Clinical trials: Spine
Intracranial Surgery, Extracranial Surgery
Product Surveillance Registry; Ear, Nose &Amp; Throat - NIM Vital Cohort
The purpose of this study is to confirm clinical safety and performance of Medtronic's NIM Vital™ System and accessories when used as intended in a real-world setting.
- Conditions
- Intracranial Surgery, Extracranial Surgery, Intratemporal Surgery, Extratemporal Surgery
- Trial name
- PSR-ENT (NCT06637995)
- Testing
- Intraoperative Nerve Monitoring
- Where
- Germany
- Volunteers
- 205 people
- Sponsor
- Medtronic
Degenerative Spine Disease
FIBERGRAFT Aeridyan Posterolateral Fusion Study
This is a post-market, prospective, controlled, multicenter clinical study to evaluate radiographic fusion and clinical outcomes of FIBERGRAFT™ Aeridyan Matrix bone graft substitute in subjects who undergo a 1-3 level…
- Trial name
- NCT07059065
- Testing
- FIBERGRAFT™ Aeridyan Matrix Bone Graft Substitute, Demineralized Bone Matrix
- Where
- 5 sites in United States
- Volunteers
- 316 people
- Sponsor
- DePuy Synthes Products, Inc.
Degenerative Disc Disease, Spondylolisthesis
Pilot Study to Assess Safety/Prelimary Effectiveness of Prefix in Subjects With Degenerative Disc Disease (DDD) Undergoing Spine Fusion Surgery
This is a pilot study to evaulate the safety and prelimary effectiveness of Prefix as compared to autogenous bone for spinal fusion procedures in skeletally mature subjects with degenerative disc disease (DDD) at one level from…
- Trial name
- NCT00798239
- Testing
- Prefix (AMPLEX) B2A Peptide Enhanced Ceramic Granules, Iliac crest autograft
- Where
- 5 sites in Canada
- Volunteers
- 24 people
- Sponsor
- BioSurface Engineering Technologies, Inc
Orthopedic Disorder of Spine
Phase III, Evaluate Noninferiority Between Levobupivacaine and Bupivacaine in Spinal Anesthesia.
Clinical trial phase III, noninferiority, controlled, double-blind, randomized. The purpose of this study is to evaluate the noninferiority between Levobupivacaine and Bupivacaine in spinal anesthesia.
- Trial name
- NCT01994967
- Testing
- Levobupivacaine, Bupivacaine
- Where
- 5 sites in Brazil
- Sponsor
- Cristália Produtos Químicos Farmacêuticos Ltda.
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
Surgery
Air Barrier System Device to Reduce Contamination in Posterior Spine Surgery
The objective of this study is to determine whether the Air Barrier System (ABS) reduces airborne colony-forming units (e.g. bacteria) present at surgery sites during posterior spinal procedures
- Trial name
- NCT01559506
- Testing
- Air Barrier System device
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- Nimbic Systems, LLC
Lower Back Pain
Safety and Performance of the Elaspine System in the Treatment of the Lumbar Spine
The safety and performance of the Elaspine™ Implant System in the treatment of lower back pain will be evaluated with a prospective and nonrandomized, multicenter post-marketing clinical study (PMCS).
- Trial name
- NCT01323543
- Testing
- Elaspine™
- Where
- 5 sites in Germany, Switzerland
- Volunteers
- 40 people
- Sponsor
- Spinelab AG
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.
Spine Disease, Spinal Fusion
Validity and Accuracy of a Machine Learning Predictive Model in the Exploitation of Patients Related Outcomes in Spine Surgery
The objective of the study is the establishment, optimization and prospective evaluation of a digital predictive platform capable of providing for each lumbar spine operated patient a clinical predictive status: Patient green…
- Conditions
- Spine Disease, Spinal Fusion, Surgery, Spine Degeneration
- Trial name
- DeepSurgery (NCT05166018)
- Testing
- SuMO Patient
- Where
- 2 sites in France
- Volunteers
- 174 people
- Sponsor
- Cortexx Medical Intelligence
Cervical Spinal Cord Injury, Spine Injury
Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury
This study will evaluate the safety and efficacy of human central nervous system stem cell transplantation into patients with traumatic injury in the cervical region of the spinal cord.
- Conditions
- Cervical Spinal Cord Injury, Spine Injury, Cervical Spine Injury
- Trial name
- NCT02163876
- Testing
- HuCNS-SC cells
- Where
- 14 sites in United States, Canada
- Volunteers
- 31 people
- Sponsor
- StemCells, Inc.
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
Osteoporosis
Transition From Alendronate to Romosozumab (AMG 785)
The purpose of this study is to estimate the percent change from baseline in lumbar spine bone mineral density (BMD) following multiple-dose administrations of romosozumab in postmenopausal women with low BMD previously treated…
- Trial name
- NCT01588509
- Testing
- Romosozumab
- Where
- 9 sites in United States
- Volunteers
- 60 people
- Sponsor
- Amgen
Cervical Spinal Cord Injury, Spine Injury
Dose Escalation Study of AST-OPC1 in Spinal Cord Injury
The purpose of this study is to evaluate the safety of cross sequential escalating doses of AST-OPC1 administered among 5 cohorts at a single time-point between 21 and 42 days post injury, inclusively, to subjects with subacute…
- Conditions
- Cervical Spinal Cord Injury, Spine Injury, Spinal Cord Trauma
- Trial name
- NCT02302157
- Testing
- AST-OPC1
- Where
- 9 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lineage Cell Therapeutics, Inc.
Lumbar Degenerative Disc Disease
Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Adjunct therapy for increasing posterolateral fusion success following single level posterior instrumented lumbar surgery.
- Trial name
- EXO-SPINE (NCT00744861)
- Testing
- Exospine, Exogen 4000+
- Volunteers
- 328 people
- Sponsor
- Bioventus LLC
Osteoporosis
A Study That Will Compare the Effect of Two Drugs on Participants With Low Bone Mass and a Recent Hip Fracture
This study will evaluate whether teriparatide is superior to the active comparator in the change from baseline of lumbar spine BMD (bone mineral density) in men and postmenopausal women with low bone mass and a recent…
- Trial name
- MOVE (NCT00887354)
- Testing
- Teriparatide, Risedronate, Calcium
- Where
- 28 sites in United States, Canada and 10 more
- Volunteers
- 224 people
- Sponsor
- Eli Lilly and Company
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
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.
Acute Low-back Pain, Chronic Low-back Pain
Impact of DuoTherm Compared to TENS on Pain and Disability With Acute and Chronic Low Back Pain
Evaluate pain and disability change in Low Back Pain with DuoTherm Compared to Active Control
- Conditions
- Acute Low-back Pain, Chronic Low-back Pain, Pain, Intractable
- Trial name
- NCT04494698
- Testing
- Duotherm VibraCool Back Device, TENS 8-channel unit
- Where
- 2 sites in United States
- Volunteers
- 160 people
- Sponsor
- MMJ Labs LLC