Clinical trials: Spinal Instability
Degenerative Spondylolisthesis or Retrolisthesis, Spinal Stenosis
A Clinical Study of the Dynesys(R) Spinal System
This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.
- Conditions
- Degenerative Spondylolisthesis or Retrolisthesis, Spinal Stenosis, Stenosing Lesion.
- Trial name
- NCT00759057
- Testing
- Posterior Pedicle Screw System
- Where
- 26 sites in United States
- Volunteers
- 399 people
- Sponsor
- Zimmer Biomet
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- PROTONTO (NCT04542577)
- Where
- 2 sites in Germany
- Volunteers
- 208 people
- Sponsor
- Aesculap AG
Degenerative Disc Disease, Spondylolisthesis
Quintex® Follow-up After One Year Minimum
Prospective study, not randomised, non-interventional, monocentric, investigating an intended patient cohort of 60 patients already operated on the cervical spine due to degenerative disc disease of the cervical spine down to the…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Trauma, Spinal Stenosis
- Trial name
- Quintex (NCT04489394)
- Where
- Germany
- Volunteers
- 60 people
- Sponsor
- Aesculap AG
Spinal Stenosis Occipito-Atlanto-Axial, Spinal Disease
Streamline Occipito-Cervico-Thoracic System Post-Market Clinical Follow-up
This is a multi-center, post-market, retrospective study design to collect safety and performance data for patients implanted with the Streamline OCT System.
- Conditions
- Spinal Stenosis Occipito-Atlanto-Axial, Spinal Disease, Spinal Stenosis Cervical, Spinal Stenosis Cervicothoracic Region
- Trial name
- OCT PMCF (NCT04171544)
- Testing
- Streamline Occipito-Cervico-Thoracic Spinal Fixation System
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- RTI Surgical
Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy
- Trial name
- NCT06320899
- Testing
- SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium, SpineShape System IV straight rod stiff
- Where
- 2 sites in Switzerland
- Volunteers
- 126 people
- Sponsor
- SpineSave AG
Degenerative Disc Disease, Spinal Stenosis
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT00762723
- Testing
- Trinica Anterior Lumbar Plate System
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Zimmer Biomet
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
Chronic Low-back Pain, Degenerative Disc Disease
Postmarket Clinical Follow-Up Study on Arcadius XP L® Interbody Fusion Device
The purpose of this study is to collect clinical and radiological mid-term (min. 1 year) data on the ArcadiusXP L® lumbar stand-alone cage in a post-market clinical follow-up study (PMCF) limited to 60 patients.
- Conditions
- Chronic Low-back Pain, Degenerative Disc Disease, Spondylolysis Lumbar, Postdiscectomy Syndrome
- Trial name
- ARREST (NCT05944081)
- Testing
- ArcadiusXP L® Interbody Fusion System
- Where
- 3 sites in Germany
- Sponsor
- Aesculap AG
Spondylolisthesis, Stenosis
CopiOs Posterolateral Fusion Procedure
To compare radiographic data collection from patients undergoing instrumented PLF with CopiOs(R) BVF or instrumented PLF with autologous bone and to assess overall clinical outcomes. Patients will serve as self controls.
- Trial name
- NCT01123850
- Testing
- Copios
- Where
- 6 sites in United States
- Volunteers
- 45 people
- Sponsor
- Zimmer Biomet
Degenerative Instability, Spondylolisthesis
PMCF Study on the Safety and Performance of CESPACE 3D
Prospective, pure data collection of all CeSPACE 3D patients in selected centers (not interventional, multicenter)
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instabilities
- Trial name
- CATALINA (NCT04477447)
- Where
- 2 sites in Germany
- Volunteers
- 101 people
- Sponsor
- Aesculap AG
Sacroiliac; Fusion, Sacroiliac
Prospective SPINE Registry
This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.
- Conditions
- Sacroiliac; Fusion, Sacroiliac, Joint Diseases, Musculoskeletal Diseases
- Trial name
- SPINE (NCT04176562)
- Testing
- RTI Spine products
- Where
- 12 sites in United States, Germany and 1 more
- Volunteers
- 5,000 people
- Sponsor
- Xtant Medical
Intervertebral Disc Degeneration, Stenosis, Spinal
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk…
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity
- Trial name
- NCT05648474
- Testing
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alphatec Spine, Inc.
Degenerative Instability, Spondylolisthesis
Confirmatory Investigation to Evaluate the Performance and Safety of ReSpace TiCell Cage Implants in TLIF
The primary objective of this study is to confirm superiority for the efficacy of the ReSpace Ticell Cage implants in Transforaminal Lumbar Interbody Fusion compared to state-of-the-art.
- Conditions
- Degenerative Instability, Spondylolisthesis, Post-discectomy Syndrome, Post-traumatic Instability
- Trial name
- NCT06265038
- Testing
- ReSpace TiCell Cage
- Where
- Hungary
- Volunteers
- 99 people
- Sponsor
- Sanatmetal Orthopaedic and Traumatologic Equipment Manufacturer Ltd.
Spinal Cord Injuries, Blood Pressure Disorders
ARC-IM System to Manage Symptomatic Blood Pressure Instability Secondary to Chronic Spinal Cord Injury
Empower BP is a pivotal, interventional, multicenter, prospective, randomized, controlled double-blinded study to evaluate the safety and effectiveness of the ARC-IM System in managing symptomatic blood pressure instability in…
- Trial name
- Empower BP (NCT07147296)
- Testing
- ARC-IM System Implantation, ARC-IM Therapy (Group 1), ARC-IM Therapy (Group 2)
- Where
- 13 sites in United States, Canada
- Volunteers
- 60 people
- Sponsor
- ONWARD Medical, Inc.
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Cervical Spinal Instability
Cervical Interbody Implant Study
The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).
- Trial name
- NCT04689854
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive
Spine Fracture, Degenerative Disc Disease
Post-Market Clinical Follow-Up Study on the Safety and Performance of Ennovate® Cervical
Multicenter Post market clinical follow-up Study on the Safety and Performance of Ennovate® Cervical - Prospective, pure data collection of all Ennovate Cervical patients in Total Indications
- Conditions
- Spine Fracture, Degenerative Disc Disease, Spinal Instability, Spinal Tumor
- Trial name
- CERISE (NCT05296889)
- Testing
- posterior stabilization for the cervical spine
- Where
- 4 sites in Germany
- Volunteers
- 200 people
- Sponsor
- Aesculap AG
Lumbar Spine Disease, Lumbar Spondylolisthesis
OSTEOAMP Lumbar Fusion Intra-Patient Controlled Study
The objective of this clinical study is to compare OSTEOAMP SELECT Fibers to Infuse Bone Graft, in terms of effectiveness and safety, when used as a bone graft substitute in in skeletally mature patients qualified for 2-lumbar…
- Conditions
- Lumbar Spine Disease, Lumbar Spondylolisthesis, Lumbar Spine Instability, Lumbar Spondylosis
- Trial name
- SELECT (NCT05405374)
- Testing
- OSTEOAMP, Infuse
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Bioventus LLC
Degenerative Disc Disease
Pilot Study of rhBMP-2/BCP in Patients With Spinal Degeneration With Instability Requiring Surgical Fusion
This study is designed to generate data relating to patient safety, bone generating activity associated with the use of the rhBMP-2/BCP device as compared to autograft and to evaluate the feasibility of conducting a larger…
- Trial name
- NCT01495234
- Testing
- rhBMP-2/BCP device
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Degenerative Spondylolisthesis
Evaluation Of Spinelink® Fixation In The Treatment Of Degenerative Spondylolisthesis And Spinal Instability
The purpose of this open, multi-center study is to prospectively collect outcome data on patients who are having lumbar spinal fusion surgery with implantation of the SpineLink® system.
- Trial name
- NCT00726310
- Testing
- SpineLink® , SpineLink® II
- Where
- 2 sites in United States
- Volunteers
- 202 people
- Sponsor
- Zimmer Biomet