Clinical trials: Disorder of Spine
Spinal Tumor, Spinal Injury
Study of Collagen-Based Thrombin Hemostat for the Control of Bleeding in Spinal Surgery
This clinical trial evaluates the effectiveness and safety of a collagen-based hemostatic agent containing thrombin in patients undergoing spinal surgery.
- Conditions
- Spinal Tumor, Spinal Injury, Hemostasis, Spinal Stenosis
- Trial name
- NCT07354178
- Testing
- CollaStat®, Floseal®
- Where
- 3 sites in South Korea
- Volunteers
- 130 people
- Sponsor
- DALIM TISSEN Co., Ltd.
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Low Back Pain
Wallis Stabilization System for Low Back Pain
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar…
- Trial name
- NCT00484458
- Testing
- Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement
- Where
- 11 sites in United States
- Volunteers
- 340 people
- Sponsor
- Zimmer Spine
Arthritis, Psoriatic
A Study of Guselkumab in Participants With Active Psoriatic Arthritis
The purpose of this study is to evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.
- Trial name
- APEX (NCT04882098)
- Testing
- Guselkumab
- Where
- 280 sites in United States, Australia and 27 more
- Volunteers
- 1,054 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease, Ulcerative Colitis
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the…
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Trial name
- ReFLECT (NCT02925338)
- Testing
- QOL questionaire
- Where
- 67 sites in France
- Volunteers
- 1,431 people
- Sponsor
- Pfizer
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.
Spondylolisthesis, Retrolisthesis
A Study Evaluating 3-Level OLIF Spine Fusion
The purpose of this study is to assess clinical and radiographic outcomes in patients who undergo three-level oblique lateral lumbar interbody fusion (OLIF) using ViBone, demineralized bone matrix (DBM), and bone morphogenetic…
- Conditions
- Spondylolisthesis, Retrolisthesis, Degenerative Disc Disease
- Trial name
- NCT03896347
- Testing
- ViBone®, Demineralized Bone Matrix, Bone Morphogenetic Protein
- Sponsor
- Elutia Inc.
Pharmacokinetics, Safety Issues
A Clinical Study With Adalimumab Biosimilar
The study aims to evaluate the pharmacokinetic profile, safety profile, and immunogenic potential of adalimumab of a new citrate-free formulation of adalimumab (Adalimumab Richmond) [Test Product] vs.
- Trial name
- NCT06291948
- Testing
- Humira® (adalimumab) AC Pen [Reference Product], Adalimumab Richmond [Test Product]
- Where
- Argentina
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Laboratorios Richmond S.A.C.I.F.
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.
Intervertebral Disc Degeneration, Stenosis, Spinal
Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure
This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using saphenous nerve as the site of stimulation to identify changes to the lumbar nerves which may be at risk…
- Conditions
- Intervertebral Disc Degeneration, Stenosis, Spinal, Spondylolisthesis, Spinal Deformity
- Trial name
- NCT05648474
- Testing
- Somatosensory evoked potential [SSEP] intraoperative monitoring
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alphatec Spine, Inc.
Lumbar Spinal Stenosis
Feasibility Study of NL-Prow Interspinous Spacer to Treat Lumbar Spinal Stenosis
The purpose of the study is to evaluate the clinical safety and feasibility of the NL-Prow™ Interspinous Spacer implant and insertion procedure in the treatment of lumbar spinal stenosis
- Trial name
- NCT01053364
- Testing
- NL-Prow interspinous spacer implant
- Where
- Czechia
- Volunteers
- 6 people
- Sponsor
- Non-Linear Technologies
Degenerative Disc Disease
Titanium Surgical Mesh and MOSS-Miami Screws for Lumbar Fusion.
The purpose of this study is to determine the clinical success of DePuy Spine Titanium Surgical Mesh with MOSS Miami Spinal Fixation System Pedicle Screws in the treatment of one or two levels of degenerative disc disease of the…
- Trial name
- NCT00215319
- Testing
- Lumbar I/F with cage and pedicle screws
- Where
- 2 sites in United States
- Volunteers
- 139 people
- Sponsor
- DePuy Spine
Herniated Disc, Radiculopathy
Slotted Hole Versus Fixed Hole C-Tek
The purpose of this study is to compare the fusion rates between the EBI, LLC C-Tek™ Anterior Cervical Plate, Slotted Hole Design versus the Fixed Hole Design.
- Conditions
- Herniated Disc, Radiculopathy, Spondylolysis
- Trial name
- NCT00585923
- Testing
- Fixed hole C-Tek™ Plate, Slotted hole C-Tek™ Plate
- Where
- United States
- Volunteers
- 115 people
- Sponsor
- Zimmer Biomet
Psoriatic Arthritis
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis (PsA)
The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis who have not been previously treated with DMARDs.
- Trial name
- PALACE4 (NCT01307423)
- Testing
- Apremilast 20mg, Apremilast 30mg
- Where
- 118 sites in United States, Australia and 16 more
- Volunteers
- 529 people
- Sponsor
- Amgen
Spinal Stenosis
Neurogenic Intermittent Claudication Evaluation Study
The objective of the NICE study is to provide clinical evidence proving that the Aperius™ PercLID™ System is safe and non-inferior to standalone decompressive surgery with regards to clinical outcomes in patients suffering from…
- Trial name
- NICE (NCT00905359)
- Testing
- Aperius™ PercLID™ System, Standalone Decompressive Surgery
- Where
- 19 sites in Australia, Belgium and 8 more
- Volunteers
- 163 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Spine Stenosis, Lumbar Spine Degeneration
OpalGenix- Personalized Postoperative Pain Management Following Lumbar Spinal Fusion and Decompression Surgery in Adults
The proposed research is an important extension of an ongoing perioperative personalized analgesia and intravenous opioid pharmacogenetic research.
- Trial name
- NCT05452694
- Where
- 3 sites in United States
- Volunteers
- 235 people
- Sponsor
- OpalGenix, Inc
Lumbar Degenerative Disc Disease, Lower Back Pain
Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine
Investigate the potential of tissue grafting that includes human mesenchymal stem cells in the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo and at the time of surgical reconstruction.
- Conditions
- Lumbar Degenerative Disc Disease, Lower Back Pain, Chronic Lower Back Pain
- Trial name
- NCT02529566
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Foundation for Spinal Research, Education and Humanitarian Care, Inc.
Metastatic Lesions in Vertebral Bodies
Evaluation of t-RFA and RF-TVA Prior to/Following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)
The purpose of this study is to evaluate treating painful metastatic lesions in vertebral bodies with pathologic fractures with targeted radiofrequency ablation (t-RFA) and vertebral augmentation (VA) prior to or following…
- Trial name
- STARRT (NCT02225223)
- Testing
- STAR™ Tumor Ablation System, StabiliT® Vertebral Augmentation System
- Where
- 14 sites in United States
- Volunteers
- 35 people
- Sponsor
- Merit Medical Systems, Inc.
Ankylosing Spondylitis
Assial - Anti Tnf Treatment in Ankylosing Spondylitis: an Observational Cohort Study in Italy
Observe in real life adherence therapy and time to switch in ankylosing spondylitis patients with predominant assial involvement with 4 anti-TNF.
- Trial name
- ASSIAL (NCT01856569)
- Testing
- no intervention
- Where
- 18 sites in Italy
- Volunteers
- 152 people
- Sponsor
- Pfizer
Psoriasis, Arthritic
A Study of Ixekizumab in Participants With Active Psoriatic Arthritis
This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.
- Trial name
- SPIRIT-P1 (NCT01695239)
- Testing
- Ixekizumab, Adalimumab
- Where
- 116 sites in United States, Belgium and 13 more
- Volunteers
- 417 people
- Sponsor
- Eli Lilly and Company