- Gadobutrol (Gadavist, Gadovist, BAY86-4875), Magnevist
- Where
- 4 sites in China
- Volunteers
- 147 people
- Sponsor
- Bayer
Degenerative Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF…
- Trial name
- MASTERS-D (NCT01143324)
- Testing
- MAST™ procedure
- Where
- 19 sites in Austria, Belgium and 12 more
- Volunteers
- 255 people
- Sponsor
- Medtronic Spinal and Biologics
Osteoporosis
Comparison of Teriparatide With Alendronate for Treating Glucocorticoid-Induced Osteoporosis
Osteoporosis is a condition in which the amount of bone is reduced, the bones are weak, and there is an increased risk for fractures.
- Trial name
- NCT00051558
- Testing
- Teriparatide, Alendronate Sodium
- Where
- 15 sites in United States, Austria and 4 more
- Volunteers
- 428 people
- Sponsor
- Eli Lilly and Company
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Vertebral Metastasis
Spinery® A Novel Radio-Frequency Tumor Ablation Device for Spine Metastatic Tumors
The SPARTA study (Spinery® Radiofrequency Ablation Device Study) is a prospective, multicenter, single-arm clinical investigation designed to evaluate the safety, performance, and efficacy of the Spinery® RF Generator and its…
- Trial name
- SPARTA (NCT05467540)
- Testing
- Spinery System
- Where
- 5 sites in Italy
- Volunteers
- 52 people
- Sponsor
- Axon srl
Metastatic Lesions in Vertebral Bodies
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following…
- Trial name
- STARRT (NCT02225223)
- Testing
- STAR™ Tumor Ablation System, StabiliT® Vertebral Augmentation System
- Where
- 14 sites in United States
- Volunteers
- 35 people
- Sponsor
- Merit Medical Systems, Inc.
Low Bone Mass, Low Bone Mineral Density
Study to Compare the Efficacy and Safety of DenosumAb Versus Placebo in Males With Osteoporosis
The purpose of this study is to assess how effective and safe denosumab is in a population of males with low bone mass at risk of fracture.
- Conditions
- Low Bone Mass, Low Bone Mineral Density, Males With Osteoporosis, Osteopenia
- Trial name
- NCT00980174
- Testing
- 60 mg denosumab
- Volunteers
- 242 people
- Sponsor
- Amgen
Osteoporosis, Osteoporosis, Age-Related
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis
- Trial name
- NCT03512262
- Testing
- Abaloparatide
- Where
- 34 sites in United States, Italy and 1 more
- Volunteers
- 228 people
- Sponsor
- Radius Health, Inc.
Surgery
Device to Reduce Surgery Site Contamination - Spine
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.
- Trial name
- NCT01262105
- Testing
- Air Barrier System Device
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Nimbic Systems, LLC
Cervical Degenerative Disc Disease, Radiculopathy
An Investigation of the Metal Concentration in Patients Implanted With the PRESTIGE LP™ Cervical Disc at Two Contiguous Levels in the Cervical Spine
This clinical study will assess the metal concentrations present in the blood serum of patients who receive surgical treatment with the PRESTIGE LP™ Cervical Disc at two contiguous cervical levels from C3-C7.
- Conditions
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- Trial name
- NCT03062657
- Testing
- PRESTIGE LP™ Cervical Disc
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medtronic Spinal and Biologics
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
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.
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.
Degenerative Spinal Disease, Deformity of Spine
Fenestrated Screw Study
The primary objective of this post-market study is to demonstrate that Oswestry disability index (ODI) score improved significantly at 12 months post-operatively as compared to baseline for each indication (degenerative spinal…
- Trial name
- FNS (NCT03797144)
- Testing
- CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement
- Where
- 6 sites in Belgium, Finland and 3 more
- Volunteers
- 27 people
- Sponsor
- Medtronic Spinal and Biologics
Osteoporosis
Transition From Alendronate to Romosozumab (AMG 785)
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated…
- Trial name
- NCT01588509
- Testing
- Romosozumab
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Amgen
Cancer, Spinal Fractures
CAFE Study - Cancer Patient Fracture Evaluation
The primary objective of this study is to evaluate the safety and effectiveness of balloon kyphoplasty treatment for painful, acute, vertebral compression fractures (VCFs) as compared to standard non-surgical therapy in patients…
- Trial name
- CAFE (NCT00211237)
- Testing
- Balloon Kyphoplasty, Non Surgical Management
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 134 people
- Sponsor
- Medtronic Spine LLC
Cervical Degenerative Disc Disease, Radiculopathy
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical…
- Conditions
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- Trial name
- NCT00637156
- Testing
- PRESTIGE LP device at two adjacent levels, Bi-level fusion with ATLANTIS Cervical Plate System
- Where
- 29 sites in United States
- Volunteers
- 397 people
- Sponsor
- Medtronic Spinal and Biologics
Metastasis Spine, Metastasis to Bone
OsteoCool Tumor Ablation Post-Market Study
This study evaluates the effectiveness of the Medtronic OsteoCool™ RF Ablation System.
- Trial name
- OPuS One (NCT03249584)
- Testing
- OsteoCool™ RF Ablation
- Where
- 16 sites in United States, Canada and 3 more
- Volunteers
- 218 people
- Sponsor
- MedtronicNeuro
Degenerative Disc Disease
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease…
- Trial name
- NCT02068768
- Testing
- Avenue® L Interbody Fusion System (LDR Spine)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- LDR Spine USA
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