Upstate Active Clinical Trials
Study Title:Prospective, Concurrently Controlled, Multi-Center Study to Evaluate the Safety and Effectiveness of the Spinal Kinetics(TM) M6-C Artificial Cervical Disc Compared to Anterior Cervical Discectomy and Fusion (ACDF) for the Treatment of Symptomatic Cervical Radiculopathy
What is the purpose of the study? (in Layman's terms, please describe the study)The ACDF study arm is to provide a comparison group to see if the M6-C artificial cervical disc (an investigational or experimental device) is safe and effective (successful) in treating the continued neck/arm pain and nerve or spinal cord irritation that results from the discs (the spongy part between the bones in your neck called vertebral bodies) in your spine not working properly. To determine if the M6-C device is safe and effective, the clinical results from the M6-C arm of the study will be compared to the results from subjects that undergo an Anterior Cervical Discectomy and Fusion (ACDF) procedure in the other arm of this study that is happening at the same time. This site is conducting the control arm of the study, you will receive an ACDF, which is not investigational.
Upstate Institutional Review Board (IRB) Number:627151
Patient Age Group:Adults
Principal Investigator:William F Lavelle, MD
What is involved if I participate?
- How long is the study?
- Is transportation provided or reimbursed?
- Is parking provided or reimbursed?
Where will the study take place?Upstate Bone and Joint Center, 6620 Fly Rd., East Syracuse
Who can I contact for more information?
Name: Tina M Craig