Clinical trials: Spine Degeneration
Cervical Radiculopathy, Degenerative Disc Disease
Restore CLINICAL TRIAL
This is a prospective, concurrently controlled, multi-center study to evaluate the safety and effectiveness of the Spinal Kinetics M6-C artificial cervical disc compared to anterior cervical discectomy and fusion (ACDF) for the…
- Trial name
- NCT01609374
- Testing
- M6-C Artificial Cervical Disc, Anterior plate system with corticocancellous allograft bone
- Volunteers
- 258 people
- Sponsor
- Spinal Kinetics
Cervical Degenerative Disc Disease, Radiculopathy
Study of the Safety and Effectiveness of the Artificial Cervical Disc - Low Profile Device at Two Adjacent Levels
The purpose of this clinical investigation is to assess the safety and effectiveness of using the PRESTIGE-LP device in the treatment of patients with symptomatic degenerative disc disease at two adjacent levels of the cervical…
- Conditions
- Cervical Degenerative Disc Disease, Radiculopathy, Myelopathy
- Trial name
- NCT00637156
- Testing
- PRESTIGE LP device at two adjacent levels, Bi-level fusion with ATLANTIS Cervical Plate System
- Where
- 29 sites in United States
- Volunteers
- 397 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF…
- Trial name
- MASTERS-D (NCT01143324)
- Testing
- MAST™ procedure
- Where
- 19 sites in Austria, Belgium and 12 more
- Volunteers
- 255 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Idys™ TLIF 3DTi Post Market Clinical Follow-up
The aim of this observational post-marketing study is to provide additional information on the safety and effectiveness of Idys™ TLIF 3DTi at up to 24 months post transforaminal lumbar fusion in usual surgical practice.
- Trial name
- NCT04584619
- Testing
- Spine fusion surgery with Clariance Idys TLIF 3DTi
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Clariance
Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis
The Degen Study: Post-market Clinical Follow-up on the PASS LP, PASS Degen and PASS Tulip Systems (PASS DEGEN)
The purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the MEDICREA's systems PASS LP, PASS DEGEN, and PASS Tulip PRIME to treat degenerative diseases.
- Conditions
- Thoracolumbar Disc Degeneration, Thoracolumbar Spondylolisthesis, Spinal Deformity, Spinal Degeneration
- Trial name
- PASS DEGEN (NCT04670536)
- Testing
- PASS LP implants, PASS DEGEN, PASS TULIP PRIME
- Where
- 4 sites in France
- Volunteers
- 77 people
- Sponsor
- Medicrea International
Degenerative Disc Disease, Spondylolisthesis
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Retrolisthesis
- Trial name
- NCT04416321
- Testing
- Surgery with the Keos Lumbar Interbody Fusion Device
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Invibio Ltd
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative…
- Trial name
- NCT02104167
- Testing
- ROIC interbody cage with VerteBRIDGE plating
- Where
- 7 sites in United States
- Volunteers
- 110 people
- Sponsor
- LDR Spine USA
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.
Intervertebral Disc Replacement, Degenerative Disc Disease
Activ C European Multicenter Study
Patients are candidates for single-level Artificial Disc Replacement between C3 and C7 who suffer from cervical symptomatic degenerative disc disease. A maximum of 200 cases will be enrolled into the study.
- Trial name
- NCT02492724
- Where
- 10 sites in Czechia, Finland and 3 more
- Volunteers
- 210 people
- Sponsor
- Aesculap AG
Degenerative Disc Disease (DDD), Instabilities
PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use.
In accordance with the European Medical Device Regulation MDR 2017/745/EU, the legal manufacturers of medical devices are obliged to evaluate medical devices with regard to their clinical performance and safety.
- Conditions
- Degenerative Disc Disease (DDD), Instabilities, Trauma, Deformity
- Trial name
- NCT05489822
- Testing
- VERTICALE® Cervical System
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Silony Medical GmbH
Stenosis, Spondylosis
Efficacy and Safety of Integra Accell Evo3 DBM in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented lumbar spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01714804
- Testing
- Accell Evo3 Prospective Use
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- SeaSpine, Inc.
Spondylosis, Spinal Stenosis
A Prospective Study of NuCel® in Cervical Spine Fusion
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
- Conditions
- Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease
- Trial name
- NCT02381067
- Testing
- NuCel with Allograft Bone
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- NuTech Medical, Inc
Lumbar Spine Degeneration
3Spine Lumbar Fusion Real World Evidence Study
This study is designed to collect real world evidence (RWE) safety and efficacy data on patients who plan to undergo a single-level Transforaminal lumbar interbody fusion (TLIF) or Posterior lumbar interbody fusion (PLIF)…
- Trial name
- NCT04823858
- Testing
- Lumbar Interbody Fusion
- Where
- 20 sites in United States
- Volunteers
- 176 people
- Sponsor
- 3Spine
Intervertebral Disk Degeneration
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and…
- Trial name
- NCT00310440
- Testing
- P-15 Synthetic osteoconductive bone substitute, Autologous bone
- Where
- 12 sites in United States, Canada
- Volunteers
- 319 people
- Sponsor
- CeraPedics, Inc
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
Titan Spine Endoskeleton TT/TO Study
This is a prospective, multi-center controlled observational clinical study. All subjects will receive Titan Endoskeleton TT/TO acid etched titanium implant for the planned procedure.
- Trial name
- NCT03910309
- Testing
- TLIF with Titan TT/TO interbody cage
- Where
- 8 sites in United States
- Volunteers
- 75 people
- Sponsor
- Titan Spine
Degenerative Disc Disease, Cervical Spine Degenerative Disease
Retrospective Analysis of Patients Implanted With 2 Levels of Prodisc® C Vivo Devices
The objective of the study is to evaluate the safety and post-operative performance profile of the prodisc® C Vivo after implantation in comparison to the relevant clinical literature.
- Conditions
- Degenerative Disc Disease, Cervical Spine Degenerative Disease, Symptomatic Cervical Disc Disease, Cervical Spine Degenerative Disc Disease
- Trial name
- NCT07370493
- Testing
- Prodisc C Vivo
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Centinel Spine
Degenerative Disc Disease, Spinal Stenosis
Spine Patient Outcomes Registry for Biomet/EBI (Electro-Biology, Inc)
The purpose of this patient registry is to prospectively collect data on patients who are having spinal surgery with EBI and Interpore Cross Spine Products.
- Trial name
- SPO (NCT00726284)
- Where
- 5 sites in United States
- Volunteers
- 651 people, healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Cervical Disc Degeneration
Real World Data Collection on the Synergy Cervical Disc
This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with…
- Trial name
- NCT05305430
- Testing
- Synergy Cervical Disc System
- Where
- Australia
- Volunteers
- 200 people
- Sponsor
- Synergy Spine Solutions
Intervertebral Disc Degeneration
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal…
- Trial name
- FixedD3 (NCT06342765)
- Testing
- Pedicle fixation surgery
- Where
- 3 sites in France
- Volunteers
- 330 people
- Sponsor
- SPINEVISION SAS