Clinical trials: Lumbar Spine Surgery
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
Lumbar Disc Herniation
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy
This study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. Clinical parameters as well as health economy will be assessed.
- Trial name
- TESCORT (NCT01622413)
- Testing
- joimax TESSYS, Microdiscectomy
- Where
- 3 sites in Austria, Germany
- Sponsor
- Joimax GmbH
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.
Transforaminal Lumbar Interbody Fusion Surgery
A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.
The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery.
- Trial name
- NCT06204900
- Testing
- Nerve Cuff and Retractor System
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Retropsoas Technologies, LLC
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.
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
Lumbar Spinal Stenosis, Lumbar Disc Herniation
Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery
This multicenter, randomized, subject- and evaluator-blinded, active-controlled, non-inferiority clinical trial was conducted to evaluate the efficacy and safety of Collabarrier®, a collagen-based adhesion barrier, compared to…
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Epidural Fibrosis, Postoperative Adhesion
- Trial name
- NCT07153822
- Testing
- Collagen-based adhesion barrier, Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier
- Where
- 6 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- DALIM TISSEN Co., Ltd.
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.
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
Intraoperative Monitoring, Spinal Diseases
Intraoperative Monitoring (IOM) Patient Registry
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the…
- Trial name
- IOM (NCT02187653)
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- DC2 Healthcare
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
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
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
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
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
Chronic Low Back Pain, Lumbar Degenerative Disc Disease
Safety and Performance Study of the CAdiscTM-L Lumbar Spinal Disc Replacement Device For CE Marking
The purpose of this European Union (EU) study to evaluate the safety and performance of the CAdiscTM-L Lumbar Spinal Disc Replacement Device in the surgical replacement of the lumbar intervertebral discs (L3 to S1) for patients…
- Trial name
- DISCERN (NCT00949936)
- Testing
- CAdisc™-L (Total Disc Replacement)
- Where
- 4 sites in Belgium, Germany and 2 more
- Sponsor
- Ranier Technology Limited
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
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.
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