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
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
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
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.
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
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.
Failed Back Surgery Syndrome, Back Pain
Spinal Cord Stimulation for Predominant Low Back Pain
The purpose of this study is to compare the effectiveness of spinal cord stimulation (SCS) using the Medtronic Specify® 5-6-5 multicolumn surgical lead plus optimal medical management (OMM) versus OMM alone in patients suffering…
- Conditions
- Failed Back Surgery Syndrome, Back Pain, Pain in Leg, Unspecified
- Trial name
- PROMISE (NCT01697358)
- Testing
- Spinal Cord Stimulation (SCS), Optimal Medical Management (OMM)
- Where
- 28 sites in United States, Belgium and 7 more
- Volunteers
- 278 people
- Sponsor
- MedtronicNeuro
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
Chronic Pain, Pain, Intractable
An Implantable Spinal Cord Stimulation Pain Management System
There are many treatment options available for the management of chronic pain . Some include, but are not limited to, over-the-counter medications, Non-Steroidal Anti-Inflammatory Drugs, Physical Therapy, Transcutaneous…
- Conditions
- Chronic Pain, Pain, Intractable, Pain, Back Pain
- Trial name
- NCT00205855
- Testing
- Precision SCS
- Where
- 9 sites in United States
- Volunteers
- 65 people
- Sponsor
- Boston Scientific Corporation
Spinal Injuries, Adhesions
DuraGen Plus® Adhesion Barrier for Use in Spinal Surgery
To evaluate the safety and effectiveness of DuraGen Plus® Adhesion Barrier Matrix as an adhesion barrier in spinal surgery to reduce the extent of peridural fibrosis formation and radicular pain in comparison to a control group…
- Trial name
- NCT00387829
- Testing
- DuraGen Plus Adhesion Barrier Matrix
- Where
- 36 sites in United States
- Volunteers
- 347 people
- Sponsor
- Integra LifeSciences Corporation
Lumbar Spinal Stenosis
The Vertos MILD™ Preliminary Patient Evaluation Study
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for…
- Trial name
- NCT00749073
- Testing
- Minimally Invasive Lumbar Decompression (MILD™)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Vertos Medical, Inc.
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
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
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Failed Back Surgery Syndrome
Spinal Cord Stimulation Frequency Study
The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).
- Trial name
- NCT01750229
- Testing
- 1200 Hz, 3030 Hz, 5882 Hz
- Where
- United Kingdom
- Volunteers
- 53 people
- Sponsor
- MedtronicNeuro
Pain
Compare the Efficacy and Safety of Norspan to Tramadol/Acetaminophen With Prolonged Postoperative Pain (PASSION)
The purpose of this study is to compare the efficacy and safety of buprenorphine transdermal system to tramadol/acetaminophen.
- Trial name
- NCT01983111
- Testing
- buprenorphine, tramadol/acetaminophen
- Where
- South Korea
- Volunteers
- 136 people
- Sponsor
- Mundipharma Korea Ltd
Lumbar Spinal Stenosis
MiDAS I (Mild® Decompression Alternative to Open Surgery): Vertos Mild Patient Evaluation Study
This is a multi-center, prospective, clinical study to assess the clinical application and outcomes of MILD® Interlaminar Decompression in patients with symptomatic lumbar spinal stenosis.
- Trial name
- MiDAS I (NCT00956631)
- Testing
- Interlaminar Decompression
- Where
- 13 sites in United States
- Volunteers
- 78 people
- Sponsor
- Vertos Medical, Inc.
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation