Clinical trials: Lumbar Spine Fusion
Back Pain, Fusion of Spine, Lumbar Region
The Comparison of Postoperative Pain After Lumbar Fusion Surgery in Intravenous Patient-controlled Analgesia Between Conventional Mode and Optimizing B.I Mode With 'PAINSTOP' Equipment
The postoperative pain of lumbar fusion surgery is very severe that it is necessary to use additional analgesics as well as a patient controlled analgesia (PCA).
- Conditions
- Back Pain, Fusion of Spine, Lumbar Region, Spinal Stenosis
- Trial name
- NCT03047044
- Testing
- Optimizing basal infusion (B.I), Conventional PCA mode
- Where
- South Korea
- Volunteers
- 58 people, healthy volunteers welcome
- Sponsor
- Yonsei University
Single-level Lumbar Arthrodesis
Intravenous Lidocaine Versus Erector Spinae Plane Block After Lumbar Arthrodesis (LIBERA)
The hypothesis of this study is that intraoperative intravenous lidocaine infusion provides postoperative analgesia and opioid-sparing effects that are at least equivalent to those achieved with a bilateral erector spinae plane…
- Trial name
- LIBERA (NCT07895368)
- Testing
- Single-level posterior lumbar arthrodesis
- Where
- France
- Volunteers
- 90 people
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
Lumbar Spinal Fusion
Efficacy of TLIP Block for Postoperative Analgesia of Lumbar Spinal Fusion
Spinal surgery is associated with severe pain in the immediate postoperative period. In a recent study evaluating pain intensity on the first day after surgery in a large range of surgical procedures, among the six most painful…
- Trial name
- ETLA (NCT04593953)
- Testing
- TLIP
- Where
- 2 sites in France
- Volunteers
- 94 people
- Sponsor
- CMC Ambroise Paré
Spinal Stenosis
MIS-D Versus MIS-TLIF for the Treatment of Lumbar Spinal Stenosis
The purpose of this study is to evaluate the effectiveness of two minimal invasive spine surgery, minimally invasive spinal decompression (MIS-D) and minimally invasive spinal decompression and fusion (MIS-TLIF), for patients…
- Trial name
- NCT04318795
- Testing
- minimally invasive spinal decompression (MIS-D), minimally invasive spinal decompression and fusion (MIS-TLIF)
- Volunteers
- 80 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
Intervertebral Disc Degeneration
Safety and Performance of the SpineVision Posterior Fixation Systems in Thoracolumbar Spinal Treatment
The goal of this observational study is to confirm the safety and performance of the three (3) Spinevision posterior fixations systems Lumis®, Plus® and Ulis® , in the treatment of patient suffering from thoracolumbar spinal…
- Trial name
- FixedD3 (NCT06342765)
- Testing
- Pedicle fixation surgery
- Where
- 3 sites in France
- Volunteers
- 330 people
- Sponsor
- SPINEVISION SAS
Spondylolisthesis
Posterior Lateral Fusion (PLF) With Dynesys
The primary purpose of this study is to track and document the clinical outcomes of patients with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
- Trial name
- NCT00791180
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Zimmer Biomet
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
Lumbar Spine Disease
Irrisept Spinal Fusion Pilot Study Protocol
Study objectives include assessing the use of Irrisept irrigation solution in lumbar spinal fusion procedures and effect on clinical and patient reported outcome measures.
- Trial name
- NCT05011942
- Testing
- Irrisept Irrigation solution
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- University of Kansas Medical Center
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.
Spine Surgery
3rd-year Post-surgical Evaluation of Adjacent Segment Disc Degeneration Onset in Lumbar Spine (Spinal Fusion vs. Lumbar Arthroplasty With Disc Replacement)
The main objective of the study is to compare the onset of adjacent segment disk degeneration in two groups of patients (one "spinal fusion group" and one "lumbar arthroplasty with disc replacement" group) with each patient…
- Trial name
- ARTHRO-DEGE (NCT05561322)
- Testing
- Consultation involving pain evaluation, questionnaires and the Lasègue Manoeuver, Magnetic Resonance Imaging of the lumbar spine
- Where
- France
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Lumbar Spinal Stenosis, Lumbar Spondylolisthesis
Cognitive Behavioral Therapy (CBT) After Lumbar Spinal Fusion in Patients With High Pain Catastrophizing
Catastrophizing has emerged as the strongest independent predictor for persistent postsurgical pain. Although behavioral interventions, including Cognitive Behavioral Therapy (CBT), have been shown to reduce the impact of…
- Conditions
- Lumbar Spinal Stenosis, Lumbar Spondylolisthesis, Lumbar Instability, Spinal Disease
- Trial name
- TRIBECA (NCT03969602)
- Testing
- Cognitive-behavioral Therapy, Biomedical and surgery-specific education
- Where
- Switzerland
- Volunteers
- 126 people
- Sponsor
- Neurocenter of Southern Switzerland
Posterior Lumbar Spinal Fusion Surgery
Protective Effect of Tranexamic Acid on Shedding of the Endothelial Glycocalyx in Patients Undergoing Spinal Fusion Surgery
The aim of this study was to determine whether the administration of tranexamic acid in patients undergoing lumbar spinal fusion surgery can inhibit damage in endothelial glycocalyx layer.
- Trial name
- NCT03697681
- Testing
- Tranexamic acid, 0.9% NaCl (normal saline)
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Yonsei University
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 Conditions of the Lumbar Spine, Lumbar Spinal Stenosis
Post-Market Clinical Study of Functional Motion Outcomes in Subjects Treated With the Minuteman Device
This is a prospective, multi-center open-label single arm post-market study where the purpose is to evaluate the effectiveness and safety of the market approved Spinal Simplicity Minuteman G5 MIS Fusion Plate and bone graft…
- Conditions
- Degenerative Conditions of the Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis
- Trial name
- STABILITY (NCT06355791)
- Testing
- Minuteman G5 Device
- Where
- 6 sites in United States
- Volunteers
- 150 people
- Sponsor
- Spinal Simplicity LLC
Lumbar Spine Degeneration, Physical Disability
Delphi Study on Rehabilitation Following Lumbar Arthrodesis
Delphi study on perioperative rehabilitation after single and double level lumbar arthrodesis.
- Conditions
- Lumbar Spine Degeneration, Physical Disability, Surgery
- Trial name
- NCT03427294
- Testing
- Delphi study
- Where
- Belgium
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Low Back Pain, Recurrent Lumbar Disc Herniation
Surgical Treatment Comparison for Recurrent Lumbar Disc Herniation
The purpose of this study is to compare patients who underwent decompression/discectomy with pedicle screw fusion to patients who received decompression/discectomy without fusion.
- Trial name
- NCT00444405
- Sponsor
- Mercy Research
Spinal Stenosis, Spondylolisthesis
Decompression vs. Fusion for Stable Degenerative Spondylolisthesis
The purpose of this study is to assess the feasibility of a full-scale multicenter randomized, controlled trial comparing the effectiveness of two surgical treatments for a condition associated with lumbar spinal stenosis called…
- Trial name
- NCT02348645
- Testing
- Spinal fusion, Spinal decompression
- Where
- 8 sites in Canada
- Volunteers
- 70 people
- Sponsor
- University Health Network, Toronto
Pain, Postoperative
Erector Spinae Plane Block Analgesia for Lumbar Spine Fusion Surgery
The purpose of this study was to investigate the effect of a bilateral ultrasound guided erector spinae plane block on the pain scores and opoid utiliziation in fusion surgery of the lumbar spine.
- Trial name
- NCT04749095
- Testing
- Erector spinae plane block
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Benha University
Low Back Pain
The Effect of Graded Activity and Pain Education (GAPE) for Patients Early After Lumbar Spinal Fusion
Background An increasing number of patients with chronic low back pain (CLBP) undergo lumbar spinal fusion (LSF). Unfortunately, a substantial part of the patients still has persistent pain, functional disability and poor quality…
- Trial name
- NCT04103970
- Testing
- Graded Activity and Pain Education (GAPE)
- Where
- Denmark
- Volunteers
- 144 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Lumbar Spine Instability, Lumbar Spinal Stenosis
Efficacy of Surgical Injection Lumbar Erector Spinae Plane Block
Lumbar spinal surgery is one of the operations performed for the treatment of leg and back pain. Severe pain may occur at postoperative period in patients following lumbar fusion surgery.
- Conditions
- Lumbar Spine Instability, Lumbar Spinal Stenosis, Lumbar Spine Degeneration
- Trial name
- NCT05630404
- Testing
- Surgical ESPB, US guided ESPB
- Where
- Turkey (Türkiye)
- Volunteers
- 90 people
- Sponsor
- Bursa City Hospital