Status: This trial has been completed.
The study is a multi-center, prospective, randomized controlled clinical trial that will compare the safety and effectiveness of the CerviCore™ Intervertebral Disc to anterior cervical discectomy and fusion (ACDF) with a rigid plate for radicular symptoms associated with loss of disc height, disc/osteophyte complex, or herniated disc at a single cervical spine level. The trade name of the investigational device is CerviCore™ Intervertebral Disc.
The objective of this clinical investigation is to compare the safety and effectiveness of the CerviCore™ to ACDF surgery in the treatment of cervical radicular symptoms (upper extremity pain and/or neurological deficit) associated with loss of disc height, disc/osteophyte complex, or herniated disc at a single level between C3 and C7.
Stryker Spine, Allendale, NJ
Inclusion criteria (key criteria):
Exclusion criteria (key criteria):
Caution: Investigational device limited by United State law to investigational use. If you think you might be a candidate for this clinical trial, contact us for more information or fill out and submit our online forms.