This trial is a real world data (RWD) collection observational study, comprised of both prospective and retrospective arms, that will examine the safety and effectiveness of the Synergy Cervical Disc System in patients with degenerative cervical disc disease.
Study Type
OBSERVATIONAL
Enrollment
200
motion preservation disc
Greenslopes Private Hospital
Brisbane, Queensland, Australia
RECRUITINGDr. Greg Malham
Melbourne, Victoria, Australia
RECRUITINGSpine and Scoliosis Research Associates Australia Ltd
Windsor, Victoria, Australia
RECRUITINGNeck Disability Index
\>15 improvement in NDI score (out of 100) in subjects by 12 mo. post operative compared with baseline
Time frame: 12 months
Device Related or Device Procedure Related Adverse Events
Absence of major device related adverse events defined as radiographic failure, neurological failure, or failure by adverse event
Time frame: 12 months
Visual Analog (VAS) pain
Visual analogue scale (VAS) will be used to evaluate pain where a change of at least 20mm will be considered clinically significant. Neck pain as measured on a 100mm VAS at baseline and at each follow-up time-point. Left and Right arm/shoulder pain as measured on a 100mm VAS at baseline and at each follow-up time-point.
Time frame: pre-operative and 6 week, 3 months, 6 months, 12 months, annually post operatively
Patient Satisfaction
patient completed questionnaire on satisfaction with disc replacement surgery
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Nurick's Criteria
disease status characterized by physician at each visit
Time frame: pre-operative and 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Odom's Criteria
surgical outcome characterized by physician at each post operative visit
Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively
Neurologic Function
maintenance or improvement in neurologic status compared to baseline
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Time frame: 6 weeks, 3 months, 6 months, 12 months, annually post operatively