Stopped: Stryker has made the decision to remove the Rhine Cervical Disc Replacement from their product portfolio. Stryker is not aware of any safety or effectiveness concerns and this decision is not related to poor patient outcomes or known device failures.
A Prospective, open label, multi-center observational study of patients requiring surgical treatment at one or two (contiguous) cervical spine levels. The primary objectives of the RHINE Cervical Disc study are to: obtain operative data and feedback on surgical instruments and surgical technique; confirm device performance in terms of clinical and radiographic outcomes; confirm device performance in terms of safety and to collect original data to be compared to published reports of the performance of comparable motion-sparing devices, as well as clinical outcomes of fusion devices.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Neck Disability Index (NDI) change from baseline
Timeframe: Pre-operative, 6 months, 12 months, 24 months and 60 months
Radiographic Outcomes
Timeframe: Pre-operative, 6-12 weeks, 6 months, 12 months, 24 months and 60 months
Number of Patients with Adverse Events (AEs)
Timeframe: Up to 6-12 weeks post-discharge , 6 months, 12 months, 24 months annd 60 months