Clinical trials: Spinal (Fusion) Surgery
Cervical Degenerative Disc Disease
Comparison of DISCOVER™ Artificial Cervical Disc and ACDF for Treatment of Cervical DDD (IDE Study)
This study is intended to treat patients with symptomatic degenerative disc disease at one level of the cervical spine. The patients will be randomized to the DISCOVER Artificial Cervical Disc (total disc replacement) or…
- Trial name
- NCT00432159
- Testing
- Cervical TDR, ACDF with plate
- Where
- 32 sites in United States, Australia and 1 more
- Volunteers
- 500 people
- Sponsor
- DePuy Spine
Pain, Postoperative
Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients
Methadone has several advantages over standard narcotic medications, especially when considering use after a typically painful surgery such as lumbar fusion.
- Trial name
- MAPS (NCT02989597)
- Testing
- Methadone Hydrochloride, Standard pain regimen, Spinal Fusion Surgery
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Staphylococcal Vaccine
Safety and Efficacy of SA4Ag Vaccine in Adults Having Elective Open Posterior Spinal Fusion Procedures With Multilevel Instrumentation
The purposes of the clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery, and to evaluate the safety of…
- Trial name
- STRIVE (NCT02388165)
- Testing
- Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine
- Where
- 301 sites in United States, Austria and 9 more
- Volunteers
- 3,450 people
- Sponsor
- Pfizer
Spinal Fusion, Cardiopulmonary Bypass
Point of Care Testing in Pediatric Patients Undergoing Major Surgery
The current study proposes to investigate Point of Care Testing (POCT) (Coagcheck®) and compare obtained results versus standard laboratory coagulation parameters prothrombin time (PT) and partial thromboplastin time (PTT).
- Trial name
- NCT01742936
- Testing
- CoaguChek, Hospital Laboratory
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Nationwide Children's Hospital
Curvature of Spine
The Use of Tranexamic Acid to Reduce Perioperative Blood Loss During High Risk Spine Fusion Surgery
The purpose of this study is to determine if tranexamic acid reduces perioperative blood loss and red blood cell transfusion during high risk spine surgery.
- Trial name
- TXA (NCT01728636)
- Testing
- Tranexamic Acid
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Northwestern University
Diabetes, Cervical Myelopathy
Diabetes and Glycosylation in Cervical Spondylosis
The purpose of this study is to determine the relevant significance of diabetes on cervical disc degeneration, and correlate diabetic control (HgbA1C) with disc glycosylation profile in patients undergoing anterior cervical…
- Conditions
- Diabetes, Cervical Myelopathy, Cervical Spondylosis
- Trial name
- NCT02758899
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Washington University School of Medicine
Cervical Spondylosis With Myelopathy
Cervical Spondylotic Myelopathy Surgical Trial
The purpose of the study is to determine the optimal surgical approach (ventral vs dorsal) for patients with multi-level cervical spondylotic myelopathy (CSM).
- Trial name
- NCT02076113
- Testing
- Ventral (Front) decompression with Fusion, Dorsal (Back) Decompression with Fusion, Dorsal (back) Laminoplasty
- Where
- 16 sites in United States, Canada
- Volunteers
- 269 people
- Sponsor
- Lahey Clinic
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.
Pain, Postoperative, Postoperative Nausea and Vomiting
Comparison of Two Naloxone Infusion Rates on the Postoperative Recovery of Patients Undergoing Spine Fusion Surgery
There will be two groups in this study: one group will be given the standard infusion of naloxone, a drug which helps reduce side effects from opioids needed after surgery, and the other group will receive a higher dose.
- Conditions
- Pain, Postoperative, Postoperative Nausea and Vomiting, Scoliosis
- Trial name
- NCT01531439
- Testing
- Naloxone
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Children's Mercy Hospital Kansas City
Lumbar Spinal Stenosis, Spondylolisthesis
Sagittal Plane Shear Index for Planning Lumbar Stenosis Surgery
The objective of the clinical investigation is to assess the proportion of lumbar spinal stenosis surgical treatment plans that change when an objective measurement of spinal stability is included and applied following a simple…
- Trial name
- SPSI (NCT03754972)
- Testing
- Sagittal plane shear index (SPSI)
- Where
- 3 sites in Netherlands
- Volunteers
- 100 people
- Sponsor
- Medical Metrics Diagnostics, Inc
Spinal Fusion
Evaluating the Role of Pregabalin in Reducing Opioid Requirement in Spinal Fusion Surgeries of Two or More Vertebrae
To see if the administration of 3 dosses of pregabalin (1 dose preoperative, 2 doses postoperative) will reduce the postoperative opiate requirements of patients undergoing spinal fusion surgeries of two or more vertebrae.
- Trial name
- NCT03031340
- Testing
- Pregabalin
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Montefiore Medical Center
Spinal Fusion
Efficacy and Safety of Tranexamic Acid in Spinal Fusion Surgery
The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.
- Trial name
- NCT03425799
- Testing
- Sodium Chloride 0.9% Inj, Tranexamic Acid
- Where
- 4 sites in United States
- Volunteers
- 5 people
- Sponsor
- Exela Pharma Sciences, LLC.
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
Failed Back Surgery Syndrome, Pain
Spinal Cord Stimulation With Precision® System Versus Reoperation for Failed Back Surgery Syndrome
The EVIDENCE trial is a randomized controlled trial comparing the therapeutic effectiveness and cost-effectiveness of the Precision® Spinal Cord Stimulation with that of reoperation as a treatment of pain in patients with Failed…
- Conditions
- Failed Back Surgery Syndrome, Pain, Back Pain
- Trial name
- Evidence (NCT01036529)
- Testing
- Precision Spinal Cord Stimulator, Back Surgery
- Where
- 18 sites in United States, Canada and 2 more
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Boston Scientific Corporation
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
Systemic Lidocaine Improves Pain Control After Surgery by Attenuating the Systemic Inflammatory Response to Surgery
IV Lidocaine in Pediatric AIS
This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid…
- Trial name
- PEDS LIDO (NCT03893318)
- Testing
- IV lidocaine
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Washington University School of Medicine
Spine Disease, Spine Degeneration
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
One of the primary goals of spine surgery is to reduce pain and increase mobility to improve patients' quality of life. Currently, there is no established method for surgeons to objectively track their patients' mobilization…
- Conditions
- Spine Disease, Spine Degeneration, Spinal Stenosis, Surgery
- Trial name
- NCT04379921
- Testing
- Apple Watch and App
- Where
- United States
- Volunteers
- 255 people
- Sponsor
- Stanford University
Idiopathic Scoliosis
Methadone vs Magnesium in Spinal Fusion
Significant pain may occur following posterior spinal fusion despite the use of conventionally accepted techniques including patient controlled analgesia.
- Trial name
- NCT01795495
- Testing
- Methadone hydrochloride, Magnesium Sulfate, Remifentanil
- Where
- United States
- Volunteers
- 63 people
- Sponsor
- Nationwide Children's Hospital
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