Clinical trials: Spondylolysis Lumbar
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
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
Spondylolisthesis, Scoliosis
A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
OsteoAMP is a novel allograft bone graft substitute (BGS) that has been processed to retain multiple endogenous growth factors for use in spinal fusion.
- Conditions
- Spondylolisthesis, Scoliosis, Intervertebral Disc Disease
- Trial name
- NCT02225444
- Testing
- OsteoAMP
- Where
- 9 sites in United States
- Volunteers
- 42 people
- Sponsor
- Bioventus LLC
Prolapsed Lumbar Disc, Prolapsed Cervical Disc
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and…
- Conditions
- Prolapsed Lumbar Disc, Prolapsed Cervical Disc, Intervertebral Disc Degeneration, Spondylolisthesis, Grade 1
- Trial name
- NCT01944345
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- Wenzel Spine
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.
Degenerative Disc Disease, Osteochondrosis
MySpine MC Versus MySpine Standard
This research project compares the clinical performance of the cortical bone trajectory CBT insertion technique with the current clinical Gold standard, the Pedicle screw insertion technique.
- Conditions
- Degenerative Disc Disease, Osteochondrosis, Spondylolysis Lumbar
- Trial name
- MC vs STD (NCT05846477)
- Testing
- MySpine
- Where
- Switzerland
- Volunteers
- 44 people
- Sponsor
- Medacta International SA
Degenerative Disc Disease, Spinal Stenosis
Effectiveness of Lumbar Fusion When NanOss Bioactive Is Used With Posterolateral Gutter Fusions
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01452516
- Testing
- nanOss Bioactive Bone void filler, Interbody FCage
- Where
- 7 sites in United States
- Volunteers
- 28 people
- Sponsor
- Pioneer Surgical Technology, 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
Spinal Stenosis, Low Back Pain
Total Facet Arthroplasty System®(TFAS®) Clinical Trial
The Archus Total Facet Arthroplasty System® (TFAS®) is a non-fusion spinal implant indicated for treatment of patients with moderate to severe spinal stenosis. TFAS® replaces the diseased facets following surgical removal.
- Conditions
- Spinal Stenosis, Low Back Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00418197
- Testing
- Total Facet Arthroplasty System® (TFAS®)
- Volunteers
- 450 people
- Sponsor
- Archus Orthopedics, Inc.
Spondylosis, Cervical Spondylosis
ViBone in Cervical and Lumbar Spine Fusion
Assess clinical and radiographic outcomes in patients who undergo 1-3 level anterior cervical discectomy fusion (ACDF) or lumbar interbody fusion (TLIF, PLIF, ALIF, or LLIF) using ViBone.
- Conditions
- Spondylosis, Cervical Spondylosis, Spondylolisthesis, Herniated Nucleus Pulposus
- Trial name
- NCT03425682
- Testing
- ViBone
- Where
- 4 sites in United States
- Volunteers
- 118 people
- Sponsor
- Elutia Inc.
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Kore Fiber PLF Study
This is a prospective, randomized controlled trial evaluating Kore Fiber® versus autograft in adults undergoing posterolateral lumbar fusion (PLF).
- Conditions
- Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT07868510
- Testing
- Kore Fiber, Autologous bone graft
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Kolosis Bio, LLC
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced Interbody Cages in the Lumbar Spine
The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo interbody spinal fusion using the EVOS Lumbar Interbody System.
- Trial name
- NCT03928041
- Testing
- Device: EVOS Lumbar Interbody System (EVOS-HA)
- Where
- 2 sites in United States
- Volunteers
- 22 people
- Sponsor
- Invibio Ltd
Spinal Stenosis, Spondylolisthesis
Retrospective, Multicenter Clinical Evaluation of Health Economic Drivers and Complications for Two Lumbar Fusion Procedures
The purpose of this retrospective data review is to evaluate the health economic drivers and complications of two surgical procedures: transsacral lumbar interbody fusion and transforaminal lumbar interbody fusion when used in…
- Conditions
- Spinal Stenosis, Spondylolisthesis, Degenerative Disc Disease (DDD)
- Trial name
- NCT02171169
- Where
- 3 sites in United States
- Volunteers
- 200 people
- Sponsor
- Baxano Surgical, Inc.
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.
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.
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
PMCF Study Fortilink-TS Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-TS Ti cage of Paradigm Spine GmbH, up to one-year after the surgery.
- Trial name
- NCT07834736
- Testing
- Posterior lumbar interbody fusion surgery
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Degenerative Disc Disease, Spinal Stenosis
SPIRA™-A 3D and HCT/p DBM vs. Medtronic Divergent™-L/Perimeter™ and Recombinant BMP-2
A prospective, randomized, controlled clinical evaluation utilizing the SPIRA™ ALIF 3-D printed titanium interbody device with DBM vs a Medtronic PEEK ALIF interbody device with BMP
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Scoliosis
- Trial name
- NCT04566874
- Testing
- ALIF
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- Camber Spine Technologies
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
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
Spondylolisthesis
Safety and Preliminary Effectiveness of NVD-001 for the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
A prospective multi-centre, randomised, controlled study to evaluate the safety and preliminary effectiveness of NVD-001 for the treatment of low grade degenerative lumbar spondylolisthesis by interbody fusion (L1 - S1).
- Trial name
- Spine1 (NCT03100032)
- Testing
- NVD-001, Standard of Care
- Where
- 12 sites in Belgium, Czechia and 1 more
- Volunteers
- 48 people
- Sponsor
- Novadip Biosciences