Clinical trials: Degenerative Lumbar Spine Diseases
Degenerative Lumbar Spinal Stenosis
Efficacy and Tolerance Study of B-DYN Versus Conventional Fusion in the Treatment of Lumbar Stenosis on the Degree of Post-operative Functional Incapacity (BDYNCLIN)
Degenerative Lumbar Spinal Stenosis (LSS) is an extremely common condition affecting more than 102 million people each year. It is a narrowing of the spinal canal in the lower back.
- Trial name
- BDYNCLIN (NCT04407338)
- Testing
- B-DYN, Conventional Bolted fusion (with or without cage)
- Where
- 2 sites in France
- Volunteers
- 216 people
- Sponsor
- Quanta Medical
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.
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 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
Intervertebral Disc Displacement, Intervertebral Disc Degeneration
Safety and Efficacy With NOVOCART® Disc Plus (ADCT) for the Treatment of Degenerative Disc Disease in Lumbar Spine
NOVOCART® Disc plus is being investigated to explore its clinical applicability, safety and efficacy in the repair of a herniated disc with an indication for an elective sequestrectomy, and of the adjacent degenerated disc, if…
- Trial name
- NDisc (NCT01640457)
- Testing
- NOVOCART® Disc plus, NOVOCART® Disc basic
- Where
- 10 sites in Austria, Germany
- Volunteers
- 120 people
- Sponsor
- Tetec AG
Degenerative Disc Disease
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard to pain reduction and…
- Trial name
- NCT02205138
- Testing
- ALLOB® cells with ceramic scaffold
- Where
- 8 sites in Belgium
- Volunteers
- 38 people
- Sponsor
- Bone Therapeutics S.A
Degenerative Disc Disease
Pilot Study of rhBMP/BCP With or Without the TSRH® Spinal System for Posterolateral Lumbar Fusion in Patients With Degenerative Disc Disease
The purpose of this pilot clinical trial is to evaluate both device designs (rhBMP-2/BCP and rhBMP-2/BCP/TSRH® spinal System) as methods of facilitating spinal fusion as compared to instrumented fusion with autograft in patients…
- Trial name
- NCT01494441
- Testing
- rhBMP-2/BCP, rhBMP-2/BCP/TSRH® Spinal System, Autograft/TSRH® Spinal System
- Volunteers
- 27 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
An Evaluation of Interlaminar Lumbar Instrumented (ILIF™)
Patients diagnosed with single-level degenerative disc disease (DDD) of the lumbar spine undergo a posterior decompression followed by a fusion complete with a spinous process plate, graft, and a biologic.
- Trial name
- ILIF (NCT01019057)
- Testing
- ILIF
- Where
- 8 sites in United States
- Volunteers
- 77 people
- Sponsor
- NuVasive
Degenerative Disc Disease
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
- Trial name
- NCT00758719
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Zimmer Biomet
Lumbar Degenerative Disc Disease
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)
The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.
- Trial name
- NCT01293981
- Testing
- PureGen Osteoprogenitor Cell Allograft
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Alphatec Spine, Inc.
Degenerative Conditions of the Lumbar Spine
AttraX® Putty vs. Autograft in XLIF®
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
- Trial name
- NCT02250248
- Testing
- AttraX Putty, Iliac Crest Bone Graft (ICBG)
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- NuVasive
Degenerative Disc Disease, Lumbar, Disc Herniation, Lumbar
Satellite™ PEEK Nucleus Replacement Retrospective Analysis
The Satellite™ Retrospective Analysis is an international, retrospective, multi-center, non-interventional post-marketing study designed to document and analyze existing data with the device in a "real-world" setting.
- Trial name
- NCT01110967
- Where
- 3 sites in Czechia, Slovakia and 1 more
- Volunteers
- 40 people
- Sponsor
- Medtronic Spinal and Biologics
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
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 Spine Disease
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level…
- Trial name
- NCT07059065
- Testing
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix
- Where
- 5 sites in United States
- Volunteers
- 316 people
- Sponsor
- DePuy Synthes Products, Inc.
Degenerative Spondylolisthesis, Spinal Stenosis
First-In-Human Study of AK1320 Encapsulated Microspheres (AK1320 MS)
The safety and efficacy of AK1320 MS will be evaluated in patients with degenerative spondylolisthesis and concomitant symptomatic spinal stenosis who are undergoing decompression and single level instrumented posterolateral…
- Trial name
- ENHANCE (NCT04483297)
- Testing
- AK1320 MS, Control
- Where
- 7 sites in Canada
- Volunteers
- 30 people
- Sponsor
- Asahi Kasei Therapeutics Corporation
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Spinal Diseases
A-MAV™ Anterior Motion Segment Replacement
The purpose of this clinical trial is to collect safety and effectiveness data concerning the A-MAV™ Anterior Motion Segment Replacement device as a method of treating patients with lumbar degenerative disc disease at one level…
- Trial name
- NCT00635934
- Testing
- A-MAV™ disc
- Where
- 3 sites in United States
- Volunteers
- 53 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disease of the Lumbosacral Spine
Transforaminal Lumbar Interbody Fusion (TLIF)
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be…
- Trial name
- TLIF (NCT04073563)
- Testing
- Infuse™ Bone Graft (Infuse™), Intervertebral body fusion device and Medtronic posterior Fixation Systems
- Where
- 46 sites in United States, China
- Volunteers
- 600 people
- Sponsor
- Medtronic Spinal and Biologics
Degenerative Disc Disease
Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain
The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss.
- Trial name
- VAST (NCT03709901)
- Testing
- Active Allograft
- Where
- 13 sites in United States
- Volunteers
- 218 people, healthy volunteers welcome
- Sponsor
- VIVEX Biologics, Inc.