Objectives The study aims to evaluate the radiological, clinical efficacy and safety of a novel compressible cervical disc prosthesis in the treatment of degenerative cervical radiculopathy
Design Observational non-randomised case series based in two centres.
Subjects 101 consecutive patients (137 artificial discs) treated for cervical radiculopathy secondary to cervical disc degeneration. Mean age at operation 45.4 years.
Methods Neck Disability Index, Visual Analogue Score for neck and arm pain, Euro Quality of Life −5D survey, index level range of movement, heterotopic ossification, adjacent level disease, re-intervention rate and safety profile were assessed. Clinical (outpatient and telephone questionnaires) and radiological (Nuvaline and McKeeson PACS suites) were employed
Results Index range of movement was 7.9 degrees pre operatively and 7.6 at two years. 2 re operations at supradjacent levels took place post treatment in a 35 month follow-up period. 1 post-operative haematoma and 1 delayed infection occurred. All four primary outcome measures exhibited significant improvement from baseline to last follow up; NDI (47.5 to 24.9, p<0.001) EURO QOL index (0.36 to 0.84, p<0.0001) and VAS Arm (5.6 to 0.85 p<0.0001) and VAS Neck (7.1 to 1.7, p<0.0001).
Conclusions The compressible disc prosthesis preserved 96.2% of the initial range of movement at index level whilst exhibiting a favourable re operation rate and safety profile.
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