Clinical trials: Spinal (Fusion) Surgery
Disc Degenerative Disease, Spondylolisthesis
A Clinical Study of a Spine Fusion System in Vertebral Body Fusion Surgery
The primary objective of this study is to demonstrate that the efficacy and safety of Spine fusion system manufactured in China is no inferior than imported product.
- Conditions
- Disc Degenerative Disease, Spondylolisthesis, Spinal Fracture, Spinal Deformity
- Trial name
- NCT02252185
- Testing
- Johnson&Johnson Medical Suzhou made Spine Fusion System, Imported EXPEDIUM screws and OPAL cage
- Where
- 8 sites in China
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical (Suzhou) Ltd.
Degenerative Disc Disease
Actifuse ABX Versus INFUSE in Posterolateral Instrumented Lumbar Fusion
This is a prospective randomised study. Primary objective: Evaluation of success rates of Actifuse ABX and INFUSE in achieving bone fusion. Secondary objectives: Assess clinical outcome measurements.
- Trial name
- APPRAISET2 (NCT01018771)
- Testing
- Actifuse ABX, INFUSE, plus Mastergraft granules
- Where
- Australia
- Volunteers
- 100 people
- Sponsor
- Baxter Healthcare Corporation
Cervical Stenosis, Spondylolisthesis
Effectiveness of AlloWrap® for the Reduction of Inflammation in ACDF Procedures
The primary objective of this study is to obtain evidence of the effectiveness of AlloWrap Amniotic Membrane in the reduction of soft tissue swelling in two-level ACDF procedures.
- Conditions
- Cervical Stenosis, Spondylolisthesis, Cervical Radiculopathy, Cervical Disc Disorder
- Trial name
- NCT04684901
- Testing
- AlloWrap® Amniotic Membrane
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- AlloSource
Acquired Bleeding Disorder, Spinal Fusion
Use of Activated Recombinant FVII in Spinal Surgery
This trial is conducted in the United States of America (USA). The purpose of this clinical research trial is to understand how safe and effective Recombinant Activated FVII is for reducing bleeding and blood transfusions in…
- Trial name
- NCT00102037
- Testing
- eptacog alfa (activated)
- Where
- 14 sites in United States
- Volunteers
- 50 people
- Sponsor
- Novo Nordisk A/S
Spinal Cord Neoplasms, Spinal Fractures
The Development of a Vertebra Localizing Aid Medical Device
The current method of incision localization in many surgical procedures requires a doctor to reference a medical image, such as an X-ray, to judge where on the body an incision should be made.
- Trial name
- NCT02603874
- Testing
- Target Tape
- Volunteers
- 100 people
- Sponsor
- Target Tape
Intervertebral Disc Degeneration
Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery
The purpose of this study is to collect on-label safety and efficacy data where InQu Bone Graft Extender is applied to transforaminal lumbar interbody fusion (TLIF) and posterior lumbar interbody fusion (PLIF).
- Trial name
- Intebody (NCT02400762)
- Where
- 2 sites in United States
- Volunteers
- 130 people
- Sponsor
- ISTO Technologies, Inc.
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.
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, Herniated Disc
Bone Graft Materials Observational Registry
A multi-center, prospective, observational patient registry to collect information on the clinical outcomes and "real world" use of approved and commercially available bone graft substitutes, autograft and allograft.
- Conditions
- Degenerative Disc Disease, Herniated Disc, Spinal Stenosis, Spondylolithesis
- Trial name
- APPROACH-001 (NCT00974623)
- Testing
- Bone graft substitute, autograft or allograft
- Where
- 14 sites in United States, Hungary and 1 more
- Volunteers
- 329 people
- Sponsor
- Baxter Healthcare Corporation
Blood Loss, Surgical, Postoperative Hemorrhage
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7…
- Trial name
- NCT00327379
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 14 sites in Canada, Germany and 1 more
- Volunteers
- 54 people
- Sponsor
- Bayer
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
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 Disc Disease, Spinal Stenosis
New Robotic Assistance System for Spinal Fusion Surgery
The main objectives of the study are to evaluate the acceptance into operating flow, performance and safety of the AQrate Robotic Assisted System during the spinal fusion surgery
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- AQrate (NCT02558621)
- Testing
- AQrate Robotic Assistance System
- Where
- 2 sites in Switzerland
- Volunteers
- 24 people
- Sponsor
- KB Medical SA
Failed Lumbar Fusion
Study on Allogeneic Osteoblastic Cells Implantation in Rescue Interbody Fusion
Failed fusion and failure to relieve back pain following spinal fusion are still frequent, irrespective of the type of procedures or grafts used by the surgeon.
- Trial name
- NCT02328287
- Testing
- ALLOB®
- Where
- 3 sites in Belgium
- Volunteers
- 6 people
- Sponsor
- Bone Therapeutics S.A
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
Cervical Degenerative Disc Disease
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
A multicenter, prospective, non-randomized, historically controlled study. To demonstrate the Synergy Disc is at least as safe and effective as conventional anterior cervical discectomy and fusion (ACDF) to treat cervical…
- Trial name
- NCT05740176
- Testing
- Anterior Cervical Discectomy and Fusion
- Where
- 23 sites in United States
- Volunteers
- 200 people
- Sponsor
- Synergy Spine Solutions
Scoliosis
Evaluate Initial Safety of the HemiBridge™ System in Guided Spinal Growth Treatment of Progressive Idiopathic Scoliosis
The purpose of this clinical trial is to study a new method of treatment for patients who are diagnosed with idiopathic scoliosis and have abnormal and increasing curvature of the spine.
- Trial name
- NCT01465295
- Testing
- Mechanical hemiepiphysiodesis using the HemiBridge System
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- SpineForm LLC
Degenerative Disc Disease
Comparative Analysis of Virtuos and Autograft in Lumbar Fusion
Compare the lumbar fusion rates at 12 and 24 months when lumbar arthrodesis is performed using Virtuos or Autograft Bone Graft. Surgical approach is limited to TLIF (MIS or Open) with posterior fixation and supplemental…
- Trial name
- NCT05614284
- Testing
- Virtuos
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Orthofix Inc.
Staphylococcal Vaccine
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of…
- Trial name
- STRIVE (NCT02388165)
- Testing
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
- Where
- 301 sites in United States, Austria and 9 more
- Volunteers
- 3,450 people
- Sponsor
- Pfizer
Degenerative Disc Disease, Craniocervical Injuries
Posterior Cervical Fixation Study
The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported…
- Conditions
- Degenerative Disc Disease, Craniocervical Injuries, Cervical Radiculopathy, Cervical Disc Disease
- Trial name
- NCT04770571
- Testing
- observational study
- Where
- 7 sites in United States
- Volunteers
- 150 people
- Sponsor
- NuVasive