Clinical trials: Spine Degeneration
Low Back Pain, Leg Pain
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis
The purpose of this multi-center, randomized, clinical study is to establish the safety and effectiveness of the TOPS™ System, used following decompression, in the treatment of lower back and leg pain with, or without spinal…
- Conditions
- Low Back Pain, Leg Pain, Spondylolisthesis, Lumbar Spinal Stenosis
- Trial name
- NCT00405691
- Testing
- "TOPS System" - Total Posterior Arthroplasty Implant
- Where
- 16 sites in United States
- Volunteers
- 450 people, healthy volunteers welcome
- Sponsor
- Impliant, Ltd.
Degenerative Spine Diseases, Surgical Wound
Effect of Topical Tranexamic Acid on Postoperative Drainage in Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI-TLIF)
The randomized controlled study which compare the efficacy outcomes (reducing blood loss and drainage output in patients) in patients undergoing single-level minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) and…
- Trial name
- NCT06427850
- Testing
- Tranexamic acid, Normal saline
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Thanawan Longsuwan
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
Treatment
Novel Technique Lumber Spine Fusion: Unilateral Pedicular Screws Fixation Combined With Contralateral Interbody Cage
● Null hypothesis (H0): Unilateral pedicle screw with contralateral interbody cage has better outcomes than unilateral pedicle screw fixation with ipsilateral cage.
- Trial name
- NCT05238662
- Testing
- pedicle screw fixation on one side and intervertebral cage on the other sided, pedicle screw fixation and interbody cage on the same side
- Volunteers
- 40 people
- Sponsor
- Zagazig University
Degenerative Disease of the Lumbosacral Spine
Transforaminal Lumbar Interbody Fusion (TLIF)
This is a global, multi-center, prospective, randomized, blinded, controlled pivotal study. Clinical and radiological evaluation will be performed preoperatively and postoperatively up to 24 months; and endpoint success will be…
- Trial name
- TLIF (NCT04073563)
- Testing
- Infuse™ Bone Graft (Infuse™), Intervertebral body fusion device and Medtronic posterior Fixation Systems
- Where
- 46 sites in United States, China
- Volunteers
- 600 people
- Sponsor
- Medtronic Spinal and Biologics
Spine Disease, Spinal Stenosis
CEUS For Intraoperative Spinal Cord Injury
Spinal cord injury following posterior decompression in patients suffering from chronic, cervicothoracic spinal cord compression is a known complication with multiple etiologies.
- Conditions
- Spine Disease, Spinal Stenosis, Spinal Injury, Spinal Cord Diseases
- Trial name
- NCT05530798
- Testing
- Definity Perflutren Lipid Microsphere Ultrasound Contrast
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medical University of South Carolina
Degeneration Spine
Primary Sacroiliac Fusion Versus Fusion to the Sacrum for Degenerative Disease of the Lumbar Spine
To prove that the use of additional S2alar-iliac screws for pure lumbar fusions due to degenerative lumbar disease provides superior outcome compared to the standard procedure of fusion to S1.
- Trial name
- PSEUDOLUSE (NCT04308018)
- Testing
- S2alar-iliac screws, S1 screws
- Volunteers
- 148 people
- Sponsor
- Technical University of Munich
Degenerative Disc Disease, Spinal Stenosis
Assessment of nanOss Bioactive 3D in the Posterolateral Spine
Spine fusion is one of the most common procedures performed in spinal surgery. Several surgical techniques can achieve a solid union, but the intertransverse posterolateral fusion (PLF) is the most widely used.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT01829997
- Testing
- nanOss Bioactive 3D BVF
- Where
- 4 sites in United States
- Volunteers
- 22 people
- Sponsor
- Pioneer Surgical Technology, Inc.
Spondylolisthesis, Lumbar Region
Midline Versus Paramedian Approaches in Treating Degenerative Lumbar Spondylolisthesis
For the increasing numbers of patients undergoing fusion procedures for the degenerative lumbar spine, infection and re-operation can negatively impact outcomes.
- Trial name
- NCT03344484
- Testing
- Surgical approach
- Where
- Canada
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Nova Scotia Health Authority
Cervical Spine Degenerative Disease
AO CSH Mainstream Study on Cervical Spine Degeneration
Adult patients with cervical degenerative diseases undergoing primary anterior and/or posterior cervical fusion will be prospectively enrolled from participating sites.
- Trial name
- CASDEM (NCT06845293)
- Volunteers
- 300 people
- Sponsor
- AO Innovation Translation Center
Degenerative Disc Disease, Cervical Spine Degeneration
Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.
The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2.
- Trial name
- NCT03312192
- Testing
- Interbody Cage, Interbody Cage and Anterior Plating
- Where
- United States
- Sponsor
- Rush University Medical Center
Cervical Spine Degeneration, ACDF Surgery
Function After Anterior Cervical Discectomy and Fusion Surgery: Timing of Physical Therapy
The goal of this two-group randomized clinical trial is to examine the effects of early postoperative PT compared to delayed postoperative PT for improving outcomes after hospital discharge for ACDF surgery.
- Trial name
- FAST-PT (NCT06202443)
- Testing
- Early PT, Delayed PT
- Where
- 4 sites in United States
- Volunteers
- 76 people
- Sponsor
- Vanderbilt University Medical Center
Delirium, Lumbar Radiculopathy
Shaping Anesthetic Techniques to Reduce Post-operative Delirium
The purpose of this study is to determine if light sedation with spinal anesthesia reduces the incidence of delirium compared to receiving general anesthesia during spinal surgery in older adults.
- Conditions
- Delirium, Lumbar Radiculopathy, Lumbar Osteoarthritis, Lumbar Spine Disc Degeneration
- Trial name
- SHARP (NCT03133845)
- Testing
- Light sedation with propofol, Induction with propofol, Maintenance anesthetic using a volatile anesthetic
- Where
- United States
- Volunteers
- 218 people
- Sponsor
- Johns Hopkins University
Spine Infection
Cliavist in Infectious and Degenerative Diseases of the Spine
USPIO contrast enhancement results from intracellular trapping of the iron particles in reactive cells, especially macrophages. 17FDG-PET studies have demonstrated that macrophages are present in spine infectious diseases but are…
- Trial name
- NCT00372281
- Testing
- Cliavist
- Where
- 4 sites in France
- Volunteers
- 40 people
- Sponsor
- University Hospital, Strasbourg, France
Degeneration Disc, Lumbar Spinal Stenosis
Comparisons Therapeutic Effects of Different PELD Procedure on LSS.
Different procedure of percutaneous endoscopic lumbar discectomy (PELD) was with ventral decompression of dural sac on the lumbar spinal stenosis remains unkonwn.The traditional transforaminal endoscopic spine system (TESSYS) of…
- Trial name
- NCT04314453
- Testing
- percutaneous endoscopic lumbar discectomy
- Volunteers
- 140 people
- Sponsor
- Second Affiliated Hospital of Wenzhou Medical University
Spinal Diseases
Proprioception and Eye-head Coordination for the Cervical Spine
Specific aims of this project were as follows: 1. To investigate the eye-head coordination of patients with cervical spine degeneration. 2.
- Trial name
- NCT00172237
- Where
- Taiwan
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Cervical Spondylosis, Acute Neck Pain
Comparison of Manual Acupuncture at Distal Acupoints Versus Electroacupuncture at Local Acupoints in Patients With Acute Neck Pain Due to Cervical Spondylosis
This study is a randomized, single-blind, controlled clinical trial involving two groups: manual acupuncture and electroacupuncture, with 62 participants in each group.
- Conditions
- Cervical Spondylosis, Acute Neck Pain, Neck Pain Musculoskeletal, Degenerative Cervical Spine
- Trial name
- DALA (NCT07240623)
- Testing
- Manual acupuncture at distal acupoints, Electroacupuncture at local acupoints
- Where
- Vietnam
- Volunteers
- 124 people
- Sponsor
- School of Medicine - Vietnam National University at Ho Chi Minh city
Cervical Degenerative Disc Disease
Post-Market Data Collection to Evaluate the Performance of the Synergy Disc®
This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts.
- Trial name
- NCT06383962
- Testing
- Synergy cervical spine disc replacement
- Where
- 2 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Synergy Spine Solutions
Spinal Fusion, Spinal Stenosis
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
Deep surgical site infection (DSSI) is one of the most challenging complications for spinal surgeons and can lead to a poor clinical outcome.
- Conditions
- Spinal Fusion, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT03883022
- Testing
- with U-VANCO (vancomycin hydrochloride), without U-VANCO (vancomycin hydrochloride)
- Where
- Taiwan
- Volunteers
- 400 people
- Sponsor
- Taipei Veterans General Hospital, Taiwan
Degenerative Disc Disease, Spondylolisthesis
PMCF Neo Pedicle Screw and Cage Systems
The objectives of this clinical observational study is to evaluate the safety and efficacy (performance) of the Neo Pedicle Screw System™ and the Neo Cage System™ interbody fusion device.
- Conditions
- Degenerative Disc Disease, Spondylolisthesis, Spinal Stenosis, Spinal Tumor
- Trial name
- NCT03956537
- Testing
- NEO Pedicle Screw System™, Neo Cage System™
- Where
- 2 sites in Germany, Spain
- Volunteers
- 150 people
- Sponsor
- Neo Medical SA