Clinical Trials

Active Clinical Trials

Pfizer “STRIVE” Vaccine Study

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Staphylococcus Aureus 4-Antigen Vaccine (SA4Ag) in Adults Undergoing Elective Open Posterior Spinal Fusion Procedures with Multilevel Instrumentation

Sponsor: Pfizer, Inc.
2017 – Present
Status: Enrolling

The purposes of this clinical trial are to determine whether the SA4Ag vaccine can prevent postoperative Staphylococcus aureus infections in patients who are undergoing elective spinal fusion surgery and to evaluate the safety of SA4Ag in patients who undergo elective spine surgery. Approximately fifty patients at New Jersey Medical School are expected to participate in this trial.

CSM-S Trial

Cervical Spondylotic Myelopathy Surgical Trial

Sponsor: Lahey Clinic, Patient-Centered Outcomes Research Institute (PCORI)
2014 – Present
Status: Enrollment Complete/Active Follow-Up

The purpose of this study is to determine the optimal surgical approach (ventral vs. dorsal) for patients with multilevel cervical spondylotic myelopathy (CSM) as there are currently no established guidelinesfor the management of patients with CSM. CSM is the most common cause of spinal cord injury and dysfunction in the U.S. and the world.Fifteen patients enrolled in this trial at NJMS.

InVivo “INSPIRE” Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury

Sponsor: InVivo Therapeutics, Inc.
2015 – Present
Status: Enrollment on Hold

This device study is being performed to evaluate whether the neuro-scaffold™ is safe and whether it demonstrates probable benefit for the treatment of complete T2-T12/L1 spinal cord injury. The trial is being conducted in support of future studies and an HDE application with subsequent approval.

Recent Clinical Trials

P-15 Bone Putty

An Assessment of P-15 Bone Putty in Anterior Cervical Fusion with Instrumentation

Sponsor: Cerapedics, LLC.
2007 – 2017
Status: Closed

This randomized, controlled, multi-center, prospective FDA IDE study was conducted to assess the safety and effectiveness of i-FACTOR™ bone graft in patients treated with single level ACDF. Patients were followed for six years post-surgery.

Discover

A Multi-Center, Prospective Randomized Controlled Trial Comparing Cervical Arthroplasty to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Cervical Degenerative Disc Disease (DDD)

Sponsor: DePuy Spine, Inc.
2006 – 2015
Status: Closed

This IDE Study compared the use of the Discover artificial cervical disc replacement to anterior cervical discectomy and fusion in one and two level spine surgeries for treatment of cervical degenerative disc disease.