Cervical spine disc prosthesis: radiographic, biomechanical and morphological post mortal findings 12 weeks after implantation. A retrieval example

Abstract

There is a gap between in vitro and clinical studies concerning performance of spinal disc prosthesis. Retrieval studies may help to bridge this gap by providing more detailed information about motion characteristics, wear properties and osseous integration. Here, we report on the radiographic, mechanical, histological properties of a cervical spine segment treated with a cervical spine disc prosthesis (Prodisc C, Synthes Spine, Paoli, USA) for 3 months. A 48-year-old male received the device due to symptomatic degenerative disc disease within C5-C6. The patient recovered completely from his symptoms. Twelve weeks later, he died from a subarachnoid hemorrhage. During routine autopsy, C3-T1 was removed with all attached muscles and ligaments and subjected to plain X-rays and computed tomography, three dimensional flexibility tests, shear test as well as histological and electronic microscopic investigations. We detected radiolucencies mainly at the cranial interface between bone and implant. The flexibility of the segment under pure bending moments of +/-2.5 Nm applied in flexion/extension, axial rotation and lateral bending was preserved, with, however, reduced lateral bending and enlarged neutral zone compared to the adjacent segments C4-C5, and C6-C7. Stepwise increase of loading in flexion/extension up to +/-9.5 Nm did not result in segmental destruction. A postero-anterior force of 146 N was necessary to detach the lower half of the prosthesis from the vertebra. At the polyethylene (PE) core, signs of wear were observed compared to an unused core using electronic microscopy. Metal and PE debris without signs of severe inflammatory reaction was found within the surrounding soft tissue shell of the segment. A thin layer of soft connective tissue covered the major part of the implant endplate. Despite the limits of such a case report, the results show: that such implants are able to preserve at least a certain degree of segmental flexibility, that direct bone implant contact is probably rare, and that debris may be found after 12 weeks.