Clinical trials: Spine Surgery
Low Back Pain
TissueLink Study During Multi-Level Spine Surgery
The overall objective of the investigators research is to test the clinical efficacy of the TissueLink™ (Salient Surgical Technologies, Inc.) coagulation system in minimizing hemoglobin loss intraoperatively.
- Trial name
- NCT01300559
- Testing
- Tissuelink device
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Duke University
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.
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.
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Melanoma, Metastatic Malignant Neoplasm in the Spine
Adaptive Staged Stereotactic Body Radiation Therapy in Treating Patients With Spinal Metastases That Cannot Be Removed by Surgery
This pilot clinical trial studies adaptive staged stereotactic body radiation therapy (SBRT) in treating patients with spinal metastases that cannot be removed by surgery.
- Conditions
- Melanoma, Metastatic Malignant Neoplasm in the Spine, Renal Cell Carcinoma, Soft Tissue Sarcoma
- Trial name
- NCT02527304
- Testing
- Image-Guided Adaptive Radiation Therapy, Quality-of-Life Assessment, Questionnaire Administration
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Albert Einstein College of Medicine
Surgical Wound Infection
Topical Antibiotic Treatment for Spine Surgical Site Infection
There is considerable interest in using in-wound antibiotics (IWA) to prevent infection after spine surgery. An adequate evaluation of IWA is lacking and prior studies are limited by confounding and bias.
- Trial name
- NCT02776774
- Where
- United States
- Volunteers
- 91 people
- Sponsor
- University of Washington
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
Spine Surgery, Wounds Vac
Prophylactic Application of an Incisional Wound Vac to Prevent Wound Complications in Obese Spine Surgery Patients
This is a prospective randomized study evaluating the use of a prophylactic incision wound vac dressing, applied in the OR, on patients undergoing posterior spine surgery with a BMI>35.
- Trial name
- NCT02926924
- Testing
- Wound Vac, Standard Dressing
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- University of Michigan
Spine Surgery
Perioperative Intravenous Lidocaine or Epidural Anesthesia on Outcomes in Complex Spine Surgery
The purpose of this study is determine if epidural anesthesia administered after surgery or lidocaine administered during surgery will decrease inflammation after spinal surgery and decrease the need for post operative pain…
- Trial name
- NCT00840996
- Testing
- Lidocaine
- Where
- United States
- Volunteers
- 116 people
- Sponsor
- The Cleveland Clinic
Pain, Postoperative, Spine Injuries and Disorders
An Analysis of the Efficacy of a Pre-Emptive Multimodal Pain Regimen in Reducing Acute Post-Operative Pain and Narcotic Pain Medication Requirements in Spine Surgery
The aim of this study is to investigate the hypothesis that multimodal pain regimen (consisting of acetaminophen, celecoxib, gabapentin, and oxycodone) administered pre-operatively before elective spine surgery significantly…
- Conditions
- Pain, Postoperative, Spine Injuries and Disorders, Narcotic Use
- Trial name
- NCT04522206
- Testing
- Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- NYU Langone Health
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
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
Digital Block
Comparison of Three Methods of Hemoglobin Monitoring
This study will further investigate the Masimo SpHb [FDA Approved] continuous non-invasive hemoglobin monitor in spine surgery patients.
- Trial name
- NCT01284296
- Testing
- Lidocaine digital block, Masimo SpHb continuous hemoglobin monitor
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Francisco
Low Back Pain, Opiate Addiction
Study of Opioid Use After Lumbar and Cervical Spine Surgery
The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery.
- Conditions
- Low Back Pain, Opiate Addiction, Neck Pain
- Trial name
- SOULCS (NCT02674711)
- Testing
- Educational Video
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Brooke Army Medical Center
Lumbar Spine Surgery
Safety and Efficacy of DepoDur in Lumbar Spine Surgery Patients
The purpose of the study is to help determine the appropriate dose of DepoDur for use in spinal surgery. The study will also assess the safety of this drug in this patient population.
- Trial name
- DepoDur (NCT00335517)
- Testing
- DepoDur
- Where
- United States
- Volunteers
- 98 people
- Sponsor
- University of Rochester
Surgical Blood Loss, Spinal Surgery
Efficacy of Suction Enabled Retraction Device
This is a prospective randomized controlled trial of the Suction-Integrated Surgical Tissue Elevator \& Retractor [SISTER] device to assess: Effects on operative time and efficiency of exposure in open lumbar spine cases.
- Trial name
- NCT03160170
- Testing
- SISTER device
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University of Miami
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
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
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
Opioid Withdrawal
Lofexidine for Adults Undergoing Lumbar Spine Surgery
The primary objective is to investigate the effects of lofexidine in adults undergoing opioid tapering prior to elective lumbar spine surgery.
- Trial name
- NCT04126083
- Testing
- Lofexidine Oral Tablet
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Mayo Clinic