Clinical trials: Orthopedic Disorder of Spine
Intervertebral Disk Degeneration
An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
The aim of this trial is to evaluate if P-15 bone putty (investigational device) is not inferior in effectiveness and safety to local autologous bone (control device) when applied in instrumented anterior cervical discectomy and…
- Trial name
- NCT00310440
- Testing
- P-15 Synthetic osteoconductive bone substitute, Autologous bone
- Where
- 12 sites in United States, Canada
- Volunteers
- 319 people
- Sponsor
- CeraPedics, Inc
Lumbar Osteoarthritis, Spondylosis
Post-op Acetaminophen vs NSAID Use on Lumbar Spinal Fusion Outcomes
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively.
- Conditions
- Lumbar Osteoarthritis, Spondylosis, Lumbar Disc Disease, Spinal Stenosis
- Trial name
- NCT02700451
- Testing
- Ketorolac, Acetaminophen
- Where
- United States
- Volunteers
- 178 people
- Sponsor
- Hospital for Special Surgery, New York
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
Degenerative Disc Disease
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease…
- Trial name
- NCT02068768
- Testing
- Avenue® L Interbody Fusion System (LDR Spine)
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- LDR Spine USA
Pain, Opioid Use
Comparison of Quadratus Lumborum Block Types
This study will compare the quality of analgesia and reduction of opioid use, between standard of care and two groups of local anesthetic blocks in different location in the quadratus lumborum plane, for postoperative pain…
- Conditions
- Pain, Opioid Use, Lumbar Disc Herniation
- Trial name
- NCT04588389
- Testing
- Ropivacaine injection Location 1, Ropivacaine injection Location 2, Multimodal Pharmacological Management
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- University of Massachusetts, Worcester
Spondylolisthesis, Neurologic Deficits
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
The purpose of the Post-Market Surveillance study is to evaluate safety.
- Conditions
- Spondylolisthesis, Neurologic Deficits, Kyphosis, Pseudarthrosis
- Trial name
- DSS (NCT01461005)
- Testing
- Dynamic Stabilization System (DSS)
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Paradigm Spine
Degenerative Disc Disease, Trauma (Including Fractures)
BIO4 Clinical Case Study: Cervical Spine
The goal of this study is to investigate the efficacy of BIO4 bone matrix in patients undergoing 1 or 2-level Anterior Cervical Discectomy and Fusion (ACDF) spine surgery.
- Conditions
- Degenerative Disc Disease, Trauma (Including Fractures), Spondylolisthesis
- Trial name
- NCT03077204
- Testing
- 1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window)., Aviator Anterior Cervical Plating System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Seton Healthcare Family
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.
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
Degenerative Changes, Stenosis
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared…
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT01873586
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- SeaSpine, Inc.
Osteoporosis
PTH & Ibandronate Combination Study (PICS)
This study will test in several innovative ways, several different combinations of PTH and oral monthly ibandronate for the treatment of osteoporosis in postmenopausal women.
- Trial name
- PICS (NCT00683163)
- Testing
- PTH(1-84), Ibandronate
- Where
- United States
- Volunteers
- 44 people
- Sponsor
- University of California, San Francisco
Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis
Zoledronate or Observation in Maintaining Bone Mineral Density in Patients Who Are Undergoing Surgery to Remove Both Ovaries
This randomized phase II trial is studying zoledronate to see how well it works compared to observation in maintaining bone mineral density in patients who are undergoing surgery to remove both ovaries.
- Conditions
- Hereditary Breast and Ovarian Cancer Syndrome, Osteoporosis, Ovarian Carcinoma
- Trial name
- NCT00305695
- Testing
- Laboratory Biomarker Analysis, Zoledronic Acid
- Where
- 95 sites in United States
- Volunteers
- 160 people
- Sponsor
- Gynecologic Oncology Group
Anxiety, Depression
Optimizing Mental Health in Orthopedic Care
This study will utilize qualitative cross-sectional and quantitative longitudinal methods. In semi-structured interviews, orthopedic providers and patients with spine conditions will discuss their overall perspectives, specific…
- Conditions
- Anxiety, Depression, Back Pain, Neck Pain
- Trial name
- NCT05194722
- Testing
- Wysa mobile app
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Washington University School of Medicine
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.
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
Osteoporosis, Osteoporosis, Age-Related
Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)
A 12-month study to measure the efficacy and safety of abaloparatide in men with osteoporosis.
- Conditions
- Osteoporosis, Osteoporosis, Age-Related, Osteoporosis Localized to Spine, Age Related Osteoporosis
- Trial name
- NCT03512262
- Testing
- Abaloparatide
- Where
- 34 sites in United States, Italy and 1 more
- Volunteers
- 228 people
- Sponsor
- Radius Health, Inc.
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative…
- Trial name
- NCT02104167
- Testing
- ROIC interbody cage with VerteBRIDGE plating
- Where
- 7 sites in United States
- Volunteers
- 110 people
- Sponsor
- LDR Spine USA
Osteoporosis
Comparison of the Effects of 2 Drugs on Lumbar Spine Volumetric BMD in Men With Glucocorticoid-Induced Osteoporosis
The objective of this study is to test the hypothesis that teriparatide is superior to the active comparator in the change from baseline to 18 months of lumbar spine volumetric trabecular bone mineral density (BMD) in males with…
- Trial name
- EuroGIOPS (NCT00503399)
- Testing
- Teriparatide, Risedronate
- Where
- 13 sites in Germany, Greece and 2 more
- Volunteers
- 92 people
- Sponsor
- Eli Lilly and Company
Osteoporosis
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent…
- Trial name
- MOVE (NCT00887354)
- Testing
- Teriparatide, Risedronate, Calcium
- Where
- 28 sites in United States, Canada and 10 more
- Volunteers
- 224 people
- Sponsor
- Eli Lilly and Company