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Objective: To assess the safety, clinical stability and capacity to preserve motion in the cervical spine of a newly designed cervical intervertebral disc replacement for patients with degenerative disc disease.
Design: A prospective cohort pilot study.
Subjects: Fifteen patients considered to be at risk of developing adjacent level degenerative changes received the artificial joint. Patients had either radiculopathy and/or myelopathy with radiological evidence of compression.
Outcome Measures: Radiological evidence of stability of the device and preservation of motion at the operated level and adverse events associated with the procedure. Secondary outcome measures were changes in scores on SF-36, Neck Disability Index, European Myelopathy Score and Visual Analogue Pain Scale assessments.
Results: The artificial joint maintained motion at the operated in all patients. The procedure was considered safe to be performed by experienced spine surgeons. The device was stable with no dislocation of components or backing out of screws. Improvements were noted in all of the assessment scores though statistical significance was not achieved.
Conclusions: Cervical intervertebral motion can be maintained with this device which at two years is clinically stable. The long-term influence of this device remains unknown.