Clinical trials: Lumbar Spinal Fusion Surgery
Spine Disease, Spinal Fusion
Validity and Accuracy of a Machine Learning Predictive Model in the Exploitation of Patients Related Outcomes in Spine Surgery
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green…
- Conditions
- Spine Disease, Spinal Fusion, Surgery, Spine Degeneration
- Trial name
- DeepSurgery (NCT05166018)
- Testing
- SuMO Patient
- Where
- 2 sites in France
- Volunteers
- 174 people
- Sponsor
- Cortexx Medical Intelligence
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 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.
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
Spinal Disease
A Feasibility Study to Evaluate the TURRIS Facet Fusion System in Lumbar Spinal Surgery
This is a prospective, exploratory study to verify intra-operative handling and safety and to collect preliminary short-term safety and efficacy data of the Turris® Facet Fuser, a small bioresorbable device for the immediate…
- Trial name
- NCT02294669
- Testing
- Turris Facet Fuser
- Where
- 2 sites in Switzerland
- Volunteers
- 3 people
- Sponsor
- SpineWelding AG
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
Low Back Pain, Spondylolisthesis
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
Lumbar spinal fusion is commonly performed as a "last resort" in patients with chronic low back pain caused by degenerative changes and instability of the spine.
- Conditions
- Low Back Pain, Spondylolisthesis, Spinal Stenosis, Intervertebral Disc Displacement
- Trial name
- NCT00095095
- Testing
- Lumbar Interbody Fusion
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 102 people
- Sponsor
- Medtronic Spinal and Biologics
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 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
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.
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
Intervertebral Disc Degeneration
Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery
The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).
- Trial name
- Intebody (NCT02400762)
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- ISTO Technologies, Inc.
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.
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
Degenerative Disc Disease
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements.
- Trial name
- APPRAISET2 (NCT01018771)
- Testing
- Actifuse ABX, INFUSE, plus Mastergraft granules
- Where
- Australia
- Volunteers
- 100 people
- Sponsor
- Baxter Healthcare Corporation
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 Spine Stenosis, Lumbar Spine Degeneration
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research.
- Trial name
- NCT05452694
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- OpalGenix, Inc
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
Spine Fusion, Spinal Deformity
Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of…
- Trial name
- NCT05001893
- Testing
- S53P4 bioactive glass putty
- Where
- Finland
- Volunteers
- 500 people
- Sponsor
- Bonalive Biomaterials Ltd
Degenerative Disc Disease
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the…
- Trial name
- NCT00215319
- Testing
- Lumbar I/F with cage and pedicle screws
- Where
- 2 sites in United States
- Volunteers
- 139 people
- Sponsor
- DePuy Spine