Follow-up of a new titanium cervical plate for fusion of the cervical spine.

Cervical plates are in use since the 1990ies for anterior cervical discectomy and fusion (ACDF). The latest step in development was a dynamic plate that allows sliding of the screws facilitating the natural settling of the bone after surgery. We investigated the clinical and radiological results of such a dynamic plate in a patient cohort that underwent single or multi-level ACDF for various cervical degenerative indications, including revision cases, from 2014 to 2019. Clinical and radiological outcome were assessed in 60 eligible patients after a mean of 2.9 years. The assessed neck disability index (NDI), and the visual analogue scale (VAS) of neck and arm pain show comparable results to the literature of ACDF, and specifically other plate designs. Forty-eight Adverse and Serious Adverse Events do not show a link to the product used. Clinical and radiological outcomes of ACDF with dynamic, third generation cervical plates show comparable results to the literature. Careful reporting of all Adverse Events revealed a variety of concomitant diseases, but could not be correlated to the implant used.

Four-year results of a prospective single-arm study on 200 semi-constrained total cervical disc prostheses: clinical and radiographic outcome.

OBJECTIVE Recent studies have described encouraging outcomes after cervical total disc replacement (cTDR), but there are also critical debates regarding the long-term effects of heterotopic ossification (HO) and the prevalence of adjacent-level degeneration. The aim in this paper was to provide 4-year clinical and radiographic outcome results on the activ C disc prosthesis. METHODS A total of 200 subjects underwent single-level activ C (Aesculap AG) implantation between C-3 and C-7 for the treatment of symptomatic degenerative disc disease. Clinical and radiographic assessments were performed preoperatively, intraoperatively, at discharge, and again at 6 weeks, 6 months, 1 year, 2 years, and 4 years. Radiographic evaluations were done by an independent core laboratory using a specific software for quantitative motion analysis. RESULTS Neck Disability Index (NDI) and visual analog scale (VAS) score for neck and arm pain decreased significantly from baseline to the 4-year follow-up. The mean improvement for NDI was 20, for VAS severity and frequency of neck pain 26.4 and 28, and for VAS severity and frequency of arm pain 30.7 and 35.1, respectively. The neurological situation improved for the majority of patients (86.4%); 76.1% of cases were asymptomatic. Subsequent surgical interventions were reported in 7% of the cases, including device removals in 3%. In 2.5% a subsidence greater than 3 mm was recorded; 1 of these cases also had a migration greater than 3 mm. No device displacement, expulsion, disassembly, loose or fractured device, osteolysis, or facet joint degeneration at the index level was observed. Segmental lordotic alignment changed from -2.4° preoperatively to -6.2° at 4 years, and postoperative height was maintained during the follow-up. Advanced HO (Grade III and IV) was present in 27.1% of the cases; 82.4% showed segmental mobility. A progression of radiographic adjacent-segment degeneration occurred in 28.2%, but only 4.5% required surgical treatment. CONCLUSIONS The activ C is a safe and effective device for cervical disc replacement confirming the encouraging results after cTDR. Clinical trial registration no.: NCT02492724 ( clinicaltrials.gov ).

Effectiveness of cemented rescue screws for anterior cervical plate fixation.

OBJECT: Among the various ways to optimize the fixation of bone implants is to use bone cement, for example, in a total hip prosthesis. No data exist, however, concerning the effectiveness of cemented rescue screws for anterior cervical plate fixation. The aim of this study was to investigate whether cemented rescue screws increase fixation strength in comparison with uncemented standard screws. METHODS: Six cervical spine segments (C4-7) were explanted during routine autopsy studies from fresh human cadavers. Bone mineral density (BMD) was measured for each vertebral body (VB) using quantitative computerized tomography scanning, and 24 VBs were dissected from the segments. Two initial pilot holes were drilled into each VB parallel to the sagittal plane. Based on their BMD, the specimens were assigned to one of two groups in which torque and pullout force were tested. The test was begun with standard screws and was repeated with cannulated slotted rescue screws into which bone cement was injected. The mean values of peak torque and pullout forces resulting from the left and right measurements were used for statistical analysis. A t-test was performed to determine the effect of screw type on peak torque and pullout force. Moment correlation coefficients were calculated to determine the effect of BMD on peak torque and pullout force for each type of screw. The mean insertional peak torque was 67.1 N/cm for the standard screw and 102.6 N/cm for the cemented screw (p < 0.05). The mean pullout force was 526.9 N for standard osteoporosis screws and 531.5 N for cemented screws (p > 0.05). The effect of increased holding strength as measured by peak torque and pullout force was more pronounced in the presence of low bone density. CONCLUSIONS: Cemented rescue screws that have been inserted into a fatigued pilot hole in the cervical VB strengthen the screw-bone interface compared with the strength initially conferred by a standard screw.