Overview
This is a real world data collection observational study at a single site. There are both prospective and retrospective cohorts. The study will examine the safety and effectiveness of the Synergy cervical disc system in patients with degenerative cervical disc disease.
Eligibility
Inclusion Criteria:
Age 21 or above at the time of the surgery. Have had (retrospective cohort) or the decision
has been made to have (prospective cohort) the Synergy Disc implanted Skeletally mature
patients for reconstruction of the disc from C3-C7 following a single or multiple level
discectomy for intractable radiculopathy
Intractable radiculopathy and/or myelopathy with at least one of the following producing
symptomatic nerve root and/or spinal cord compression:
herniated disc and/or osteophyte formation Symptomatic nerve root and/or spinal cord
compression documented by patient history (arm or neck pain and/or neurologic deficit) and
imaging (CT, MRI, x-rays, etc.) Failed a minimum of 6 weeks conservative treatment Written
informed consent given by subject.
Exclusion Criteria:
Moderate to advanced spondylosis Diagnosis of osteoporosis Active systemic infection or
infection at the operative site Pregnancy Marked cervical instability on lateral, coronal,
or flexion/extension radiographs Cervical spine condition other than symptomatic cervical
disc disease requiring surgical treatment at the involved level Severe pathology of the
facet joints of the involved vertebral bodies Previous diagnosis of osteopenia or
osteomalacia More than one immobile vertebral level between C1 and T1 from any cause Morbid
obesity Vulnerable person (pregnant patients, emergency cases, children, prisoners and
people without mental capacity)-