Clinical trials: Spinal Surgery
Pain, Intractable
OPTIONS Spinal Cord Stimulation Programming Parameters
The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
- Trial name
- NCT02503787
- Testing
- Spinal Cord Stimulation (SCS)
- Where
- 11 sites in United States
- Volunteers
- 64 people
- Sponsor
- MedtronicNeuro
Degenerative Disc Disease
Trinity Elite in Lumbar Fusion
This prospective, post-market, open label clinical study is designed to examine the lumbar fusion rate at 24 months post operative in subjects who have undergone a lumbar fusion surgery using Trinity Elite with or without local…
- Trial name
- NCT02969616
- Testing
- Trinity Elite
- Volunteers
- 300 people
- Sponsor
- Orthofix Inc.
Lumbar Spinal Stenosis
The STEPS - Totalis™ Trial
The purpose of this study is to determine safety and effectiveness, as measured by changes in pain, disability, patient satisfaction, and claudicatory symptoms, at 6 months following treatment with the Totalis™ Direct…
- Trial name
- NCT02079038
- Testing
- Totalis, Comparator Surgical Procedure
- Where
- 19 sites in United States
- Volunteers
- 180 people
- Sponsor
- VertiFlex, Incorporated
Pain, Chronic, Pain, Intractable
Spinal Cord Stimulation in the Treatment of Chronic, Intractable Pain Using the Nalu™ Neurostimulation System
The Nalu Neurostimulation System is capable of delivering multiple therapy options to address patient needs. The study will confirm the efficacy, safety, comfort and compliance with the Nalu Neurostimulation System in adult…
- Conditions
- Pain, Chronic, Pain, Intractable, Pain, Back
- Trial name
- nPower™-US (NCT04503109)
- Testing
- Nalu Neurostimulation System
- Where
- 8 sites in United States
- Volunteers
- 110 people
- Sponsor
- Nalu Medical, Inc.
Lumbar Spinal Stenosis
MiDAS II (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, patient outcomes assessment of Minimally Invasive Lumbar Decompression with the Mild® devices in patients with symptomatic central canal spinal stenosis.
- Trial name
- NCT01082159
- Testing
- lumbar decompression
- Where
- 8 sites in United States
- Volunteers
- 55 people
- Sponsor
- Vertos Medical, Inc.
Degenerative Disc Disease
Study of an Expandable Interbody Device for the Lumbar Spine
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease.
- Trial name
- CALIBER (NCT02075554)
- Testing
- CALIBER
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Globus Medical Inc
Scarring, Spinal Stenosis
dHACM in Lumbar Decompression and Microdiscectomy Surgery
Prospective evaluation of the safety and efficacy of dHACM on clinical outcomes in lumbar laminectomy and microdiscectomy patients as assessed by Oswestry Disability Index.
- Conditions
- Scarring, Spinal Stenosis, Herniated Disc
- Trial name
- NCT02300909
- Testing
- Lumbar Decompression Surgery, Microdiscectomy Surgery, Dehydrated Human Amnion/Chorion Membrane (dHACM)
- Where
- United States
- Volunteers
- 143 people
- Sponsor
- MiMedx Group, Inc.
Lumbar Spinal Stenosis
MiDAS III (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, observational clinical study to compare patient outcomes following treatment with either the mild® procedure or epidural steroid injection in patients with moderate to severe lumbar spinal…
- Trial name
- MiDAS III (NCT01315145)
- Testing
- Percutaneous Lumbar Decompression, Epidural Steroid Injection
- Where
- 27 sites in United States
- Volunteers
- 138 people
- Sponsor
- Vertos Medical, Inc.
Meningioma, Tumor, Brain
MiDura-Study (Neuro-Patch in Duraplasty)
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer
- Conditions
- Meningioma, Tumor, Brain, Chiari Malformation, Vascular Malformation
- Trial name
- MiDura (NCT04189172)
- Where
- 4 sites in France, Germany
- Volunteers
- 328 people
- Sponsor
- Aesculap AG
Failed Back Surgery Syndrome, Complex Regional Pain Syndrome (CRPS)
A Study to Confirm the Safety of High Frequency DRG Stimulator in Patients With Chronic Lower Limb Pain
This study is a prospective, single-arm, open label, single center pilot study to confirm the safety of a ultrahigh frequency DRG stimulator in patients with chronic lower limb pain. The actual trial length is 5 days.
- Trial name
- NCT03285113
- Testing
- GiMer Medical MN 1000 External Stimulator
- Where
- Taiwan
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- GiMer Medical
Scoliosis
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
It is current practice for children who have surgery for early onset scoliosis (EOS) to be treated with insertion of extendable implants known as growth rod systems.
- Trial name
- NCT01362881
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Ellipse Technologies, Inc.
Spinal Fusion
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.
- Trial name
- NCT03425799
- Testing
- Sodium Chloride 0.9% Inj, Tranexamic Acid
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Exela Pharma Sciences, LLC.
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
Lumbar Spinal Stenosis, Spondylolisthesis
Minuteman Spinal Fusion Implant Versus Surgical Decompression for Lumbar Spinal Stenosis
Lumbar spinal stenosis (LSS), is a common disorder of narrowing of the spinal canal in the lower part of the back. This causes discomfort in the legs when standing or walking because of pressure on the spinal nerves.There are…
- Conditions
- Lumbar Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT01455805
- Testing
- Minuteman Fusion Implant, surgical decompression
- Where
- 4 sites in United Kingdom
- Volunteers
- 48 people
- Sponsor
- Spinal Simplicity LLC
Psychological Stress, Cardiopulmonary Bypass Surgery
CARINAE for Stress Relief in Perioperative Care
Preventing pre-surgical stress can help patients achieve positive outcomes on health and well-being. However, very few patients receive adequate stress relief support prior to a surgical procedure.
- Conditions
- Psychological Stress, Cardiopulmonary Bypass Surgery, Coronary Artery Bypass Surgery, Cardiac Valve Replacement
- Trial name
- CARINAE (NCT05184725)
- Testing
- SaMD CARINAE
- Where
- 5 sites in Italy, Netherlands and 1 more
- Volunteers
- 50 people
- Sponsor
- Adhera Health, Inc.
Lumbar Disc Herniation
Post-marketing Clinical Follow-up of the Medical Device DIVA®
Observational, ambispective, longitudinal, comparative, open, multicentric study. The main objective is to compare the performance of care in patients operated with and without DIVA®.
- Trial name
- NCT05277818
- Testing
- Surgery lumbar disc herniation
- Where
- France
- Volunteers
- 822 people
- Sponsor
- SC Medica
SPINAL Fracture, Vertebral Fractures
Clinical Study With a Robotic Assistant in Patients Requiring a Spinal Transpedicular Fixation
This multicenter, non-comparative clinical trial, led by two principal investigators in Spain, aims to evaluate the safety and performance of a robotic assistant, based on a electromechanical tracking system, in patients…
- Conditions
- SPINAL Fracture, Vertebral Fractures, Spinal Stenosis, Kyphosis
- Trial name
- NCT06153511
- Testing
- Robot assisted spinal transpedicular fixation
- Where
- Spain
- Volunteers
- 13 people
- Sponsor
- Cyber Surgery S.L.
Degenerative Spine Disease, Spinal Deformity
Prospective, Observational Registry of Renaissance-guided Spine Surgeries
To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
- Trial name
- NCT02212899
- Where
- 4 sites in United States
- Volunteers
- 93 people
- Sponsor
- Mazor Robotics
Idiopathic Scoliosis, Spinal Curvatures
UNiD Rods Register
Retro-prospective study allowing inclusion of patients with spinal deformities treated by patient-specific rods (UNiD). This study aims to assess performance, clinical outcomes and safety
- Conditions
- Idiopathic Scoliosis, Spinal Curvatures, Spondylolisthesis, Degenerative Scoliosis
- Trial name
- NCT02926404
- Testing
- UNiD Rods
- Where
- 13 sites in Belgium, France and 1 more
- Volunteers
- 743 people
- Sponsor
- Medicrea International
Spine Surgery
Comprehensive Spinal Alignment Planning Study
A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied.
- Trial name
- NCT02606695
- Testing
- NuvaMap O.R., NuvaMap
- Where
- 15 sites in United States
- Volunteers
- 306 people
- Sponsor
- NuVasive