Clinical trials: Lumbar Spine Pathology
Degenerative Disc Disease, Spine Fusion
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
This is a phase IV post-marketing study for MagnetOs Easypack Putty. MagnetOs Easypack Putty is a synthetic bone graft extender product that is routinely used by surgeons as a treatment for patients with degenerative disc disease…
- Conditions
- Degenerative Disc Disease, Spine Fusion, Back Pain
- Trial name
- PROOF (NCT04679844)
- Testing
- MagnetOs Easypack Putty, Demineralized Bone Matrix or Fibers mixed with local autograft bone
- Where
- 6 sites in United States
- Volunteers
- 60 people
- Sponsor
- Kuros Biosurgery AG
Degenerative Disc Disease
A Study Comparing the Safety and Effectiveness of Cartilage Cell Injected Into the Lumbar Disc as Compared to a Placebo
This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
- Trial name
- NCT01771471
- Testing
- NuQu
- Where
- 10 sites in United States
- Volunteers
- 44 people
- Sponsor
- ISTO Technologies, Inc.
Degenerative Disc Disease, Back Pain
Osteocel® Plus in eXtreme Lateral Interbody Fusion (XLIF®)
This is a prospective, non-randomized multi-center study to compare the use of Osteocel® Plus in subjects who receive XLIF® (eXtreme Lateral Interbody Fusion) surgery at one or two levels.
- Trial name
- NCT00948532
- Testing
- biologic, Osteocel Plus
- Where
- 13 sites in United States
- Volunteers
- 104 people
- Sponsor
- NuVasive
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 Disc Herniation
Compare the Effects of Decompression on Lumber Disc Protrusion Patient
This is an RCT study in which 60 participant are included and half of the participant are randomized via lottery method in control and experimental group after fulfilling the inclusion criteria.
- Trial name
- NCT04860609
- Testing
- Conventional Physiotherapy, Lumber Spinal Decompression
- Where
- Pakistan
- Volunteers
- 60 people
- Sponsor
- Aqua Medical Services (Pvt) Ltd
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
Lumbar Disc Herniation, Annular Tear of Lumbar Disc
Post-Marketing Clinical Follow-Up of a Spine Implant
Post-Marketing Clinical Follow-up of an Anular Closure System (Barricaid®) to Confirm Comparability of Outcome between Devices with Subcomponents from Two Different Suppliers
- Trial name
- PMCFU (NCT03180749)
- Testing
- Follow up per standard of care
- Where
- 6 sites in Germany, Switzerland
- Volunteers
- 90 people, healthy volunteers welcome
- Sponsor
- Intrinsic Therapeutics
Spine Surgery
Use of CADISS Medical Device to Facilitate Dissection of Epidural Fibrosis in Revision Spine Surgery
The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments.
- Trial name
- NCT05016739
- Testing
- CADISS
- Where
- Belgium
- Volunteers
- 21 people
- Sponsor
- AuXin Surgery SA
Back Pain, Back Disorder
Clinical Trial of Dvectis Pads in Comparison to no Pad Use in Patients With Chronic Lumbar Spine Pain
1. Introduction 1.1 Description of the Trial The trial was a monocentric, open, randomized, 3-arm clinical trial that took place at the Department of Orthopaedics of the Karviná Miners' Hospital (Karvinská hornická nemocnice…
- Conditions
- Back Pain, Back Disorder, Disease Lumbar Spine
- Trial name
- NCT03947580
- Testing
- Use of the Dvectis Single pad, Use of the Dvectis Double pad, Use of no pad
- Where
- Czechia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- DD-Hippero s.r.o.
Lumbar Spinal Stenosis, Lumbar Disc Herniation
Efficacy and Safety of Ionized Atelocollagen Adhesion Barrier (Collabarrier®) in Spine Surgery
This multicenter, randomized, subject- and evaluator-blinded, active-controlled, non-inferiority clinical trial was conducted to evaluate the efficacy and safety of Collabarrier®, a collagen-based adhesion barrier, compared to…
- Conditions
- Lumbar Spinal Stenosis, Lumbar Disc Herniation, Epidural Fibrosis, Postoperative Adhesion
- Trial name
- NCT07153822
- Testing
- Collagen-based adhesion barrier, Sodium hyaluronate(HA) and Sodium Carboxymethylcellulose(CMC)-based adhesion barrier
- Where
- 6 sites in South Korea
- Volunteers
- 69 people
- Sponsor
- DALIM TISSEN Co., Ltd.
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, Spondylolisthesis
Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device
Lumbar spinal fusion is commonly performed as a "last resort" in patients with chronic low back pain caused by degenerative changes and instability of the spine.
- Conditions
- Low Back Pain, Spondylolisthesis, Spinal Stenosis, Intervertebral Disc Displacement
- Trial name
- NCT00095095
- Testing
- Lumbar Interbody Fusion
- Where
- 4 sites in Germany, Netherlands
- Volunteers
- 102 people
- Sponsor
- Medtronic Spinal and Biologics
Lumbar Disc Herniation, Degenerative Spinal Stenosis
CETIS-I (CEra Traction Improves Spine-I)
In this clinical trial, equivalence is evaluated by exploratory comparison of changes in X-Ray lesions with test group (Cerazem Master V6) and control group (physical therapy) in patients with intervertebral disc herniation and…
- Conditions
- Lumbar Disc Herniation, Degenerative Spinal Stenosis, Spine Traction
- Trial name
- NCT05549596
- Testing
- Ceragem Master V6 Traction, Physical therapy with standard traction device
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- Ceragem Clinical Inc.
Lumbar Radiculopathy, Lumbar Disc Herniation
Randomized Evaluation of Lumbar Injection Effectiveness and Function
The goal of this clinical trial is to learn whether the Triojection® System is safe and effective for treating symptomatic lumbar radiculopathy (leg pain caused by nerve irritation or compression) resulting from a contained…
- Conditions
- Lumbar Radiculopathy, Lumbar Disc Herniation, Contained Herniated Lumbar Disc
- Trial name
- RELIEF (NCT07856810)
- Testing
- Triojection® System, Selective Nerve Root Block (SNRB)
- Volunteers
- 300 people
- Sponsor
- SpinaFX Medical Inc.
Osteoarthritis, Pain
Norspan® Patches Versus Tramadol in Subjects With Chronic, Moderate to Severe Osteoarthritis Pain in the Hip Knee and/or Lumbar Spine
The primary objective of this equivalence study is to evaluate the efficacy of Norspan® patches versus Tramadol in subjects with chronic, moderate to severe osteoarthritis pain of the hip, knee and/or lumbar spine.
- Trial name
- NCT00426647
- Testing
- Buprenorphine, Tramadol
- Where
- Finland
- Volunteers
- 120 people
- Sponsor
- Norpharma A/S
Low Back Pain
Wallis Mechanical Normalization System for Low Back Pain
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
- Trial name
- NCT00134537
- Testing
- Interspinous process and dynamic stabilization, Conservative Care
- Where
- 17 sites in United States
- Volunteers
- 300 people
- Sponsor
- Zimmer Spine