Comparison of Early Fusion Using a NanoMetalene® Implant Versus Both PEEK and Allograft Implants in Anterior Cervical Discectomy and Fusion (ACDF) With OsteoStrand™ Demineralized Bone Fibers
Status: Suspended
Location: See all (11) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
A prospective, multi-center, randomized, self-controlled, single-blinded, clinical study evaluating the NanoMetalene implant as compared to the PEEK and allograft implants in ACDF for the treatment of cervical degenerative disc disease (DDD).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Cervical degenerative disc disease
• Requires primary spinal fusion from C3-C7
• Minimum of 6 weeks of non-operative treatment
• Signed informed consent form
Locations
United States
Arizona
Barrow Brain and Spine
Phoenix
California
University of California, San Diego
La Jolla
University of Southern California
Los Angeles
UCLA Health
Santa Monica
Colorado
University of Colorado Hospital
Aurora
Spine Colorado
Durango
Georgia
Emory
Atlanta
Hughston Clinic
Columbus
Illinois
Northwestern University
Chicago
Indiana
OrthIndy
Indianapolis
Michigan
Henry Ford
Jackson
Time Frame
Start Date: 2018-11-18
Completion Date: 2021-01-30
Participants
Target number of participants: 18
Treatments
Other: NanoMetalene/PEEK
Other: NanoMetalene/Allograft
Authors
Christopher MJ Cain, Keith Michael, Daniel C Lu, Nader Dahdaleh, Jay Turner, Erik Olsson, Jim Youssef, Douglas Orndorff, Azam Basheer
Related Therapeutic Areas
Sponsors
Leads: SeaSpine, Inc.