Clinical trials: Spinal Instrumentation
Spinal Diseases
Observational Clinical Study to Plan, Position and Check Instrument Placement for Spine Surgery Interventions
There is a clear need in spine surgery to place pedicle screws in the right place in the spine with good accuracy to avoid damage to important structures (spinal cord, nerve roots or vertebral arteries).
- Trial name
- NCT03015142
- Testing
- New image-guidance software
- Where
- Sweden
- Volunteers
- 21 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1.
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00996073
- Testing
- Lumbar Interbody Fusion with Autograft, Lumbar Interbody Fusion with NeoFuse
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- Mesoblast, Ltd.
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
P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation
The aim of this trial is to evaluate if P-15L bone graft (investigational device) is not inferior in effectiveness and safety to local autologous bone (and allograft where necessary) as an extender (control device) when applied…
- Trial name
- NCT03438747
- Testing
- P-15L Bone Graft, Local autologous bone in a TLIF with Instrumentation
- Where
- 34 sites in United States
- Volunteers
- 290 people
- Sponsor
- CeraPedics, Inc
Intervertebral Disk Degeneration
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and…
- Trial name
- NCT00310440
- Testing
- P-15 Synthetic osteoconductive bone substitute, Autologous bone
- Where
- 12 sites in United States, Canada
- Volunteers
- 319 people
- Sponsor
- CeraPedics, Inc
Degenerative Disc Disease, Spondylolisthesis
Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF)
This is a first-in-human, dose escalation clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture-expanded, nucleated, allogeneic MPCs (NeoFuse) when combined with…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00549913
- Testing
- NeoFuse, posterolateral spinal fusion with instrumentation
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mesoblast, Ltd.
Idiopathic Scoliosis
Scoliosis Surgery Using the PASS® LP System
The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the…
- Trial name
- NCT01019109
- Testing
- Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.
- Where
- 3 sites in United States
- Volunteers
- 79 people
- Sponsor
- Medicrea, USA Corp.
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
Chronic Low Back Pain, Degenerative Disc Disease
Facet Wedge Post Market Study
A Multi-centre, Prospective, single-arm post market clinical follow up study (PMCF) of the FACET WEDGETM spinal system to assess outcomes in subjects with chronic low back pain due to Degenerative Disc Disease (DDD), facet joint…
- Conditions
- Chronic Low Back Pain, Degenerative Disc Disease, Facet Joint Disease, Pseudo Arthrosis Post Anterior Instrumentation
- Trial name
- NCT02203448
- Testing
- Facet Wedge spinal system
- Where
- 3 sites in Germany, Slovakia
- Volunteers
- 50 people
- Sponsor
- Synthes GmbH
Degenerative Disc Disease, Degenerative Spondylolisthesis
Safety and Efficacy Study of NeoFuse in Subjects Requiring Posterolateral Lumbar Fusion
The purpose of this study is to evaluate safety and preliminary efficacy of Neofusetm in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1 and undergoing…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Spinal Stenosis
- Trial name
- NCT00810212
- Testing
- PLF with autograft, PLF with NeoFuse
- Where
- United States
- Sponsor
- Mesoblast, Ltd.
Degenerative Spine Disease, Spinal Deformity
Prospective, Observational Registry of Renaissance-guided Spine Surgeries
To establish an observational registry for systematic collection of clinical data from Renaissance-guided spine surgeries.
- Trial name
- NCT02212899
- Where
- 4 sites in United States
- Volunteers
- 93 people
- Sponsor
- Mazor Robotics
Degenerative Disc Disease (DDD), Spinal Stenosis
PMCF Study on the Effectiveness and Safety of METROSAN Spinal Systems and BONEGRAFT Filling Materials
This is a prospective, multi-center, observational Post-Market Clinical Follow-Up (PMCF) study designed to collect additional safety and clinical performance data on CE-marked Titania® spinal instrumentation and fusion systems…
- Conditions
- Degenerative Disc Disease (DDD), Spinal Stenosis, Spondylolisthesis, Spinal Deformities
- Trial name
- INFO SPINE (NCT07615491)
- Testing
- Titania® Cervical Interbody Fusion Cage (Titanium), Titania® Cervical Interbody Fusion Cage (PEEK), Titania® Posterior Cervical Stabilization System
- Where
- 3 sites in Turkey (Türkiye)
- Volunteers
- 561 people
- Sponsor
- Metrosan End. ve Elk. Mek. Cihazlar ve Tibbi Malz. San. Tic. Ltd. Co.