Clinical trials: Lumbar Fusion
Degenerative Lumbar Spine Causing Back and/or Leg Pain, Lumbar Spine Degeneration
A Prospective, Multicenter Observational Study on MAST™ (Minimal Access Spinal Technologies) Fusion Procedures for the Treatment of the Degenerative Lumbar Spine
The aim of the study is to observe and document surgical practice and evaluate patients' outcomes following a MAST™ single or double level instrumented fusion procedure using PLIF (Posterior Lumbar Interbody Fusion) or TLIF…
- Trial name
- MASTERS-D (NCT01143324)
- Testing
- MAST™ procedure
- Where
- 19 sites in Austria, Belgium and 12 more
- Volunteers
- 255 people
- Sponsor
- Medtronic Spinal and Biologics
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.
Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis
Lumbar Fusion With Nexxt Spine 3D-Printed Titanium Interbody Cages
The purpose of this randomized controlled trial is to assess and compare radiographic and clinical outcomes in patients who are to undergo combined interbody/posterolateral lumbar fusion procedures, supplemented with pedicle…
- Conditions
- Lumbar Degenerative Disc Disease, Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Spinal Deformity
- Trial name
- NCT03647501
- Testing
- Interbody cage (titanium), Interbody cage (PEEK)
- Where
- United States
- Volunteers
- 53 people
- Sponsor
- Ohio State University
Degeneration of Lumbar Intervertebral Disc
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)
The purpose of this study was to collect data to demonstrate the safety and effectiveness of the OptiMesh 1500S to contain and reinforce bone graft materials in patients with Degenerative Disc Disease (DDD) whose condition…
- Trial name
- OLIF (NCT00764491)
- Testing
- Structural Allograft Spacer, OptiMesh 1500S
- Where
- 11 sites in United States
- Volunteers
- 156 people
- Sponsor
- Spineology, Inc
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
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
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
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
Lumbar Degenerative Disc Disease, Spinal Stenosis
Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease
The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.
- Conditions
- Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis
- Trial name
- NCT02070484
- Testing
- NuCel, Demineralized Bone Matrix
- Where
- 2 sites in United States
- Volunteers
- 6 people
- Sponsor
- OhioHealth
Lumbar Spine Degeneration
rhBMP-2 Versus Vivigen in Lumbar Fusion Procedures
This study is aimed at comparing the overall efficacy (clinical and radiographic) of Vivigen, a novel cellular allograft product, and rhBMP-2 when utilized in lumbar fusion procedures.
- Trial name
- NCT03527966
- Testing
- 5cc Vivigen and local autograft, Small kit rhBMP-2 with local autograft
- Where
- United States
- Volunteers
- 3 people, healthy volunteers welcome
- Sponsor
- Virtua Health, Inc.
Fusion of Spine, Lumbar Region
The Effectiveness of IV/PO Acetaminophen in the Perioperative Period in Reducing Opiate Use After Lumbar Spine Fusion
Simple explanation and rationale: Recovery after spine surgery is usually accompanied by severe pain which has traditionally been managed with opioids.
- Trial name
- NCT03104816
- Testing
- Acetaminophen IV Soln 10 MG/ML, Acetaminophen, Hydromorphone
- Where
- United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- University of Southern California
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
Postoperative Pain Management
Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Primary Objective: The primary objective of this study is to compare postsurgical opioid consumption through 72 hours postsurgery in patients receiving local infiltration analgesia (LIA) with EXPAREL and bupivacaine HCl (EXPAREL…
- Trial name
- FUSION (NCT03927911)
- Testing
- EXPAREL and Bupivacaine, Standard of Care
- Where
- 12 sites in United States
- Volunteers
- 65 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Degenerative Lumbar Spinal Stenosis
DIAM™ Spinal Stabilization System vs. Decompression, Formerly vs. Posterolateral Fusion
The purpose of this clinical trial is to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System as a method of treating patients with symptoms of degenerative lumbar spinal stenosis at a single level from…
- Trial name
- NCT00627497
- Testing
- Single-Level Posterior Decompression, DIAM Spinal Stabilization, Fusion
- Where
- 9 sites in United States
- Volunteers
- 32 people
- Sponsor
- Medtronic Spinal and Biologics
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 Degenerative Disc Disease
Prospective Study of Thoracolumbar Spinal Fusion Graft
This study is a single-center, prospective randomized clinical study intended to compare and evaluate the efficacy of subjects who are treated with bone marrow aspirate concentrate (BMAC) and allograft to iliac crest bone grafts…
- Trial name
- BMAC (NCT02297256)
- Testing
- BMAC & Allograft, Iliac Crest Bone Graft
- Where
- 3 sites in United States
- Volunteers
- 17 people
- Sponsor
- NYU Langone Health
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
Lumbar Spine Fusion, Pain
Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
1. Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study 2.
- Conditions
- Lumbar Spine Fusion, Pain, Back Pain
- Trial name
- NCT01986946
- Testing
- Epidural Catheter - Dilaudid, Dilaudid
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Duke University
Stenosis, Spondylosis
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral 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 posterolateral spine fusion with a retrospective comparison to a historical patient…
- Conditions
- Stenosis, Spondylosis, Degenerative Changes
- Trial name
- NCT01430299
- Testing
- Demineralized Bone Matrix, rh-BMP2
- Where
- United States
- Volunteers
- 43 people
- Sponsor
- SeaSpine, Inc.