Clinical trials: Intervertebral Disc, Degenerative
Degenerative Disc Disease
Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Symptomatic Degenerative Disc Disease
This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® device as compared to the LT-CAGE® device with autogenous bone in patients with symptomatic degenerative disc disease using an open…
- Trial name
- NCT01491386
- Testing
- rhBMP-2/ACS/LT-CAGE® Device, Autogenous Bone/LT-CAGE® Device
- Volunteers
- 279 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
Osteocel® Plus in Transforaminal Lumbar Interbody Fusion (TLIF)
This study is being conducted to determine the percentage of patients with solid spinal fusions after being treated with Osteocel Plus in a TLIF procedure.
- Trial name
- NCT00947583
- Testing
- Osteocel Plus
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NuVasive
Radiculopathy, Herniated Disc
Regenexx™ PL-Disc Versus Steroid Epidurals for Lumbar Radiculopathy
The primary objective of this study is to compare the improvement in subject-reported clinical outcomes for Regenexx PL-Disc vs.
- Conditions
- Radiculopathy, Herniated Disc, Disc Degeneration
- Trial name
- NCT01850771
- Testing
- Regenexx PL-Disc, Steroid Epidural
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Regenexx, LLC
Degenerative Disc Disease
Post-Market Surveillance Study of the TM Ardis Interbody Fusion System
This study is a post-market clinical follow-up study to fulfill the post-market surveillance obligations according to Medical Device Directive and MEDDEV 2.12-2_Rev2_January 2012.
- Trial name
- NCT02429908
- Testing
- TM-Ardis Interbody
- Where
- 10 sites in Belgium, Canada and 4 more
- Volunteers
- 80 people
- Sponsor
- Zimmer Biomet
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
Degenerative Disc Disease
A Pivotal Study of rhBMP-2/ACS/LT-CAGE® Device for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
This study is designed to assess the safety and effectiveness of the rhBMP-2/ACS/LT-CAGE® Device using laparoscopic surgical technique as compared to an historical control group treated with Autogenous Bone/LT-CAGE® Device using…
- Trial name
- NCT01491425
- Testing
- rhBMP-2/ACS//LT-CAGE® Device, Autogenous Bone//LT-CAGE® Device
- Volunteers
- 134 people
- Sponsor
- Medtronic Spinal and Biologics
Disk Herniated Lumbar, Disc Disease Degenerative
Clinical Outcome and Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages
Prospective, Randomized, Single-Blind Study for the Evaluation of the Clinical Outcome and the Fusion Rate of 3D Printed Interbody Fusion Cages and Titanium Coated PEEK Cages in Transforaminal Lumbar Interbody Fusion
- Conditions
- Disk Herniated Lumbar, Disc Disease Degenerative, Spondylolisthesis
- Trial name
- PRINTLIF (NCT05237908)
- Testing
- Transforaminal Lumbar Interbody Fusion
- Where
- Germany
- Volunteers
- 78 people
- Sponsor
- Aesculap AG
Degenerative Disc Disease
Maverick Total Disc Replacement in a 'Real World' Patient Population
The primary purpose of the study is to document the reduction of disability after Maverick total disc replacement surgery in a 'real-world' patient population requiring disc replacement.
- Trial name
- Maverick (NCT01338493)
- Testing
- lumbar spinal arthroplasty + Maverick™
- Where
- 13 sites in Canada, France and 1 more
- Volunteers
- 139 people
- Sponsor
- Medtronic Spinal and Biologics
Chronic Low Back Pain, Degenerative Disc Disease
Facet Wedge Post Market Study
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint…
- Conditions
- Chronic Low Back Pain, Degenerative Disc Disease, Facet Joint Disease, Pseudo Arthrosis Post Anterior Instrumentation
- Trial name
- NCT02203448
- Testing
- Facet Wedge spinal system
- Where
- 3 sites in Germany, Slovakia
- Volunteers
- 50 people
- Sponsor
- Synthes GmbH
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.
Degeneration of Lumbar Intervertebral Disc
Pilot Study of rhBMP-2/ACS/LT-CAGE® for Anterior Lumbar Interbody Fusion in Patients With Degenerative Disc Disease
This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in…
- Trial name
- NCT01491373
- Testing
- rhBMP-2/ACS/LT-CAGE® Device, Autograft/LT-CAGE® Device
- Volunteers
- 14 people
- Sponsor
- Medtronic Spinal and Biologics
Vertebral Cervical Fusion Syndrome, Degenerative Disc Disease
Study Using the CervicalStim Device Following Cervical Fusion
This study examines the effect of adjunctive use of the CervicalStim bone growth stimulator on cervical fusion rate in high risk subjects who have undergone cervical fusion surgery.
- Trial name
- NCT03177473
- Testing
- CervicalStim bone growth stimulator
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- Orthofix Inc.
Degenerative Disc Disease
Efficacy and Safety of Rexlemestrocel-L Combined With HA* in Participants With Moderate to Severe Chronic Low Back Pain
The primary purpose of this study is to evaluate the efficacy of rexlemestrocel-L+HA compared to control in reducing low back pain at 12 months post-treatment and safety of a single injection of rexlemestrocel-L+HA injected into…
- Trial name
- HyaluronicAcid (NCT06325566)
- Testing
- Rexlemestrocel-L + HA mixture, Saline
- Where
- 40 sites in United States
- Volunteers
- 300 people
- Sponsor
- Mesoblast, Ltd.
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
Back Pain, Chronic Low Back Pain
Treatment of Symptomatic Lumbar Internal Disc Disruption (IDD) With the Biostat® System
The purpose of this investigation is to establish the safety and efficacy of the Biostat System when used for treatment of chronic low back (lumbar) pain due to symptomatic internal disc disruptions (IDD) by comparing safety and…
- Conditions
- Back Pain, Chronic Low Back Pain, Internal Disc Disruption, Degenerative Disc Disease
- Trial name
- NCT01011816
- Testing
- BIOSTAT BIOLOGX, Saline
- Where
- 20 sites in United States
- Volunteers
- 220 people
- Sponsor
- Spinal Restoration, Inc.
Degenerative Disc Disease
XL TDR® eXtreme Lateral Total Disc Replacement for the Treatment of Lumbar Degenerative Disc Disease (DDD)
The purpose of this study is to evaluate the safety and effectiveness of XL TDR in patients with single-level degenerative disc disease compared to other devices approved by the FDA for the same or similar indications.
- Trial name
- XL TDR (NCT00927238)
- Testing
- XL TDR, Lumbar fusion surgery
- Where
- 17 sites in United States
- Volunteers
- 246 people
- Sponsor
- NuVasive
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
Pseudoarthrosis, Spinal Stenosis
A Study Comparing Fusion Rates of Two Lumbar Fusion Procedures
The purpose of this study is to demonstrate the relative efficacy of two lumbar fusion procedures: transacral lumbar interbody fusion when used in conjunction with unilateral or bilateral posterior pedicle screw fixation as an…
- Conditions
- Pseudoarthrosis, Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- Trial name
- NCT01972256
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Baxano Surgical, Inc.
Scoliosis, Back Pain
InterFuse® S and T for the Treatment of Scoliosis, Spondylolisthesis and Degenerative Disc Disease (DDD)
The primary objective of this prospective, post-market study is to collect data to assess the long term outcome of a broad contact modular interbody device in the form of the InterFuse S™ or InterFuse T™ device in patients…
- Trial name
- NCT02659722
- Testing
- InterFuse
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Vertebral Technologies, Inc.