ObjectiveTo evaluate the effectiveness of the single segmental cervical disc replacement with ProDisc-C, and to explore the location change of the flexion/extension center of rotation (COR) of the target level as well as its clinical significance. MethodsBetween June 2010 and February 2012, 23 patients underwent single segmental cervical disc replacement with ProDisc-C, and the clinical data were retrospectively analyzed. Of 23 patients, 9 were male, and 14 were female with the age range from 27 to 65 years (mean, 45 years), and the disease duration ranged from 10 to 84 months (mean, 25 months). There were 15 patients with radiculopathy, 5 patients with myelopathy, and 3 patients with mixed cervical spondylosis. The involved segments were C4,5 in 5 cases, C5,6 in 14 cases, and C6,7 in 4 cases. Japanese Orthopaedic Association (JOA) score and neck disability index (NDI) were adopted to evaluate the effectiveness. Preoperative and Postoperative radiographic parameters, such as cervical overall range of motion (ROM), target segmental ROM, the adjacent segmental ROM, and intervertebral height were compared. Besides, the location changes of the COR of the target level were further analyzed by the alteration of its coordinates (COR-X,COR-Y), and the relationships between the location changes of the COR and the effectiveness or the radiographic results were analyzed. ResultsAll the operations were completed successfully; 1 case had hoarseness after operation, which disappeared at 3 months after operation. All cases were followed up 18.3 months on average (range, 6-36 months). There was no device migration, loosening, subsidence, or fracture at last follow-up. The JOA score increased significantly and the NDI score decreased significantly at last follow-up when compared with preoperative scores (P<0.05). No difference was found in the cervical overall ROM, target segmental ROM, the adjacent segmental ROM, and the COR-Y of the target level between pre-operation and last follow-up (P>0.05); while the intervertebral height and the COR-X increased significantly (P<0.05). The change of the COR-X had no obvious correlation with the postoperative JOA, NDI, and target segmental ROM (P>0.05). According to whether the difference of the COR-X between pre- and post-operation was less than the average value 1.86 mm or not, the patients were divided into 2 groups; significant difference was shown in the postoperative target segmental ROM between 2 groups (P<0.05), but no significant difference was found in the postoperative JOA、NDI, cervical overall ROM, adjacent segmental ROM, and the intervertebral height between 2 groups (P>0.05). ConclusionSingle segmental cervical disc replacement with ProDisc-C can obtain satisfactory outcomes. The cervical overall ROM, target segmental ROM, and adjacent segmental ROM can be effectively maintained, and the intervertebral height is increased. The location of the flexion/extension COR of the target segment shifts forward after insertion of the ProDisc-C prosthesis, and the postoperative target segmental ROM becomes smaller as the distance of the displacement of the COR becomes greater.
Objective To analyze the distribution of stress in the upper and lower plates of the prosthesis-bone interface, and the effect of interface pressure on osseointegration. Methods CT scanning was performed on goats at 1 week after artificial cervical disc replacement to establish the finite element model of C3, 4. The stress distribution of the upper and lower plates of the interface was observed. At 6 and 12 months after replacement, Micro-CT scan and three dimensional reconstruction were performed to measure the bone volume fraction (BVF), trabecular number (Tb. N), trabecular thickness (Tb. Th), trabecular separation (Tb. Sp), bone mineral density (BMD), bone surface/bone volume (BS/BV), and trabecular pattern factor (Tb. Pf). The C3 lower plate and C4 upper plate of 4 normal goat were chosen to made the cylinder of the diameter of 2 mm. The gene expressions of receptor activator for nuclear factor κB ligand (RANKL), osteoprotegerin (OPG), transforming growth factor β (TGF-β), and macrophage colony-stimulating factor (M-CSF) were detected by real time fluorescent quantitative PCR at immediate after cutting and at 24 and 48 hours after culture. The samples of appropriate culture time were selected to made mechanical loading, and the gene expressions of RANKL, OPG, M-CSF, and TGF-β were detected by real time fluorescent quantitative PCR; no mechanical loading samples were used as normal controls. Results Under 25 N axial loading, the stress of the upper plate of C3, 4 was concentrated to post median region, and the stress of the lower plate to middle-front region and two orbits. According to stress, the plate was divided into 5 regions. The Micro-CT scan showed that BMD, Tb.Th, BVF, and Tb.N significantly increased, and BS/BV, Tb.Sp, and Tb.Pf significantly decreased at 12 months after replacement when compared with ones at 6 months (P<0.05). At 24 and 48 hours after culture, the gene expressions of RANKL, OPG, and TGF-β were signifi-cantly higher than those at immediate (P<0.05), but no significant difference was found between at 24 and 48 hours after culture (P>0.05). The mechanical loading test results at 24 hours after culture showed that the RANKL and OPG gene expressions and OPG/RANKL ratio in C3 lower plate and C4 upper plate were significantly up-regulated when compared with controls (P<0.05), but no significant difference was shown in TGF-β and M-CSF gene expressions (P>0.05). Conclusion Domestic artificial cervical disc endplate has different pressure distribution, the stress of lower plate is higher than that of upper plate. Pressure has important effect on local osseointegration; the higher pressure area is, the osseointegration is better. Under the maximum pressure in interface, the osteoblast proliferation will increase, which is advantageous to the local osseointegration.