Abstract
Background: A novel, elastomeric total cervical disc replacement is currently undergoing clinical evaluation in an MHRA approved Multicentre European study. At the time of abstract submission seven patients have been implanted with the device. The device is a two component one consisting of an inner core of medical grade silastic enveloped in an outer jacket of embroidered polyester that replicates the annulus, posterior and anterior longitudinal ligaments.
Methods: The pre-clinical testing of the device included biomechanical, biocompatibility and mechanical fatigue testing have previously been reported at the 2002 Spine Arthroplasty Society meeting in Montpellier. At the time of abstract submission seven patients have been implanted with the device. The clinical trial is a prospective, non-randomized observational study. Patients are followed for a period of two years. VAS pain scores, SF36, NDI and European myelopathy scores, patient satisfaction and detailed radiographic assessments are collected preoperatively, at 4 weeks, 3 months, 6 months, 1 and 2 years postoperatively.
Results: Seven patients (2 female, 5 male) have been implanted at the time of abstract submission. All cases were single level surgeries (C3/C4-1, C5/C6-2, C6/C7-4). Operation time ranged from 55-104 minutes. Blood loss averaged less than 15mls. The NeoDisc implant is very straightforward to implant with no special instrumentation. The lack of any metal components has allowed postoperative MRI and CT scanning to be performed with virtually no artefact present and excellent visualisation of cord and root detail. All patients reported pain intensity reductions. Pain decreased from 4.6 to 1.4 for neck pain and from 6.5 to 0.9 for arm pain on a 10-point scale.
Conclusion: A clinical success rate of 83% was achieved (clinical success being defined as a patient rating of excellent or very good on a 6-point patient self-scoring outcome scale).
The abstracts were prepared by Mr Colin E. Bruce. Correspondence should be addressed to Colin E. Bruce, Consultant Orthopaedic Surgeon, Alder Hey Children’s Hospital, Eaton Road, Liverpool, L12 2AP.
