Clinical trials: Spine
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
Lumbar Spinal Stenosis, Thoracic Spinal Stenosis
Effectiveness Study of the Drug Tranexamic Acid to Reduce Post-surgery Blood Loss in Spinal Surgery
Hypothesis: Topical application of Tranexamic acid into the surgical wound during spine surgery will decrease the overall blood loss post-operatively. This reduction in blood loss will reduce the need for transfusion.
- Trial name
- NCT02063035
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Massachusetts General Hospital
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
Degenerative Disc Disease
LDR Spine USA Mobi-C(R) Cervical Disc Prosthesis IDE
The purpose of this investigation is to establish the safety and effectiveness of the LDR Spine Mobi-C® Cervical Disc Prosthesis which is an anterior cervical interbody mechanical device.
- Trial name
- NCT00389597
- Testing
- Cervical Artificial Disc
- Where
- 24 sites in United States
- Volunteers
- 599 people
- Sponsor
- LDR Spine USA
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
Spinal Cord Compression Due to Metastasis to Spine
High-precision Radiotherapy of Motor Deficits Due to Metastatic Spinal Cord Compression
The major goal of this clinical study is to investigate to which extent high-precision radiotherapy (RT) with modern techniques can prevent progression or recurrence of motor deficits (weakness) of the legs following RT.
- Trial name
- PRE-MODE (NCT03070431)
- Testing
- High-precision RT 5x5 Gy in 1 week
- Where
- Germany
- Volunteers
- 44 people
- Sponsor
- University Hospital Schleswig-Holstein
Degenerative Disc Disease, Grade 1 Spondylolisthesis
Comparison of Complication Rates Between Lateral Approaches to the Lumbar Spine
An evaluation of the incidence of complications resulting from far lateral spine surgery utilizing the K2M RAVINE® Lateral Access System (RAVINE) with ALEUTIAN® Lateral Interbody Spacer System versus literature reported results…
- Trial name
- RAVINE (NCT02068729)
- Volunteers
- 131 people
- Sponsor
- K2M, Inc.
Trauma, Opioid Use
Relieving Acute Pain (RAP) Study: A Pilot Study
The United States (US) faces a crisis of pain management. According to the 2012 National Health Interview Survey, almost 50 million adults in the US reported having significant chronic or severe pain (Nahin 2015).
- Conditions
- Trauma, Opioid Use, Spine Fusion
- Trial name
- NCT03426137
- Testing
- Oxycodone, Ketorolac
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of Maryland, Baltimore
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level…
- Trial name
- NCT02104141
- Testing
- ROIA Interbody Cage with VerteBRIDGE plating
- Volunteers
- 51 people
- Sponsor
- LDR Spine USA
Chronic Low-back Pain, Postsurgical Pain
Postoperative Telehealth Mindfulness Intervention After Spine Surgery
Lumbar spine pain is the leading cause of years lived with a disability and affects over 50 million individuals in the United States.
- Conditions
- Chronic Low-back Pain, Postsurgical Pain, Opioid Use, Lumbar Spine Surgery
- Trial name
- NCT04648683
- Testing
- Individual telehealth mindfulness, Group telehealth mindfulness
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Vanderbilt University Medical Center
Cervical Radiculopathy
Dispersal Pattern for Spine Injections (Gadolinium Contrast)
This study will analyze injectate dispersal patterns after standard-of-care cervical epidural steroid injections using gadolinium as a marker and magnetic resonance imaging (MRI) to characterize the pattern.
- Trial name
- NCT02217280
- Testing
- Injection with Gadolinium
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Missouri-Columbia
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
Lumbar Spine Stenosis Central Canal
Comparative Study of Sham Versus Mild® Procedure in Patients Diagnosed With Symptomatic Lumbar Central Canal Stenosis
This is a single-center, randomized, prospective, double-blind, clinical study to assess the clinical application and outcomes with mild® devices versus sham in patients with symptomatic moderate to severe central canal spinal…
- Trial name
- NCT01129921
- Testing
- Percutaneous Lumbar Decompression
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Napa Pain Institute
Ileus, Fusion of Spine
The Use of Oral Naloxone to Prevent Post Spinal Fusion Ileus
Postoperative ileus and opioid induced constipation are well-known post-operative complications. Previously, research has shown that using peripherally acting opioid antagonists can help alleviate the condition.
- Trial name
- FusionIleus (NCT03176316)
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Loyola University
Intervertebral Disc Degeneration
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient.
- Trial name
- Duloxetine (NCT02535000)
- Testing
- Duloxetine
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Serviço de Anestesiologia de Joinville
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 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
Degenerative Disc Disease, Spondylolisthesis, Grade 1
AccuLIF® PROSPECTIVE PATIENT OUTCOMES STUDY
This is a post-market clinical study of the AccuLIF expandable transforaminal lumbar interbody fusion (TLIF) cage in patients requiring surgery for degenerative disc disease (DDD) with up to Grade I spondylolisthesis or…
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Grade 1, Retrolisthesis
- Trial name
- APROPOS (NCT02704689)
- Testing
- AccuLIF expandable TLIF cage
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- VB Spine, LLC
Spinal Metastases
Stereotactic Radiosurgery (SRS) for Spine Metastases
This study will evaluate the most effective radiation dose. Patients will be randomized (like flipping a coin) to receive either low dose stereotactic radiotherapy (defined as "14 Gy") or high dose stereotactic radiotherapy…
- Trial name
- SRS (NCT00593320)
- Testing
- Stereotactic Radiosurgery
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Washington University School of Medicine
Evoked Potentials, Visual
A Novel Method for Capturing the Visual Evoked Potential During Spine Surgery Under Total Intravenous Anesthesia
Spine surgery in the prone position (which involves lying face down) is associated with various visual changes, ranging from temporary changes in acuity (or sharpness) to permanent blindness.
- Trial name
- VEP (NCT02563028)
- Testing
- SightSaver Visual Stimulator
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Hospital for Special Surgery, New York