Clinical trials: Spine Surgeries
Spine Surgery, Rotational Thrombo-elastometry (ROTEM)
Effectiveness of ROTEM-based Coagulation Surveillance on Reducing Blood Product Utilization During Complex Spine Surgery
The Purpose of this study is to identify added value of Rotational thrombo-elastometry (ROTEM) intra-operative coagulation surveillance on reducing blood product use during major reconstructive spine surgery.
- Trial name
- NCT02758184
- Testing
- ROTEM-based coagulation monitoring, Spine surgery
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Duke University
Posterior Spine Surgery
Evaluation of Spine Surgery Analgesic Pathway
Investigators plan to study the role of spine surgery analgesic pathways - for procedures with high risk of postoperative pain - in improving the quality of recovery
- Trial name
- NCT02887404
- Testing
- Spine surgery analgesic pathway, Usual Care
- Where
- United States
- Volunteers
- 299 people
- Sponsor
- The Cleveland Clinic
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
Low Back Pain, Lumbosacral Radiculopathy
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of…
- Conditions
- Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation
- Trial name
- NCT03514277
- Testing
- Exparel, Bupivacaine
- Where
- United States
- Volunteers
- 19 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Spine Surgery, Reversal of Neuromuscular Blockade
Sugammadex vs Neostigmine/Glycopyrrolate on Urinary Retention After Spine Surgery
This is an active-comparator controlled study to evaluate the effect of sugammadex compared to neostigmine/glycopyrrolate for reversal of rocuronium on the incidence of urinary retention after subjects undergo elective ambulatory…
- Conditions
- Spine Surgery, Reversal of Neuromuscular Blockade, Urinary Retention Postoperative
- Trial name
- NCT05887375
- Testing
- Sugammadex, Neostigmine, Glycopyrrolate
- Where
- United States
- Volunteers
- 118 people
- Sponsor
- University of Missouri-Columbia
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
Blood Loss, Surgical
Evaluation of Thromboelastometry (ROTEM) During Spinal Surgery
The purpose of this study is to determine whether the use of ROTEM, during spinal surgery is effective on diminishing the total blood loss and the risk of Allogenic Transfusion of Blood Products vs control cases without ROTEM…
- Trial name
- ROTEM_SPINE (NCT02740374)
- Testing
- ROTEM, Standard of Care
- Volunteers
- 112 people
- Sponsor
- Ohio State University
Surgical Site Infection
Bacterial Contamination: Iodine vs Saline Irrigation in Pediatric Spine Surgery
This study will evaluate the safety of povidone-iodine irrigation in pediatric spinal patients by collecting pre- and post-operative safety labwork.
- Trial name
- NCT02527512
- Testing
- Povidone-Iodine, Normal Saline
- Where
- 2 sites in United States
- Volunteers
- 173 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Surgery
Device to Reduce Surgery Site Contamination - Spine
The objective of this study is to determine whether the Air Barrier System device reduces airborne colony-forming units (e.g. bacteria) present at a surgery site during spinal procedures.
- Trial name
- NCT01262105
- Testing
- Air Barrier System Device
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Nimbic Systems, LLC
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
Pain
Perioperative Pain Management In Spine Surgery Patients: Part I
The purpose of this study is a comparison of pain management in opioid-tolerant spine surgery patients using a perioperative dosing goal of 150% of patient's baseline oral morphine equivalent (OME), as compared to standard…
- Trial name
- NCT01447888
- Testing
- 150% Oral Morphine Equivalent (OME), Clinical Judgment
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Allina Health System
Lumbar Spine Surgeries, Cervical Spine Surgeries
Impact of Surgical Theater's Patient Engagement
To evaluate usefulness of Surgical Theater's Patient Engagement 360VR platform in helping align patient expectations and improve patient satisfaction and understanding in spinal surgery consults.
- Trial name
- ISTPE (NCT05334212)
- Testing
- Surgical Theater
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- University Hospitals Cleveland Medical Center
Symptomatic Cervical Disc Disease
Safety and Efficacy Study Comparing ProDisc-C to ACDF Surgery to Treat SCDD
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc-C to anterior cervical discectomy and fusion (ACDF) surgery in the treatment of symptomatic cervical disc disease (SCDD).
- Trial name
- NCT00291018
- Testing
- Total Disc Replacement, ACDF
- Volunteers
- 368 people
- Sponsor
- Synthes USA HQ, Inc.
Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma
Testing Whether Treating Breast Cancer Metastases With Surgery or High-Dose Radiation Improves Survival
This randomized phase II/III trial studies how well standard of care therapy with stereotactic radiosurgery and/or surgery works and compares it to standard of care therapy alone in treating patients with breast cancer that has…
- Conditions
- Anatomic Stage IV Breast Cancer American Joint Committee on Cancer (AJCC) v8, Metastatic Breast Carcinoma, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Liver
- Trial name
- NCT02364557
- Testing
- Stereotactic Body Radiotherapy, Surgery
- Where
- 162 sites in United States, Canada and 2 more
- Volunteers
- 129 people
- Sponsor
- NRG Oncology
Spinal Diseases
Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery
The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine.
- Trial name
- PDL (NCT00295009)
- Testing
- ProDisc, Spinal Fusion
- Volunteers
- 852 people
- Sponsor
- Synthes USA HQ, Inc.