Actively enrolling and upcoming studies

Sponsor Title Site Eligibility

PI/Co-PI
Sub-Investigators

Globus, Inc Does the type of procedure affect the incidence of dysphagia and dysphonia in ACDF patients? Cervical

One level ACDF

Radomized Trial of Globus Coalition vs Colonial + Providence using Autogenious Bone Material

Kim
Klineberg, Roberto

Mesoblast MSB-CF002 Multi-level ACDF using NeoFuse with MasterGraft. Phase 1b/2a Cervical

Two or three level ACDF

Randomized Trial of NeoFuse (MPC's) plus Mastergraft Matrix vs cervical allograft spacer control

Kim/Klineberg
Roberto

 Mesoblast MSB-DR003 Lumbar Disc Rengeration Study  Lumbar 

Chronic low back pain > 6 months due to DDD at one level L1 to S1 and failed three months of conservative therapy

Randomized trial of single injetion of MPC's (high dos vs low dose) combined with hyaluronic acid (HA) vs. control injection (HA vs. saline) into symptomatic disc 

Kim/Scott Fishman
Klineberg, Roberto 

Lanx, Inc. Randomized study of ASPEN (R) Spinous Process System vs Pedicle screws in ALIF  Lumbar 

One level ALIF with posterior fixation

Randomized Trial of Aspen vs Pedicle screws 

Kim
Klineberg 

AOSpine Efficacy of Riluzole in Patient with Cerical Spondylotic Myelopathy Undergoing Surgical Treatment   Cervical

Cervical myelopathy undergoing surgical decompression

Randomized trial of Riluzole, 50 mg bid vs placebo 14 days prior to surgery through 28 days postop.

Kim/Klinesberg
Roberto, Gupta 

Covidien DuraSeal Exact Spine Sealant Post-Approval Study  Dural openings 

Planned or incidental dural openings

Prospective: planned or incidental use of DuraSeal Exact during surgery
Retrospective: any method other than DuraSeal Exact used for planned or inciental dural opening. Surgery occured < 24 mo from study initiation visits.

Kim/Boggan
Gupta 

 Asubio-SUN SUN13837 Injection for acute spinal cord injury  Cervical 

Closed single traumatic SCI between C4 through C7. Must receive first dose of druge within 12 hours of injury.

Randomized trial of SUN13837 injection vs placebo x 28 days. 

Kim/Klineberg
Roberto, Gupta 

Ethicon A Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair
(ClinicalTrials.gov identifier: NCT02457546)
Cranial

Patients at least 18 years of age undergoing craniotomy or craniectomy surgery

Boggan

Federal Grant Fluorescence Lifetime Technique for Detection of Radiation Necrosis vs. Cancer Recurrence
(ClinicalTrials.gov identifier: NCT01981148)
Brain

Diagnosis of metastatic cancer or any grade of glioma in which the diagnosis of possible tumor progression, recurrence or radiation necrosis has been made.

Boggan

InVivo The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-
Spinal ScaffoldTM for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury
(ClinicalTrials.gov identifier: NCT02138110)
Thoracic

Patients age 16 – 70 years who are newly diagnosed with a T2- T12/L1 (neurological level) functionally complete spinal cord injury (AIS A) and are scheduled for spinal stabilization surgery within 96 hours after the initial injury.

Kim

InVivo Pilot Study of Clinical Safety and Feasibility of the Neuro-Spinal ScaffoldTM for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury at the C5-T1 Neurological Levels
(ClinicalTrials.gov identifier: NCT  TBD)
Cervical

Patients age 16 – 70 years who are newly diagnosed with a C5-T1 (neurological level) complete  spinal cord injury and are scheduled for spinal stabilization surgery within 96 hours after the initial injury.

Kim

Vertex A Phase 2b/3, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
(ClinicalTrials.gov identifier: NCT0266984)
Cervical

Patients 14 - 75 years of age who are newly diagnosed with acute traumatic cervical spinal cord injury and are scheduled for spinal stabilization surgery within 72 hour after the initial injury.

Kim

Mesoblast A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of a Single Injection of rexlemestrocel-L Alone or Combined with Hyaluronic Acid (HA) in Subjects with Chronic Discogenic Lumbar Back Pain Through 12 Months
(ClinicalTrials.gov identifier: NCT0241273)
Lumbar

Patients at least 18 years of age with chronic low back pain (> 6 months duration) not adequately controlled by conservative measures and associated with moderate radiographic degenerative changes of a disc.

Kim

Orthofix Safety and Efficacy of Pulsed Electromagnetic Fields (Cervical-Stim®) as an Adjunct to Enhance Union in Conservatively Treated Type II Fractures of the Odontoid Process
(ClinicalTrials.gov identifier: NCT02281994)
Spine

Patients 50 years or older who have sustained a fracture of the odontoid process and who are not surgical candidates.

Kim

Spineguard Prospective randomized evaluation of intra-operative three dimensional image (O-arm) based navigation and PediGuard based technique for thoracolumbar pedicle screw insertion Spine

Patients at least 18 years of age who are undergoing multi-level thoracic/lumbar fixation surgery of the spine.

Panchal

 

Updated October 2012