Clinical trials: Spine Surgeries
Ischemic Optic Neuropathy
Safety and Efficacy of Using SightSaver Visual Evoked Potential (VEP) for VEP Monitoring in Prone Spine Surgery
Post-operative visual loss (POVL) following non-ocular surgical procedures is an infrequent but severe complication. Little is understood about this complication, but most cases seem to result from loss of blood flow to the optic…
- Trial name
- SightSaver (NCT02643615)
- Testing
- VEP under TIVA, VEP under balanced anesth., Propofol
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ohio State University
Spinal Surgery, Vascular Surgery
Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis
The purpose of this study is to evaluate the safety and immune system response to recombinant thrombin when used to control bleeding in spinal and vascular surgery.
- Trial name
- NCT00491608
- Testing
- rThrombin
- Where
- United States
- Volunteers
- 234 people
- Sponsor
- ZymoGenetics
Lumbar Spine Injury
The Use of Dantrolene to Improve Analgesia in Posterior Lumbar Surgery
The purpose of this study is to determine whether administration of a non-centrally acting muscle relaxants will improve the Overall Benefit of Analgesia Score (OBAS), and Richmond Agitation Sedation Scale (RASS) scores in…
- Trial name
- NCT03762109
- Testing
- Dantrolene
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- Beth Israel Deaconess Medical Center
Pain, Intractable, Pain, Chronic
Comparison of DTM™ SCS Therapy Combined With Conventional Medical Management (CMM) to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Spine Surgery
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic…
- Trial name
- NCT06442410
- Testing
- DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system, Conventional Medical Management (CMM)
- Where
- 12 sites in Belgium, Germany and 2 more
- Volunteers
- 115 people
- Sponsor
- MedtronicNeuro
Posterior Cervical Decompression and Fusion
A Randomized Controlled Crossover Study Comparing Sugammadex and Placebo
Intraoperative monitoring of the motor evoked potentials has been shown to be both a sensitive and specific indicator for detecting intraoperative neurological injuries during spine surgery.(Fehlings, Brodke et al.
- Trial name
- NCT03087513
- Testing
- Sugammadex Injection [Bridion]
- Where
- Canada
- Volunteers
- 40 people
- Sponsor
- University Health Network, Toronto
Surgical Sponge, Retained
Intraoperative Radiographic Detection of Retained Surgical Sponges
This prospective study will determine the efficacy of intraoperative x-ray to identify retained surgical sponges. The recommended practice for finding a retained sponge is by radiography.
- Trial name
- NCT04097678
- Testing
- Retained Surgical Sponge
- Where
- United States
- Volunteers
- 146 people
- Sponsor
- Twin Cities Spine Center
Post-operative Urinary Retention
Decreasing Rates of Intraurethral Catheterization Postoperatively in Spine Surgery
Randomization (1:1) of male patients, over age 50, undergoing elective spine surgery to tamsulosin versus a placebo.
- Trial name
- DRIPS (NCT02919436)
- Testing
- Tamsulosin
- Where
- United States
- Volunteers
- 610 people
- Sponsor
- Anand Rughani, MD
Post-laminectomy Pain Syndrome
GRASSP: Gralise® for Spine Surgery Pain
Evaluate the analgesic benefit of Gralise® for post-laminectomy pain syndrome (PLPS)
- Trial name
- GRASSP (NCT01764464)
- Testing
- Gralise®
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- University of Rochester
Surgery, Anesthesia
Endotracheal Tube Holder and Bite Guard Research
This study aims to test the effectiveness of a novel combined endotracheal tube holder and bite guard when compared with the current standard of care, tape and an oral airway.
- Trial name
- NCT02347488
- Testing
- Haider ETT Tube Holder and Bite Guard, Tape
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, Los Angeles
Infection, Spinal Injuries
The Value of Home Chlorhexidine Pre-Surgical Wash Before Spine Surgery
The study team hypothesizes that at-home cleansing of the surgical site with chlorhexidine wipes provide no added benefit to decreasing microbial activity or preventing surgical site infections.
- Trial name
- NCT02767427
- Testing
- Chlorhexidine Wipes, No intervention
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Columbia University
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
Opioid Use, Pain, Postoperative
Erector Spinae Plane Block Versus Conventional Analgesia in Complex Spine Surgery
Enhanced recovery pathways (ERPs) emphasize evidence-based, multimodal anesthetic and analgesic choices to minimize opioid consumption while providing adequate pain control after surgery.
- Trial name
- ESPB-Spine (NCT04156581)
- Testing
- Bupivacaine, Dexamethasone, Saline
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Hospital for Special Surgery, New York
Spine Fusion, Pain, Postoperative
The Impact of Sublingual Sufentanil on Postoperative Pain and Analgesic Requirements in Spine Surgery Patients
In this study the investigators plan to examine the perioperative use of sufentanil sublingual (SL) in the analgesic regimen for spine surgery, one of the most common surgeries performed in the US.
- Conditions
- Spine Fusion, Pain, Postoperative, Opioid Use
- Trial name
- NCT04263909
- Testing
- Sublingual Tablet
- Where
- United States
- Volunteers
- 199 people
- Sponsor
- Brigham and Women's Hospital
Juvenile; Scoliosis, Scoliosis Idiopathic
Digital Health Psychosocial Intervention for Adolescent Spine Surgery Preparation and Recovery
This is a randomized controlled trial to test effectiveness of the SurgeryPal intervention vs. education control to improve acute and chronic pain and health outcomes in youth undergoing major musculoskeletal surgery.
- Conditions
- Juvenile; Scoliosis, Scoliosis Idiopathic, Scoliosis; Adolescence, Scoliosis;Congenital
- Trial name
- SurgeryPal (NCT04637802)
- Testing
- CBT (SurgeryPal), Education
- Where
- United States
- Volunteers
- 433 people
- Sponsor
- Seattle Children's Hospital
Spinal Stenosis, Lumbar Region, Spondylolisthesis
Evaluation of 3D Machine-vision Image Guided Surgery Spine Navigation
This study assesses clinical outcomes following the use of the MvIGS spine navigation system for treatment of spinal stenosis and degenerative spondylolisthesis of the lumbar spine in adults.
- Trial name
- NCT03968965
- Testing
- 3D MvIGS Spine Navigation, 2D Fluoroscopy
- Where
- United States
- Volunteers
- 64 people
- Sponsor
- 7D Surgical Inc.
Pain Control
A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair
The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
- Trial name
- NCT05552443
- Testing
- Hydromorphone 2.5 mcg/kg, Hydromorphone 2.75 mcg/kg, Hydromorphone 3 mcg/kg
- Where
- United States
- Volunteers
- 31 people
- Sponsor
- Mayo Clinic
Postoperative Delirium
Comparison of Postoperative Delirium in Patients Anaesthetised With Isoflurane and Desflurane During Spinal Surgery
Postoperative delirium (POD) is a known complication of inhalational agents used to anaesthetise patients for surgery with potential long term implications.The incidence of postoperative delirium in spine surgery is 3.3% to…
- Trial name
- NCT02925611
- Testing
- Isoflurane, Desflurane
- Where
- India
- Volunteers
- 60 people
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Lumbar Radiculopathy
Erector Spinae Block for Spine Surgery
This study is to determine whether or not the addition of liposomal bupivacaine in an ESP block will have long term benefits for patients undergoing lumbar spinal fusion surgery.
- Trial name
- NCT05417113
- Testing
- Liposomal bupivacaine, Bupivacaine
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Icahn School of Medicine at Mount Sinai
Bone Diseases, Spine Cancer
Custom Pack in Spine Surgery
Recent evidence suggests the efficacy of "custom pack" procedure on the operators reduction time and on the contamination risk due to the opening of many sterile packs.
- Conditions
- Bone Diseases, Spine Cancer, Spine Osteoarthritis
- Trial name
- kit (NCT03050203)
- Testing
- custom pack, standard care
- Where
- Italy
- Volunteers
- 37 people
- Sponsor
- Istituto Ortopedico Rizzoli
Low Back Disorder
MMG vs. EMG for Cortical Breach Detection
The purpose of this study is to determine how well mechanomyography (MMG) and electromyography (EMG) prevent cortical bone breaches, or the pinching of a nerve from screw placement, in patients having lower back surgery requiring…
- Trial name
- NCT05352048
- Testing
- Triggered Electromyography, Mechanomyography
- Where
- United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Francis Farhadi