BACKGROUND: To describe routine surgical practice using Prestige LP Cervical Disc (Prestige disc) and patient outcomes for degenerative cervical disc disease in a multicenter 2-year prospective, observational study. METHODS: Patient demographics and intraoperative data were collected; quality of life (QoL) (EQ-5D, EQ-VAS, and neck disability index), average disc height, and adverse events were assessed pre- and postoperatively at 3, 6, 12, and 24 months. RESULTS: One hundred and ninety-four patients were enrolled (190 patients implanted; female: 67%; mean age: 44.0 years; mean body mass index: 25.6). Disc herniation was the most frequent indication for cervical arthroplasty (80.5%). Thirty-seven percent of patients experienced pain for >1 year prior to baseline assessment. Mean procedure duration was 87.1 minutes, and mean blood loss was 43.8 mL. The majority (71.0%) of Prestige discs were implanted at level C5 to C6, while 16.3% of patients received implants at 2 levels. There was a significant improvement from baseline to 3, 6, 12, and 24 months of follow-up in all QoL assessments. After implantation, the mean disc height at the affected level increased by 0.19 from baseline (0.22) to 3 months (0.41) and remained constant up to 24 months (P < .001). Mean disc height of levels above and below the implant remained comparable at baseline and follow-up. A total of 63 adverse events (44 patients) was recorded, of which 7 (11.1%) were related to the Prestige disc, instrumentation, or procedure; 41 (65.1%) were unrelated; and 15 (23.8%) had an unknown relation. CONCLUSIONS: In line with published findings, our study shows significant improvement in outcomes in the first 3 months after Prestige disc implantation with improvements maintained throughout the study.

• Keywords
• cervical spine, Prestige LP Cervical Disc, arthroplasty, degenerative disc disease, quality of life,
• Publication type
• Journal Article MeSH

PURPOSE: Recent studies describe significant rates of heterotopic ossification (HO) after cervical total disc replacement (CTDR). Little is known about the reasons, and one aspect that requires further in vivo investigation is the biomechanical alteration after CTDR and the role of the implant-related centre of rotation (CORi) in particular. The role of the sagittal position of the CORi on functional outcome in two versions of a semi-constrained disc prosthesis with sagittally different CORi is the topic of this study. METHODS: Patients were candidates for single-level CTDR between C3 and C7 who suffered from CDDD and received a standard or flat version of activ C™ (Aesculap AG, Tuttlingen). Clinical and radiographic assessments were determined preoperatively, intraoperatively, at discharge and again at 6 weeks, 6 months, 1 and 2 years. Radiographic examinations were performed independently using specialized quantitative motion analysis software. RESULTS: Clinical outcome improved significantly regarding NDI as well as VAS on neck and arm pain with no differences in mean improvement by study group. Segmental angle measures show a significantly better lordotic alignment for both groups after surgery, but the degree of correction achieved is higher in the flat group. Correlation analysis proves that the more anterior the CORi is positioned, the higher the lordotic correction is achieved (Pearson rho -0.385). Segmental ROM decreased in the standard group but was maintained for flat implants. At present, our data do not demonstrate a correlation between CORi and ROM at 2 years. Two years after surgery, severe HO grade III-IV was present in 31.6 % standard and 13.1 % flat cases with significant differences. Grouping according to HO severity showed comparable sagittal positions of CORi for flat implants but a more posterior position in the severe HO group for standard implants. CONCLUSIONS: Our results confirm the influence of CORi location on segmental alignment, kinematics and HO for a semi-constrained CTDR, but it also indicates a multifactorial process.

• MeSH
• Total Disc Replacement MeSH
• Adult MeSH
• Ossification, Heterotopic etiology   MeSH
• Cervical Vertebrae diagnostic imaging   surgery   MeSH
• Middle Aged MeSH
• Humans MeSH
• Lordosis diagnostic imaging   MeSH
• Intervertebral Disc diagnostic imaging   surgery   MeSH
• Follow-Up Studies MeSH
• Prospective Studies MeSH
• Radiography MeSH
• Severity of Illness Index MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

• MeSH
• Total Disc Replacement methods   MeSH
• Intervertebral Disc Degeneration surgery   MeSH
• Adult MeSH
• Cervical Vertebrae surgery   MeSH
• Humans MeSH
• Intervertebral Disc surgery   MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Case Reports MeSH