Clinical trials: Fusion of Spine
Spine Fusion
Pedicle Screw Placement With XVS
Open label, prospective, single arm, multi-center study. Pedicle screws placement in sacral/lumbar vertebrae will be performed via open procedural technique, by at least two (2) different surgeons, using the XVISION SPINE system.
- Trial name
- NCT04682418
- Testing
- xvision Spine sytem
- Where
- 3 sites in Israel
- Volunteers
- 19 people
- Sponsor
- Augmedics
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
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
Intervertebral Disc Disease, Intervertebral Disc Degeneration
Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
- Conditions
- Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis
- Trial name
- NCT02023372
- Testing
- NuCel with Autograft
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- NuTech Medical, Inc
Spinal Fusion
Artoss Prospective Spine Registry Outcomes
This prospective registry was designed as an observational study to ascertain how commercially available NanoBone Bone Graft is being used by surgeons performing spinal fusion as well as determining relevant patient outcomes.
- Trial name
- ASTRO (NCT04439032)
- Testing
- NanoBone Bone Graft Substitute
- Where
- 6 sites in United States
- Volunteers
- 330 people
- Sponsor
- Artoss Inc.
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
Cervical Spine Disease, Pain, Postoperative
Clinical Study on the Safety and Efficacy of the Minimally Invasive Ennovate® Method for Pedicle Screw Placement
The study's main purpose is the collection of clinical data on the patients benefit and safety of pedicle screw placement through an innovative minimally invasive surgical approach compared to the state of the art open surgical…
- Trial name
- MISPEC (NCT06960018)
- Testing
- Ennovate® Cervical, open surgical technique, Ennovate® Cervical, minimal invasive surgical technique
- Where
- 3 sites in Germany
- Volunteers
- 76 people
- Sponsor
- Aesculap AG
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
Degenerative Disc Disease, Lumbar Disc Disease
LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)
The objective of this study is to evaluate the safety and effectiveness of LDGraft (investigational device) compared to 100% human tissue product allograft bone (control) when applied in an ALIF procedure in the treatment of…
- Conditions
- Degenerative Disc Disease, Lumbar Disc Disease, Spine Disease, Lumbar Spine Degeneration
- Trial name
- RESTORE (NCT06462729)
- Testing
- LDGraft, Allograft Bone
- Where
- 4 sites in United States, Australia
- Volunteers
- 40 people
- Sponsor
- Locate Bio Pty Ltd
Spinal Fusion Acquired, Fusion of Spine (Disease)
Efficacy and Safety of SurgiFill™ on Spinal Fusion
This study was designed to investigate the safety and efficacy of SurgiFill™, a bone grafting material, in patients with spinal fusion.
- Trial name
- NCT02466048
- Testing
- Spinal Fusion, SurgiFill™
- Where
- 2 sites in South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Cellontech Co., Ltd.
Degenerative Disc Disease
Natural Matrix Protein™ (NMP™) in Interbody Lumbar Fusion
The objective of this study is to evaluate the performance of Induce Biologics NMP™ when used to promote interbody fusion for degenerative disease of the lumbar spine.
- Trial name
- NCT05972616
- Testing
- Natural Matrix Protein (NMP)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Induce Biologics USA 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.
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
Degenerative Disc Disease(DDD)
Evaluation of the Safety and Effectiveness of the CORUS™ Posterior Cervical Stabilization System 3D (PCSS 3D) for the Treatment of 2-level Cervical Degenerative Disease
The objective of this clinical trial is to evaluate the treatment of patients with two-level cervical degenerative disease using a combination of Anterior Cervical Discectomy and Fusion (ACDF) and Posterior Cervical Fusion (PCF)…
- Trial name
- SECOND (NCT07721493)
- Testing
- Circumferential Cervical Fusion (CCF), Anterior Cervical Discectomy and Fusion
- Where
- United States
- Volunteers
- 225 people
- Sponsor
- Providence Medical Technology, Inc.
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 Disc Disease in Cervical Spine, Stenosis Cervical Spine
PMCF Study Fortilink-SC
This study is setup to be able to gather information on the safety and performance of the Fortilink-SC Ti cage of Paradigm Spine GmbH, up to one year after the surgery.
- Trial name
- NCT07834749
- Testing
- Cervical interbody fusion surgery (standalone)
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Fusion of Spine (Disease), Fractures, Ununited
A Clinical Registry to Collect Patient Outcome Date for the BIOMET® Stimulator Systems
The purpose of this clinical registry is to capture data on an ongoing basis from a population of patients who will use Biomet's BHS, OrthoPak and SpinalPak devices.
- Trial name
- NCT01750840
- Testing
- Biomet® EBI Bone Healing System, Biomet Orthopak® Non-Invasive Bone Growth Stimulator System, Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Zimmer Biomet
OsteoFlo HydroFiber
OsteoFlo HydroFiber Ambispective Evaluation
The goal of this observational, ambispective study is to collect real world patient outcomes to characterize the safety and effectiveness of OsteoFlo HydroFiber when used to promote fusion in the lumbar spine.
- Trial name
- NCT07784673
- Testing
- OsteoFlo HydroFiber
- Where
- 2 sites in United States
- Volunteers
- 100 people
- Sponsor
- SurGenTec LLC
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
Utilization of Autologous Mesenchymal Cells in Posterolateral Spinal Fusion in Degenerative Spine Disease
Subjects in whom a posterolateral fusion surgery has been planned and who meet the inclusion and exclusion criteria were proposed to receive a single-dose AMSC treatment, in order to assess its safety and efficacy on…
- Trial name
- AMSC-DSD-001 (NCT03827096)
- Testing
- Suspension of human autologous MSC 3P in 1.5 ml
- Volunteers
- 10 people
- Sponsor
- Bioinova, s.r.o.