Clinical trials: Fusion of Spine, Lumbar Region
Degenerative Lumbar Spondylolisthesis
Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
Prospective, single arm, single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar (L1 - S1) spondylolisthesis. NVDX3 will be implanted during a single surgical intervention.
- Trial name
- NCT05961956
- Testing
- NVDX3
- Where
- Luxembourg
- Volunteers
- 5 people
- Sponsor
- Novadip Biosciences
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
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 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
Stenosis, Spondylolisthesis
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae)…
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT00254852
- Testing
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF)
- Where
- 6 sites in United States
- Volunteers
- 94 people
- Sponsor
- Exactech
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level…
- Trial name
- NCT02104141
- Testing
- ROIA Interbody Cage with VerteBRIDGE plating
- Volunteers
- 51 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.
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
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.
Scoliosis, Scoliosis; Adolescence
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS)…
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region
- Trial name
- PKSforPSP (NCT06554093)
- Testing
- Medical Device - PKS
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Deep Health Ltd.
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Putty Compared to Local Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Putty. MagnetOs Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with leg pain and/or back pain and undergoing…
- Trial name
- PARTNER (NCT04679896)
- Testing
- MagnetOs Putty
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Kuros Biosurgery AG
Lumbar Spinal Stenosis
Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal…
- Trial name
- NCT00529997
- Testing
- Stabilimax NZ® Dynamic Spine Stabilization System
- Where
- 19 sites in United States
- Volunteers
- 480 people
- Sponsor
- Applied Spine Technologies
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
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
A Pilot Study to Evaluate an Osteogenic Protein 1 (OP-1) Putty Spinal System and an Autograft Spinal System
This study will explore the use of recombinant OP-1 in conjunction with surgical treatment of single-level TLIF of the lumbar spine.
- Trial name
- NCT00678171
- Testing
- TLIF with a PEEK Spacer System and XIA Spinal System
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Olympus Biotech Corporation
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Trial name
- PROOF (NCT04679844)
- Testing
- MagnetOs Easypack Putty, Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Kuros Biosurgery AG
Intervertebral Disc Degeneration
Safety and Performance of the Hexanium TLIF System in the Treatment of Degenerative Disc Disease
The goal of this observational study is to confirm the safety and efficacy of the Hexanium TLIF system in the treatment of skeletally mature patients suffering from degenerative disc disease (disease that occurs when the spinal…
- Trial name
- TLIF (NCT05997121)
- Testing
- Transforaminal lumbar interbody fusion
- Where
- 6 sites in France, Switzerland
- Volunteers
- 187 people
- Sponsor
- SPINEVISION SAS
Transforaminal Lumbar Interbody Fusion Surgery
A Post-marketing Study to Evaluate a Novel Surgical Monitoring Technique Using the EARP Nerve Cuff in TLIF Surgery.
The purpose of this study is to evaluate the differences (the effectiveness and the safety) between two different nerve and muscle monitoring devices currently available during a TLIF surgery.
- Trial name
- NCT06204900
- Testing
- Nerve Cuff and Retractor System
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Retropsoas Technologies, LLC
Degenerative Disc Disease, Spinal Stenosis
Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine
nanOss Bioactive is approved for use in the U.S. The purpose of this study is to compare fusion results in the posterolateral spine using nanOss Bioactive mixed with autograft bone and bone marrow aspirate (BMA) on one side and…
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01968993
- Testing
- nanOss Bioactive - posterolateral gutter
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Pioneer Surgical Technology, Inc.