This is a multi-center, prospective, outcomes study. In this study, the Zero-P PEEK implant will be used in patients undergoing ACDF for treatment of SCDD at a single level between C3 and C7. The cohort will be followed over time to twenty-four (24) months after surgery. Up to fifteen (15) sites will participate in this study. This is not a controlled study.
This was a post-market study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7.
Neurospine, South East Alabama Medical Center
Dothan, Alabama, United States
Barrow Neurosurgical Institute
Phoenix, Arizona, United States
Newport Orthopaedics, Hoag Hospital
Assessment of Neck Disability Index Scores
Percentage of subjects who experienced a maintenance or improvement according to measures of pain and/or function.
Time frame: 24 months
Improvement in the Neck and Arm Visual Analog Pain Scale (VAS)
Percentage of subjects who experienced a maintenance of improvement in VAS neck pain intensity, neck pain frequency, arm pain intensity, and/or arm pain frequency.
Time frame: 24 months
Implant Related Complications
Percentage of subjects who had an implant related complication
Time frame: 24 months
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Newport Beach, California, United States
Lyerly Neurosurgery Group
Jacksonville, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Indiana Spine Center
Lafayette, Indiana, United States
The Boston Spine Group
Newton, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
Sierra Neurosurgery Group
Reno, Nevada, United States
Reno Orthopaedic Clinic
Reno, Nevada, United States
...and 4 more locations