The purpose of the pivotal IDE clinical study was to evaluate the safety and effectiveness of the SECUREĀ®-C Cervical Artificial Disc for the treatment of symptomatic cervical disc disease at one level between C3 and C7, compared to anterior cervical discectomy and fusion.
The purpose of the Postmarket Approval Study is to evaluate the long-term safety and efficacy associated with the use of the SECURE-C Cervical Artificial Disc
Who can participate
Age range18 Years ā 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Symptomatic cervical disc disease (SCDD) in one vertebral level between C3-C7, defined as neck or arm (radicular) pain, or functional or neurological deficit and radiographic confirmation (by CT, MRI, X-ray, etc.) of any of the following:
* Herniated nucleus pulposus;
* Radiculopathy or myelopathy;
* Spondylosis (defined by the presence of osteophytes); or
* Loss of disc height.
* Age between 18 and 60 years
* Failed at least 6 weeks of conservative treatment
* Neck Disability Index (NDI) Questionnaire score of at least 30 (as percentage of 50 point total)
* Able to understand and sign informed consent form
* Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and filling out forms
* Able to meet the proposed follow-up schedule at 6 weeks, 3 months, 6 months, 12 months and 24 months
* Able to follow postoperative management program
Exclusion Criteria:
* More than one vertebral level requiring treatment
* Prior fusion surgery adjacent to the vertebral level being treated
* Prior surgery at the level to be treated
* Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma
* Radiographic confirmation of facet joint disease or degeneration, defined as apparent sclerosis and/or hypertrophy of the facets demonstrated on AP radiographs as a disruption of the normally smooth facet curve
* Marked cervical instability on resting lateral or flexion/extensioā¦