Clinical trials: Spine Surgery
Degenerative Disc Disease
Study of an Expandable Interbody Device for the Lumbar Spine
The primary objective of this study is to evaluate the safety and efficacy of CALIBER expandable spacer for the treatment of degenerative disc disease.
- Trial name
- CALIBER (NCT02075554)
- Testing
- CALIBER
- Where
- 2 sites in United States
- Volunteers
- 58 people
- Sponsor
- Globus Medical Inc
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
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
Pain, Postoperative
Safety and Efficacy Study of Fentanyl Iontophoretic Transdermal System (ITS) for Management of Moderate to Severe Acute Pain in Participants Who Have Undergone Elective Spine or Orthopedic Surgery
The purpose of this study is to evaluate in daily clinical practice the safety and efficacy of fentanyl Iontophoretic Transdermal (through the skin) System (ITS) for management of moderate (medium level of seriousness) to severe…
- Trial name
- NCT00779038
- Testing
- Fentanyl ITS
- Where
- 3 sites in Belgium
- Volunteers
- 13 people
- Sponsor
- Janssen Cilag N.V./S.A.
Spine Surgery
Comprehensive Spinal Alignment Planning Study
A comprehensive approach to the evaluation of alignment in spinal surgery patients - through preoperative planning, intraoperative assessment, and postoperative confirmation - has not been well-studied.
- Trial name
- NCT02606695
- Testing
- NuvaMap O.R., NuvaMap
- Where
- 15 sites in United States
- Volunteers
- 306 people
- Sponsor
- NuVasive
Chronic Back Pain
SCS Programming Study in Treating Intractable Chronic Back Pain (NOVA)
This is an open-label prospective, randomized, controlled, multi-center study comparing DTM-SCS programming approach to Conventional SCS programming approach.
- Trial name
- NOVA (NCT04571242)
- Testing
- DTM Programming, Conventional SCS programming
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- SGX Nova LLC
Spinal Surgery of Vertebrae, Intervertebral Discs and the Spinal Cord, CT Scans
Automatic Optical Identification of the Spine Vertebrate Using Three-dimensional Optical Detection Based on a CT Test
CT scans of the spine include vertebrae, intervertebral discs and the spinal cord. These tests are performed in an orderly protocol and allow for three-dimensional reconstruction of the vertebra in sagittal and coronal guides.
- Trial name
- NCT04914585
- Where
- Israel
- Volunteers
- 200 people
- Sponsor
- Deep Health Ltd.
Herniation, Disc
Clinical Study to Evaluate the Anti-adhesion Efficacy and Safety of MegaShield®-SP in Comparison With Guardix-SP Plus After Spine Surgery
This study is Interventional, Parallel, Double-blinded, Randomized study. Subjects aged 20 to 70 years who had a Lumbar discectomy or laminectomy, MegaShield-SP® and Guardix-SP Plus will be applied.
- Trial name
- NCT06369233
- Testing
- MegaShield®-SP, Guardix-SP Plus
- Where
- 4 sites in South Korea
- Volunteers
- 80 people
- Sponsor
- L&C Bio
Scoliosis Idiopathic
PMCF (Post-Market Clinical Follow-up) Study on The Tether™ in UK (United Kingdom)
The goal of this observational study is to collect information about The Tether™ device in participants with progressive idiopathic scoliosis, Lenke Type 1 curves.
- Trial name
- NCT05830825
- Testing
- Vertebral Body Tethering (VBT)
- Where
- 3 sites in United Kingdom
- Volunteers
- 100 people
- Sponsor
- LDR Médical SAS
Spine Surgery
An Open, Parallel-group, Randomized, Medical Device Study to Assess the Usability and Performance of Surgify HaloTM in Spine Surgery Versus State-of-art (Rosen Burr)
The purpose of this research study is to: test the usability and performance of the medical device Surgify Halo ™ in spine surgery test the level of "chattering " during the use of the device test the cutting performance of…
- Trial name
- NCT06827795
- Testing
- A burr used in spine surgery
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Surgify Medical Oy
Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders
Spine Surgery for Adhesions in Patients Evaluated for Efficacy and Safety of MedicurtainⓇ (Pivotal Study)
This study was designed to evaluate the efficacy and safety of Medicurtain®, an antiadhesion barrier in patients who underwent In Situ Decompression for single level and unilateral herniated lumbar intervertebral disc.
- Conditions
- Intervertebral Disc Disorder, Thoracic Intervertebral Disc Disorders, Thoracolumbar Intervertebral Disc Disorders, Lumbosacral Intervertebral Disc Disorders
- Trial name
- NCT04688281
- Testing
- Medicurtain®, GUARDIX-SG®
- Where
- South Korea
- Volunteers
- 87 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
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 Spinal Stenosis
The Vertos MILD™ Preliminary Patient Evaluation Study
This is a single-center, open label, prospective clinical study to assess the clinical application and functional outcomes of symptomatic patients undergoing the Minimally Invasive Lumbar Decompression (MILD™) treatment for…
- Trial name
- NCT00749073
- Testing
- Minimally Invasive Lumbar Decompression (MILD™)
- Where
- Canada
- Volunteers
- 10 people
- Sponsor
- Vertos Medical, Inc.
Vertebral Fracture, Compression Fracture
Spine Bone Cements Outcomes - Post Market Follow-up
A Post-Market Clinical Follow-Up (PMCF) Study to collect clinical data on safety and performance of all TEKNIMED Spine range of products: SPINEFIX, HIGH V+, OPACITY+ and F20 bone cements and mixing and injection systems, and all…
- Conditions
- Vertebral Fracture, Compression Fracture, Osteoporotic Fractures
- Trial name
- NCT06367582
- Testing
- Vertebroplasty (VP), Kyphoplasty (KP), Pedicular Screw Augmentation (PSA)
- Where
- 12 sites in France, Portugal and 2 more
- Volunteers
- 500 people
- Sponsor
- Teknimed
Symptomatic Cervical Disc Disease
2-level Cervical Disc Replacement Comparing Prodisc C SK & Vivo to Mobi-C
A multi-center, prospective, randomized, controlled comparison of the prodisc C SK and prodisc C Vivo to the control, a similar, legally marketed total disc replacement device in subjects with symptomatic cervical disc disease…
- Trial name
- SMART (NCT04012996)
- Testing
- prodisc C SK and/or Vivo, Mobi-C Cervical Disc
- Where
- 30 sites in United States
- Volunteers
- 390 people, healthy volunteers welcome
- Sponsor
- Centinel Spine
Spinal Fusion, Deformity of Spine
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
PAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
- Trial name
- PAULA (NCT05640908)
- Testing
- iFuse Bedrock Granite Implant System
- Where
- 9 sites in United States
- Volunteers
- 200 people
- Sponsor
- SI-BONE, Inc.
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
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Spine Fusion, Spinal Deformity
Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of…
- Trial name
- NCT05001893
- Testing
- S53P4 bioactive glass putty
- Where
- Finland
- Volunteers
- 500 people
- Sponsor
- Bonalive Biomaterials Ltd
Intraoperative Monitoring, Spinal Diseases
Intraoperative Monitoring (IOM) Patient Registry
The primary objective of this study is to evaluate the rate of new or worsening neurologic deficits and/or radiculopathy following lumbar or cervical surgery in light of IOM using neurological testing (motor and sensory) in the…
- Trial name
- IOM (NCT02187653)
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- DC2 Healthcare