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.
Study Type
OBSERVATIONAL
Enrollment
50
motion preservation disc
Mater Misericordiae University Hospital
Dublin, Ireland
RECRUITINGNeck Disability Index (NDI)
Neck disability Index improvement of \>15 pts (out of 100) in subjects by 12 months post operative compared with baseline. A lower score is a better score.
Time frame: 12 months
Device Related or Device Procedure Related Adverse Events
Absence of major device related adverse events defined as radiographic failure, neurologic failure or failure by adverse event
Time frame: 12 months
Neck and Arm Pain Measurement
Pain will evaluated by the Visual analog scale (VAS) (place a line from zero where there is no pain to 10 which is the worst pain imaginable), by NRS (circle a number from zero to ten where zero equals no pain and ten is worst imaginable) to or a verbal description that the doctor writes down, per the site's Standard of Care. A change of at least 20 mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up timepoint. Left and Right arm/shoulder pain as measured on a 100 mm VAS at baseline and at each follow up time-point.
Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Patient Satisfaction
patient completed questionnaire on their satisfaction with the disc replacement surgery
Time frame: 6 week, 3 month, 6 month, 12 month, 24 month
Motor and Sensory Function in the Arm
maintenance or improvement in neurologic status compared with baseline will be assessed using a defined numeric scale ranging from 0 (normal) to 5 (deficit)
Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Nurick's Criteria
Disease status as characterized by physician at each time point
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Time frame: pre-operative, 6 week, 3 month, 6 month, 12 month, 24 month
Odom's criteria
surgical outcome characterized by physician at each post operative visit
Time frame: 6 week, 3 month, 6 month, 12 month, 24 month