Clinical trials: Lumbar Surgery
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
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
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
Pain, Intractable, Pain, Chronic
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic…
- Trial name
- NCT06442410
- Testing
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Where
- 12 sites in Belgium, Germany and 2 more
- Volunteers
- 115 people
- Sponsor
- MedtronicNeuro
Back Pain
Spinal Cord Stimulation for Chronic and Intractable Back Pain
The purpose of this study is to evaluate the efficacy of spinal cord stimulation (SCS) using the Precision implantable neurostimulation device for chronic and intractable back pain in subjects who are not candidates for surgery…
- Trial name
- NCT00370695
- Testing
- Precision Spinal Cord Stimulation System
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Scientific Corporation
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.
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.
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 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.
Lumbar Surgery
Study of PEMF (Pulsed Electromagnetic Field) Therapy in the Treatment of Persistent Post-Operative Pain Following Lumbar Surgery
To demonstrate the analgesic effectiveness of 2 modalities of PEMF treatment compared to sham treatment in patients with persistent pain following lumbar surgery when treatment is administered twice daily over a 60 day period.
- Trial name
- NCT02416973
- Testing
- Provant
- Where
- 8 sites in United States
- Volunteers
- 41 people, healthy volunteers welcome
- Sponsor
- Regenesis Biomedical, 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
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.
Postoperative Pain Management
Phase 4, Controlled Study in Adult Subjects Undergoing Primary, 1-2 Level, Open Lumbar Spinal Fusion Surgery
Primary Objective: The primary objective of this study is to compare postsurgical pain control following local infiltration analgesia (LIA) with EXPAREL admixed with bupivacaine HCl versus LIA with bupivacaine HCl in adult…
- Trial name
- NCT03015961
- Testing
- EXPAREL and bupivacaine HCl, Bupivacaine HCl
- Where
- 15 sites in United States
- Volunteers
- 38 people
- Sponsor
- Pacira Pharmaceuticals, Inc
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
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
A Post Market Study on Dorsal Root Ganglion (DRG) Stimulation in Failed Back Surgery Syndrome (FBSS)
18-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic pain following lumbar discectomy (Failed Back…
- Trial name
- SYMPATHY (NCT02335216)
- Testing
- Implantation with the commercially available Axium neurostimulator
- Where
- Netherlands
- Volunteers
- 22 people
- Sponsor
- Abbott Medical Devices
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.