Clinical trials: Lumbar
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
PMCF Study Fortilink-TC Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-TC Ti cage of Paradigm Spine GmbH, up to one year after the surgery.
- Trial name
- NCT07834931
- Testing
- Transforaminal lumbar interbody fusion surgery
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Lumbar Puncture
The First Puncture Success Rate of a Novel Injeq IQ-Tip™ System in Pediatric Lumbar Punctures
The investigation aims to demonstrate the first puncture success rate, as proxy of clinical benefit and clinical performance, of bioimpedance spectroscopy based spinal needle guidance method among pediatric hemato-oncology…
- Trial name
- IQ-LP-03 (NCT04070144)
- Testing
- IQ-Tip(tm) system
- Where
- 3 sites in Finland
- Volunteers
- 50 people
- Sponsor
- Injeq Ltd
Cervical and Lumbar Fusion
Evaluation of the Fortilink IBF System With TETRAfuse Technology
This is a multi-center, post-market, retrospective study to collect safety and performance data for patients implanted with the Fortilink IBF System.
- Trial name
- ENTRUST (NCT03699891)
- Testing
- Fortilink IBF System with TETRAfuse Technology
- Where
- 5 sites in United States
- Volunteers
- 119 people
- Sponsor
- RTI Surgical
Lumbar Total Disk Replacement
French Lumbar Total Disk Replacement Observational Study
Primary Objective: To evaluate the rate of re-operation during the first 5 years following the fitting of lumbar total disk replacement at the operated level and / or floors above and / or underlying, whatever the reasons
- Trial name
- PTDL (NCT02381574)
- Where
- 70 sites in France
- Volunteers
- 600 people
- Sponsor
- Medtronic France SAS
Degenerative Disc Disease, Spondylolisthesis
Evaluation of NB1 Bone Graft Following Lumbar Interbody Arthrodesis
The objective of this clinical study is to evaluate the safety and effectiveness of NB1 Bone Graft in subjects with degenerative disc disease undergoing transforaminal lumbar interbody fusion.
- Trial name
- NCT03810573
- Testing
- NB1
- Where
- 2 sites in Australia
- Volunteers
- 30 people
- Sponsor
- Bone Biologics Corp
Pediatric Lumbar Puncture
Identification of Cerebrospinal Fluid With Injeq IQ-Needle During Paediatric Lumbar Puncture
This is clinical feasibility study on the device performance with paediatric patients. The main objective is to validate the performance of investigational device in distinguishing and identifying the cerebrospinal fluid (CSF)…
- Trial name
- NCT02792660
- Testing
- Injeq IQ-Needle
- Where
- 2 sites in Finland
- Volunteers
- 40 people
- Sponsor
- Injeq Ltd
Multiple MRI Exams, Including, Cardiac
General Investigative MRI Protocol
This study is a feasibility study to evaluate new technology to improve the MRI experience, with coils, sequences and software. Patients from the Principle Investigator's exam schedule are given the opportunity to participate in…
- Conditions
- Multiple MRI Exams, Including, Cardiac, Abdominal, Lumbar
- Trial name
- NCT01598766
- Testing
- 16 Channel SPEEDER Flex Coil
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Toshiba America Medical Systems, Inc.
Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine
Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine
The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.
- Trial name
- NCT02684045
- Where
- 2 sites in United States
- Volunteers
- 76 people
- Sponsor
- Medtronic Spinal and Biologics
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
Scoliosis, Scoliosis; Adolescence
Study Comparing the PathKeeper System for Pedicle Screw Positioning in Spine Surgery With Traditional Care
The goal of this is to evaluate performance of the Pathkeeper Surgical System. The main question[s]it aims to answer are: 1) evaluate pedicle screw position Participants will in compare Experimental arm: PathKeeper System (PKS)…
- Conditions
- Scoliosis, Scoliosis; Adolescence, Scoliosis Kyphosis, Scoliosis Lumbar Region
- Trial name
- PKSforPSP (NCT06554093)
- Testing
- Medical Device - PKS
- Where
- United Kingdom
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Deep Health Ltd.
Spinal Muscular Atrophy, Spine Deformity
Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy
The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA).
- Conditions
- Spinal Muscular Atrophy, Spine Deformity, Scoliosis
- Trial name
- PIERRE (NCT05866419)
- Testing
- ThecaFlex DRx System
- Where
- 21 sites in United States, Germany and 3 more
- Volunteers
- 90 people
- Sponsor
- Alcyone Therapeutics, Inc
Degenerative Disc Disease
CHARITE™ vs. ALIF 5-Year Follow-up
To assess the clinical and radiographic outcomes through 5-years following treatment with CHARITÉ™ Artificial Disc vs. the BAK Cage for treatment of degenerative disc disease at one level (L4-S1).
- Trial name
- NCT00215332
- Testing
- CHARITE
- Where
- 10 sites in United States
- Volunteers
- 367 people
- Sponsor
- DePuy Spine
Primary Body Region (Arranged Most Common to Least), Lumbar/SI
ATI Evidence-based Guide Investigating Clinical Services
The goal of this study is to evaluate how standard-of-care outpatient rehabilitation is delivered and how variation in care delivery mechanisms relates to clinical outcomes, service utilization, and value in patients receiving…
- Conditions
- Primary Body Region (Arranged Most Common to Least), Lumbar/SI, Knee, Shoulder
- Trial name
- AEGIS (NCT02285868)
- Where
- United States
- Volunteers
- 4,000,000 people, healthy volunteers welcome
- Sponsor
- ATI Holdings, LLC
Spinal Stenosis
Post-Approval Clinical Trial Comparing the Long Term Safety and Effectiveness Coflex vs. Fusion to Treat Lumbar Spinal Stenosis
Post-Approval Clinical Study Comparing the Long Term Safety and Effectiveness of coflex vs. Fusion to Treat Lumbar Spinal Stenosis
- Trial name
- NCT00534235
- Testing
- Decompression, Posterolateral Fusion and Implantation of Pedicle Screws, Implantation of coflex Interlaminar Technology
- Volunteers
- 322 people
- Sponsor
- Paradigm Spine
Meningitis/Encephalitis
QIAstat-Dx® Meningitis/Encephalitis Panel Performance Evaluation Study 001
Study for performance evaluation of the QIAstat-Dx® Meningitis/Encephalitis Panel in comparison with other chosen comparator methods.
- Trial name
- NCT05092438
- Where
- United Kingdom
- Volunteers
- 595 people
- Sponsor
- QIAGEN Gaithersburg, Inc
Degenerative Disc Disease Lumbar, Spondylolisthesis, Grade 1
PMCF Study Fortilink-TS Ti
This study is setup to be able to gather information on the safety and performance of the Fortilink-TS Ti cage of Paradigm Spine GmbH, up to one-year after the surgery.
- Trial name
- NCT07834736
- Testing
- Posterior lumbar interbody fusion surgery
- Where
- 2 sites in Spain
- Volunteers
- 50 people
- Sponsor
- BAAT Medical Products B.V.
Spine Fusion, Spinal Deformity
Clinical Safety and Efficacy of S53P4 Bioactive Glass Putty in Spinal Fusion Surgery
A retrospective, single-tertiary centre observational study. The study population consists mainly of patients with instrumented posterolateral spine fusion operated at the Department of Neurosurgery or at the Department of…
- Trial name
- NCT05001893
- Testing
- S53P4 bioactive glass putty
- Where
- Finland
- Volunteers
- 500 people
- Sponsor
- Bonalive Biomaterials Ltd
Hunter Syndrome
Collection and Study of Cerebrospinal Fluid in Patients With Hunter Syndrome
The purpose of the study is to collect data on CSF biomarkers in patients with Hunter Syndrome that would serve as reference data for comparison with cognitively impaired patients with Hunter syndrome, patients with other…
- Trial name
- NCT01449240
- Testing
- No treatment
- Where
- 7 sites in United States, United Kingdom
- Volunteers
- 10 people
- Sponsor
- Shire
Osteogenesis Imperfecta
Multicenter,Single-arm Study to Evaluate Efficacy, Safety, & Pharmacokinetics of Denosumab in Children w/ OI
This is a prospective, multicenter, single-arm study in children 2 to 17 years of age with OI to evaluate efficacy and safety of denosumab.
- Trial name
- OI (NCT02352753)
- Testing
- Denosumab
- Where
- 49 sites in United States, Australia and 11 more
- Volunteers
- 153 people
- Sponsor
- Amgen
Spinal Disease
NOC2 Spine Registry
The primary objective of the Spine Registry is to enhance the understanding of spinal disease and treatment of spinal disease with the goal of guiding treatment options.
- Trial name
- NCT02187666
- Where
- United States
- Volunteers
- 10,000 people
- Sponsor
- DC2 Healthcare