Clinical trials: Lumbar Fusion
Degenerative Disc Disease, Spinal Stenosis
Single-Armed Use of ViviGen Cellular Bone Matrix in Patients Undergoing Posterolateral Lumbar Surgery
This is a prospective, single-arm post market study of patients to assess fusion in one or multiple continuous levels of the lumbosacral spine (L1-S1) using ViviGen Cellular Bone Matrix.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylosis, Spondylolisthesis
- Trial name
- NCT04007094
- Testing
- ViviGen Cellular Bone Matrix
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Ohio State University
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
Degenerative Disc Disease, Spinal Stenosis
Clinical Outcomes of the Trinica(R) Anterior Lumbar Plate: Fixed Screws vs. Variable Screws
Trinica Anterior Lumbar Plate (ALP) System is a commercially available, supplemental fusion device for use in the lumbar or sacral spine (L1-S1) to treat instability.
- Conditions
- Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
- Trial name
- NCT00762723
- Testing
- Trinica Anterior Lumbar Plate System
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- Zimmer Biomet
Spinal Stenosis, Inflammation
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
The aim of the proposed study is to examine the effect of DEX on the inflammatory response in major surgery. More importantly, the investigators will correlate changes in the concentration of inflammatory mediators with…
- Trial name
- NCT01377623
- Testing
- Dexmedetomidine group
- Where
- 2 sites in United States
- Volunteers
- 66 people
- Sponsor
- NYU Langone Health
Lumbar Spondylolisthesis, Degenerative Disc Disease
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively…
- Conditions
- Lumbar Spondylolisthesis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Lumbar Radiculopathy
- Trial name
- ViviGen (NCT03733626)
- Testing
- ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system, Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Corewell Health East
Transforaminal Lumbar Interbody Fusion
Effect of Catheter on Postoperative Urinary Retention
To determine if indwelling Foley placement at the onset of the procedure, straight catherization at the conclusion of the procedure, or no catheterization produces the lowest rates of postoperative urinary retention after…
- Trial name
- NCT04645264
- Testing
- Foley Catheter
- Where
- United States
- Volunteers
- 7 people, healthy volunteers welcome
- Sponsor
- Rush University Medical Center
Spinal Fusion Acquired, Spinal Stenosis
Intraoperative Infusion of Precedex to Reduce Length of Stay After Lumbar Spine Fusion
Major lumbar spine surgery causes inflammation, soreness and swelling that can delay discharge from the hospital. Dexmedetomidine (DEX) has been shown to have anti-inflammatory effects.
- Conditions
- Spinal Fusion Acquired, Spinal Stenosis, Lesions of Lumbosacral Intervertebral Disc, Spinal Diseases
- Trial name
- DEXREDLOS (NCT00808665)
- Testing
- Dexmedetomidine, 0.9% Saline
- Where
- United States
- Volunteers
- 68 people
- Sponsor
- Vanderbilt University Medical Center
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
Lumbar Spine Degeneration
INFUSE®Bone Graft in Transforaminal Lumbar Interbody Fusion for Degenerative Disease of Lumbosacral Spine
This investigation will provide safety and effectiveness information on the use of INFUSE® Bone Graft with the CAPSTONE® Spinal System and CD HORIZON® Spinal System with a Transforaminal Lumbar Interbody Fusion (TLIF) surgical…
- Trial name
- TLIF (NCT01415908)
- Testing
- INFUSE Bone Graft, Iliac Crest Bone Graft
- Where
- 5 sites in United States
- Volunteers
- 15 people
- Sponsor
- Medtronic Spinal and Biologics
Intervertebral Disc Disease
Clinical and Radiological Evaluation of Patients With DDD Following TLIF With 3-D Printed Titanium Cage
The purpose of this study is to evaluate the fusion rate and clinical outcomes at 1 year of 20 patients with degenerative disc disease who undergo a Transforaminal Lumbar Interbody Fusion (TLIF) with the Stryker Tritanium Spinal…
- Trial name
- NCT03018392
- Testing
- Stryker Tritanium Spinal System
- Volunteers
- 20 people
- Sponsor
- Bone and Joint Clinic of Baton Rouge
Raised Ocular Pressure
Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
A rare but terrible complication of vision loss has been known to occur after surgery, including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is one of the reasons for this rare vision loss.
- Trial name
- IOP (NCT02342288)
- Testing
- Head raised 10 degrees, Head in neutral position
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- West Virginia University
Lumbar Disease
Radiographic and Clinical Outcomes Following Unilateral or Bilateral Posterior Fixation in MI-TLIF
The purpose of this study is to compare the healing of the patients spine at 24-months following surgery and screw placement among 3 groups.
- Trial name
- NCT01996371
- Testing
- Pedicle Screw
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- H Francis Farhadi, MD, PhD
Lumbar Degenerative Disc Disease
Radiographic Analysis Using PureGen Versus Autologous Bone in Posterolateral Fusion (PLF)
The purpose of this study is to evaluate the rate and quality of fusion of PureGen Osteoprogenitor Cell Allograft, compared to autograft bone in instrumented posterolateral fusion (PLF) procedures.
- Trial name
- NCT01294007
- Testing
- PureGen Osteoprogenitor Cell Allograft, Autograft bone
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Alphatec Spine, Inc.
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
Prolapsed Lumbar Disc, Prolapsed Cervical Disc
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device
The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and…
- Conditions
- Prolapsed Lumbar Disc, Prolapsed Cervical Disc, Intervertebral Disc Degeneration, Spondylolisthesis, Grade 1
- Trial name
- NCT01944345
- Where
- 3 sites in United States
- Volunteers
- 69 people
- Sponsor
- Wenzel Spine
Degenerative Disc Disease
TXA in Spinal Fusion
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels.
- Trial name
- NCT04272606
- Testing
- Tranexamic Acid, Saline Solution, Visual Acuity Exam
- Where
- United States
- Volunteers
- 123 people
- Sponsor
- Catherine R. Olinger
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
Degenerative Changes, Stenosis
Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
- Conditions
- Degenerative Changes, Stenosis, Spondylosis
- Trial name
- NCT02018445
- Testing
- Posterolateral Fusion
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- SeaSpine, Inc.
Low Back Pain
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion
The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar…
- Trial name
- NCT02061774
- Testing
- Acetaminophen
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Texas Tech University Health Sciences Center
Lumbar Spinal Fusions
Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
Acute pain management is challenging in patients after spinal fusions, particularly since most have taken analgesics for prolonged periods before choosing the surgical alternative.
- Trial name
- NCT01366196
- Testing
- Pregabalin 150 mg
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Hospital for Special Surgery, New York