Clinical trials: Spine, Open
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.
Lumbar Degenerative Disc Disease
A Prospective Non-concurrent Controlled Evaluation of Open and MAS® PLIF
The study is a prospective non-concurrent controlled observational evaluation of short-term operative results. As such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10…
- Trial name
- NCT01640977
- Testing
- Open PLIF (posterior lumbar interbody fusion), MAS PLIF
- Where
- 4 sites in United States
- Volunteers
- 67 people
- Sponsor
- NuVasive
Osteoarthritis of the Lumbar Spine, Pain, Back
A Study to Evaluate the Efficacy and Safety of X0002 Spray in Subjects With Osteoarthritis of the Lumbar Spine
This is a Phase 3, Multicenter, Randomized, 22 Week, Double-Blind, Placebo Controlled and 3-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of Subjects with…
- Trial name
- NCT03110523
- Testing
- X0002
- Sponsor
- Techfields Pharma Co. Ltd
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
Spine Surgery
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of…
- Trial name
- NCT06827795
- Testing
- A burr used in spine surgery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Surgify Medical Oy
Spinal Surgery, Vascular Surgery
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
- Trial name
- NCT00491608
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- ZymoGenetics
Chronic Back Pain
SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
- Trial name
- NOVA (NCT04571242)
- Testing
- DTM Programming, Conventional SCS programming
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- SGX Nova LLC
Central Nervous System Diseases
Safety and Efficacy of MultiHance in Pediatric Patients
The purpose of this study was to assess the safety and enhancing properties of the magnetic resonance imaging (MRI) contrast agent MultiHance in children aged 2 to 17 years having central nervous system (CNS) disorders.
- Trial name
- NCT00323310
- Testing
- gadobenate dimeglumine
- Where
- United States
- Volunteers
- 92 people
- Sponsor
- Bracco Diagnostics, 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.
Neurogenic Bladder
Augmentation Cystoplasty Using an Autologous Neo-Bladder
Subjects with neurogenic bladder secondary to spina bifida refractory to medical treatment will be enrolled. The hypothesis is that augmentation cystoplasty using an autologous neo-bladder construct will significantly increase…
- Trial name
- NCT00419120
- Testing
- Autologous neo bladder construct
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Tengion
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
Neurogenic Detrusor Overactivity
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
- Trial name
- KANGUROO (NCT05491525)
- Testing
- Vibegron
- Where
- 38 sites in United States, Belgium and 14 more
- Volunteers
- 71 people
- Sponsor
- Urovant Sciences GmbH
Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft…
- Conditions
- Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- STABILITY (NCT06355791)
- Testing
- Minuteman G5 Device
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Spinal Simplicity LLC
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
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative…
- Trial name
- NCT02104167
- Testing
- ROIC interbody cage with VerteBRIDGE plating
- Where
- 7 sites in United States
- Volunteers
- 110 people
- Sponsor
- LDR Spine USA
Gait Impairment, Cerebral Palsy (CP)
Clinical Investigation to Validate the Safety and Performance of the ABLE Kids Device in Pediatric Patients With Neurological Gait Disorders in a Clinical Setting
The primary objective of the study is to validate the safety and clinical performance of the ABLE Kids device in pediatric patients with neurological gait disorders or muscular weakness during a 10-session gait training program…
- Conditions
- Gait Impairment, Cerebral Palsy (CP), Neuromuscular Diseases (NMD), Spinal Cord Injuries (SCI)
- Trial name
- NCT07745712
- Testing
- ABLE Kids
- Where
- Spain
- Volunteers
- 15 people
- Sponsor
- ABLE Human Motion S.L.
Anemia, Venous Thrombosis
A Study to Confirm the Safety and Efficacy of Epoetin Alfa (PROCRIT) Administered Perioperatively vs. the Standard of Care in Blood Conservation in Patients Undergoing Major Elective Spinal Surgery (SPINE Study)
This study is designed to investigate the incidence of deep vein thrombosis in patients receiving a perisurgical regimen of epoetin alfa (PROCRIT®) as compared to patients receiving standard of care blood conservation management.
- Trial name
- NCT00211146
- Testing
- epoetin alfa
- Volunteers
- 680 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Lumbar Disc Herniation, Degenerative Spinal Stenosis
CETIS-I (CEra Traction Improves Spine-I)
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and…
- Conditions
- Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
- Trial name
- NCT05549596
- Testing
- Ceragem Master V6 Traction, Physical therapy with standard traction device
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Ceragem Clinical Inc.
Cerebral Palsy (CP), Spastic Paraplegia
Retrospective Study on the WalkOn AFO in Children or Teenagers With Neurological Pathologies
The goal of this observational study is to assess the interest of prefabricated carbon fiber ankle foot orthoses (AFO) in children and teenagers with central or peripheral neurological pathologies.
- Conditions
- Cerebral Palsy (CP), Spastic Paraplegia, Spinal Cord Injuries (SCI), Spina Bifida
- Trial name
- NCT06740006
- Where
- France
- Volunteers
- 65 people
- Sponsor
- Otto Bock France SNC
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