A Prospective Clinical Evaluation of the Centinel Spine™ STALIF C® No Profile® Integrated Interbody Fusion™ Device
Aims: This is a postmarket 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). This study is designed to better understand the links between conservative care, spinal fusion and patient outcomes.
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
Clinical Study Protocol for the Investigation of the Simplify® Cervical Artificial Disc
Aims: This nonrandomized study evaluates the safety and effectiveness of the Simplify Disc 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 patients 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 have not responded to at least six weeks of nonsurgical care such as physical therapy, medicines or injections or have increasing symptoms, such as numbness or tingling, and/or who have signs of nerve compression in the part of the nerves that branches 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
Co-Investigators: Mark Nolden, MD and Noam Stadlan, 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 Real 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 have 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