Clinical trials: Lumbar Spine Degenerative Changes
Lumbar Spine Degeneration, Arthrosis; Spine
Postoperative Bracing Patterns After Lumbar Surgery
A variety of postoperative bracing are routinely applied after spinal procedures but there are limited data regarding their efficacy, especially with the increasing use of internal fixation.Currently, no data are available…
- Conditions
- Lumbar Spine Degeneration, Arthrosis; Spine, Surgery
- Trial name
- NCT03427281
- Testing
- questionnaire
- Where
- Belgium
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Degenerative Disc Disease, Spine Fusion
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
This is a phase IV post-marketing study for MagnetOs Flex Matrix. MagnetOs Flex Matrix is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease and…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Leg Pain and/or Back Pain
- Trial name
- PRECISE (NCT05037968)
- Testing
- MagnetOs Flex Matrix, Trinity Elite
- Where
- 9 sites in United States
- Volunteers
- 100 people
- Sponsor
- Kuros Biosurgery AG
Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease
Effect of RECK in Posterior Spinal Fusion
"RECK" is a combination of local anesthesia medications, used for the purpose of pain control. RECK is an acronym which stands for Ropivacaine, Epinephrine, Clonidine, and Ketorolac.
- Conditions
- Degenerative Lumbar Spinal Stenosis, Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Disease
- Trial name
- NCT06447194
- Testing
- Ropivacaine, Epinephrine, Clonidine, and Ketorolac Injection Cocktail
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Degenerative Lumbar Spine Diseases
Outcomes of Surgery for Degenerative Lumbar Spine Diseases
The purpose of this study is to determine the effectiveness of surgery on the elderly patients with DSD.
- Trial name
- NCT06540274
- Testing
- lumbar surgery
- Where
- Egypt
- Volunteers
- 49 people
- Sponsor
- Assiut University
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 Lumbar Spine Diseases
Digital Health for Lumbar Degeneration
This study will integrate wireless wearable sensors, smartphone imaging, and multimodal artificial intelligence (AI) to address the rehabilitation needs of patients with lumbar degeneration.
- Trial name
- NCT07133724
- Testing
- AI-Based Smart Assessment and Rehabilitation Training
- Where
- Taiwan
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Spine Injuries and Disorders
Which Markers of Musculoskeletal Health Can Explain Complications in Spinal Surgery?
The present study is related to the project "ORTHOSPINE FITNESS: WHICH MARKERS OF MUSCULOSKELETAL HEALTH CAN EXPLAIN COMPLICATIONS IN SPINE SURGERY?", winner of the Ministry of Health Call, financed by the European Union…
- Trial name
- NCT06736106
- Testing
- screening
- Where
- 2 sites in Italy
- Volunteers
- 200 people
- Sponsor
- Istituto Ortopedico Rizzoli
Stenosis, Spondylolisthesis
Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft
The purpose of this study is to compare Optecure™ as an autograft extender (treatment) to autograft alone (control) in patients undergoing 1 or 2 level fusion of the lumbar spine(one level is defined as two adjacent vertebrae)…
- Conditions
- Stenosis, Spondylolisthesis, Degenerative Disc Disease
- Trial name
- NCT00254852
- Testing
- Posterior Lateral Fusion (PLF), Anterior Lumbar Interbody Fusion (ALIF), Transforaminal lumbar interbody fusion (TLIF)
- Where
- 6 sites in United States
- Volunteers
- 94 people
- Sponsor
- Exactech
Lumbar Spine Disease, Instabilities Lumbar
Registry for Evaluation of Lumbar Arthrodesis Sagittal alignmEnt
The study goal of RELApSE is to evaluate the relationships between radiological data and patients reported outcome. Restoration of Sagittal alignment and Pelvic Index (PI)-Lumbar Lordosis (LL) mismatch is closely associated with…
- Conditions
- Lumbar Spine Disease, Instabilities Lumbar, Lumbar Spine Instability
- Trial name
- RELAPSE (NCT05448092)
- Where
- 8 sites in Italy
- Volunteers
- 500 people
- Sponsor
- Unit of neurosurgery, Departement of Neurosciences, University of Torino
Degenerative Disc Disease, Degenerative Spondylolisthesis
Lumbar Interbody Implant Study
The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and…
- Conditions
- Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis
- Trial name
- NCT04418830
- Where
- 16 sites in United States
- Volunteers
- 1,050 people
- Sponsor
- NuVasive
Failed Back Surgery Syndrome, Degeneration Lumbar Spine
Restoring Segmental Lumbar Lordosis After Failed Previous Fusion at the Same Level
The restoration of lumbar lordosis is mandatory during lumbar fusion surgery for degenerative disc disease, since not restoring lumbar lordosis adequately may adversely affect surgical outcomes and the patient's quality of life…
- Conditions
- Failed Back Surgery Syndrome, Degeneration Lumbar Spine, Degenerative Spondylolisthesis, Sagittal Imbalance
- Trial name
- NCT07050290
- Testing
- Restoring segmental lordosis at the lumbar spine
- Where
- Russia
- Volunteers
- 20 people
- Sponsor
- N.N. Priorov National Medical Research Center of Traumatology and Orthopedics
Lumbar Degenerative Disc Disease, Lower Back Pain
Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine
Investigate the potential of tissue grafting that includes human mesenchymal stem cells in the repair and potential stabilization of the degenerative Lumbar disk and facet joint denovo and at the time of surgical reconstruction.
- Conditions
- Lumbar Degenerative Disc Disease, Lower Back Pain, Chronic Lower Back Pain
- Trial name
- NCT02529566
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The Foundation for Spinal Research, Education and Humanitarian Care, Inc.
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.
Low Back Pain, Spondylolisthesis
Evaluation of Aspen Spinous Process Fixation System and PLIF Technique for the Treatment of Low Back Pain
Lumbar spinal fusion was introduced approximately 70 years ago and has evolved as a treatment option for symptomatic spinal instability, spinal stenosis, spondylolisthesis, and degenerative scoliosis.
- Conditions
- Low Back Pain, Spondylolisthesis, Spondylosis, Spinal Instability
- Trial name
- NCT01918943
- Testing
- PLIF and Aspen (spinous process fixation device)
- Where
- Mexico
- Volunteers
- 50 people
- Sponsor
- American British Cowdray Medical Center
Osteoporosis, Degenerative Disc Disease
3D-printed Porous Titanium Alloy Cages Versus PEEK Cages in Patients With Osteoporosis
This is a prospective,observational single-center study. The osteoporotic patients requiring posterior lumbar interbody fusion(PLIF) with cages at the lowest fusion segment are prospectively enrolled and followed up.
- Conditions
- Osteoporosis, Degenerative Disc Disease, Degenerative Lumbar Spinal Stenosis, Degeneration Spine
- Trial name
- 3DCOP (NCT04086784)
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Peking University Third Hospital
Osteoporosis, Degenerative Lumbar Disease
Osteo Match Cages Versus PEEK Cages in Osteoporotic Patients
This is a multicenter, prospective cohort study. The osteoporotic patients requiring posterior lumbar interbody fusion(LIF) with cages are prospectively enrolled and followed up.
- Conditions
- Osteoporosis, Degenerative Lumbar Disease, Degeneration Spine
- Trial name
- OMC (NCT05981222)
- Where
- China
- Volunteers
- 1,500 people
- Sponsor
- Peking University Third Hospital
Lumbar Spinal Stenosis, Degenerative Spondylolisthesis
A Pivotal Study of the Premia Spine TOPS™ System
The purpose of this trial is to assess whether the Total Posterior Spine System (TOPS System) is more effective than transforaminal lumbar interbody fusion (TLIF) when used to stabilize a single lumbar level (L2 - L5) following…
- Trial name
- NCT03012776
- Testing
- Total Posterior Spine System (TOPS), Transforaminal Lumbar Interbody Fusion (TLIF)
- Where
- 36 sites in United States
- Volunteers
- 305 people
- Sponsor
- Premia Spine
Degenerative Conditions of the Lumbar Spine
AttraX® Putty vs. Autograft in XLIF®
The objective of this study is to evaluate the clinical success of AttraX Putty as a bone graft substitute for autograft in XLIF procedures.
- Trial name
- NCT02250248
- Testing
- AttraX Putty, Iliac Crest Bone Graft (ICBG)
- Where
- Brazil
- Volunteers
- 45 people
- Sponsor
- NuVasive
Cervical Disc Disorder With Radiculopathy, Spinal Stenosis
Comparative Study of Gene-Activated Bone Substitute "Histograft" for Lumbar and Cervical Spinal Fusion
The goal of this clinical trial is to evaluate the safety and efficacy of the combination product "Histograft", a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene, in spinal fusion…
- Conditions
- Cervical Disc Disorder With Radiculopathy, Spinal Stenosis, Lumbar and Other Intervertebral Disc Disorders With Radiculopathy, Biomechanical Lesion, Unspecified
- Trial name
- NCT06365307
- Testing
- Osteoplastic material based on octacalcium phosphate and biologically active nucleic acids for bone tissue regeneration Nucleostim-VEGF ("Histograft"), Synthetic osteoplastic material based on β-TCP or bone autograft
- Where
- Russia
- Volunteers
- 300 people
- Sponsor
- Histograft Co., Ltd.
Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis
Mid- or High-flex Rods Versus Low-flex Rods of SpineShape System IV for Treatment of Degenerative Lumbar Spine Diseases
The purpose of this multi-center, randomized, clinical study is to show that the treatment of degenerative lumbar spine with high- or mid-flex rods is not inferior to the treatment with low-flex rods in terms of clinical and…
- Conditions
- Degenerative Lumbar Spinal Stenosis, Facet Joint Arthrosis, Spondylarthritis, Discopathy
- Trial name
- NCT06320899
- Testing
- SpineShape System IV straight rod elastic, SpineShape System IV straight rod medium, SpineShape System IV straight rod stiff
- Where
- 2 sites in Switzerland
- Volunteers
- 126 people
- Sponsor
- SpineSave AG