Clinical trials: Lumbar Surgery
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
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
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.
Radiculopathy, Low Back Pain
Low Back Study to Compare Traditional Physical Therapy With Combined Therapy Protocol
The most common chronic low back pain conditions are a consequence of disc disease as well as muscular and bony etiologies. The discs degenerate and weaken, bulge and are pushed into the space containing the spinal cord or a…
- Trial name
- NCT01236092
- Testing
- conservative therapy - traction, vibration, exercise
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Michael Wilson & Associates Health Care Consulting, LLC
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
Lumbar Spine Degeneration
Study Using the SpinalStim Device Following Lumbar Fusion Surgery
This study examines the effect of adjunctive use of the SpinalStim bone growth stimulator on lumbar fusion rate in high risk subjects who have had lumbar fusion surgery.
- Trial name
- NCT03176303
- Testing
- SpinalStim
- Where
- United States
- Volunteers
- 206 people
- Sponsor
- Orthofix 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
Degenerative Disc Disease, Spondylolisthesis
Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from…
- Trial name
- NCT00798239
- Testing
- Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
- Where
- 5 sites in Canada
- Volunteers
- 24 people
- Sponsor
- BioSurface Engineering Technologies, Inc
Sacroiliac Joint Disruption, Scoliosis Lumbar Region
SI Joint Stabilization in Long Fusion to the Pelvis
The purpose of this study is to compare outcomes of subjects undergoing multilevel lumbar fusion (MLF) surgery with and without the iFuse 3-D implants in the "bedrock" trajectory.
- Trial name
- SILVIA (NCT04062630)
- Testing
- iFuse 3-D in Bedrock Configuration, Multilevel Lumbar Fusion surgery
- Where
- 31 sites in United States, Australia and 3 more
- Volunteers
- 213 people
- Sponsor
- SI-BONE, 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
Transforaminal Lumbar Interbody Fusion Surgery
The Objective of the Protocol is to Generate Real World Evidence (RWE) Supporting the Safety, Performance, and Health Economics of Using the Regulatory Approved and Commercially Available EARP Interbody System Used During Lumbar Interbody Fusion (LIF) Procedures With the EARP Nerve Cuff Electrode
The goal of the trial is to generate data to support the safety, performance, and cost effectiveness of using the EARP devices during Lumbar Interbody Fusion (LIF) procedures.
- Trial name
- EARP-2 (NCT07020000)
- Testing
- Device: Nerve Cuff and Retractor System
- Where
- 5 sites in United States
- Volunteers
- 120 people
- Sponsor
- Retropsoas Technologies, LLC
Spine Surgery
Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery
The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments.
- Trial name
- NCT05016739
- Testing
- CADISS
- Where
- Belgium
- Volunteers
- 21 people
- Sponsor
- AuXin Surgery SA
Degenerative Disc Disease, Spondylolisthesis
Pilot Study to Assess Safety/Preliminary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from…
- Trial name
- NCT00798902
- Testing
- Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
- Where
- 6 sites in United States
- Volunteers
- 22 people
- Sponsor
- BioSurface Engineering Technologies, Inc
Degenerative Disc Disease
Comparative Analysis of Virtuos and Autograft in Lumbar Fusion
Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental…
- Trial name
- NCT05614284
- Testing
- Virtuos
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Orthofix Inc.
Failed Back Surgery Syndrome
A Post Market Study on DRG Stimulation in FBSS (SYMPATHY)
The purpose of this Post Market Observational Study is to monitor the effect of the Axium® SCS System in the management of chronic pain following surgical lumbar discectomy in subjects whom are routinely scheduled for treatment…
- Trial name
- NCT02634398
- Where
- Switzerland
- Sponsor
- Abbott Medical Devices
Lumbar Spinal Stenosis
The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.
- Trial name
- NCT01067014
- Testing
- Baxano iO-Flex® System
- Where
- 18 sites in United States
- Volunteers
- 75 people
- Sponsor
- Baxano Surgical, 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
Degenerative Spondylolisthesis, Spinal Stenosis
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral…
- Trial name
- ENHANCE (NCT04483297)
- Testing
- AK1320 MS, Control
- Where
- 7 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Asahi Kasei Therapeutics Corporation
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