A Prospective Clinical Evaluation of the Centinel Spine™ STALIF C® No Profile® Integrated Interbody Fusion™ Device
Aims:
This is a post-market analysis study of FDA-approved cervical fusion devices: The STALIF C, and STALIF C-Ti. The purpose of this study is to collect information about how well different types of patients do after spinal fusion, based on their earlier treatments (conservative therapy). Spinal fusion is recognized as the standard treatment for patients with Degenerative Disc Disease (DDD) that have failed conservative therapy. It is not clear which patients will do well with conservative therapy and which patients will not. Further, it is not fully understood which patients will do best with spinal fusion. This study is designed to better understand the links between conservative care, spinal fusion and patient outcomes. Patients’ participation in this study involves the collection of data associated with standard of care procedures and follow-up. It does not involve anything special in regard to the surgical procedure or follow-up care.
Principal Investigator: Michael Musacchio, MD
NorthShore Project Number: EH15-059
Contact: Please call 847.570.4224 with questions regarding the study
Open to enrollment: Yes

Single Level: Clinical Study Protocol for the Investigation of the Simplify ® Cervical Artificial Disc”
Aims: This non-randomized study evaluates the safety and effectiveness of the SimplifyDisc for patients who are undergoing a discectomy (removal of a cervical disc) at one level due to arm pain and/or neurological symptoms (such as weakness or numbness). The study is for patient with or without neck pain who have specific findings on imaging studies such as X-ray, CT, or MRI. The study is for patients who have tried, but not responded to at least six weeks of non-surgical care such as physical therapy, medicines, or injections or have increasing symptoms, such as numbness or tingling, and/or have signs of nerve compression in the part of the nerves that branch out from the spinal cord. This research study will compare outcomes after surgery with the Simplify Disc to historical outcomes after anterior cervical discectomy and fusion (ACDF) surgery.
Principal Investigator: Michael Musacchio, MD
NorthShore Project Number: EH16-125
Contact: Please call 847.570.4224 with questions regarding the study
Open to Enrollment: Yes

A 2 and 5  year  comparative  evaluation  of  clinical  outcomes  in  the treatment  of degenerative spinal  stenosis  with  concomitant  low back pain by decompression with and without additional stabilization using the coflex® Interlaminar Technology for FDA Conditions of Use Study.
Aims: This is a prospective, multicenter, randomized, controlled and patient-blinded study with the purpose of demonstrating the safety and effectiveness of the coflex® device in conjunction with surgical decompression relative to decompression alone. The study is for patients from 40 to 80 years of age who have tried, but not responded to at least one epidural injection at any prior time point, and at least 6 months of prior conservative care without adequate and sustained symptom relief. The coflex® Interlaminar Technology is intended for use as a permanent implant between the lamina of 1 or 2 lumbar motion segments in the treatment of at least moderate leg and low back pain in patients with moderate to severe spinal stenosis. The device is specifically designed to provide stabilization without fusion in cases of stenosis. It is restricted for use to one or two levels in the region of L1 – L5. This research study will compare and evaluate 2 and 5-year clinical outcomes of patients implanted with the coflex® device in conjunction with surgical decompression with those treated with decompression alone.
Principal Investigator: Michael Musacchio, MD
NorthShore Project Number: EH16-184
Contact: Please call 847.570.4224 with questions regarding the study
Open to Enrollment: Yes