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Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease
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Mid- to long-term outcome of instrumented anterior cervical fusion for subaxial injuries
The management of patients with subaxial cervical injuries lacks consensus, particularly in regard to the decision which surgical approach or combination of approaches to use and which approach yields the best clinical outcome in the distinct injury. The trauma literature is replete with reports of surgical techniques, complications and gross outcome assessment in heterogeneous samples. However, data on functional and clinical outcome using validated outcome measures are scanty. Therefore, the authors performed a study on plated anterior cervical decompression and fusion for unstable subaxial injuries with focus on clinical outcome. For the purpose of a strongly homogenous subgroup of patients with subaxial injuries without spinal cord injuries, robust criteria were applied that were fulfilled by 28 patients out of an original series of 131 subaxial injuries. Twenty-six patients subjected to 1- and 2-level fusions without having spinal cord injury could be surveyed after a mean of 5.5 years (range 16–128 months). The cervical spine injury severity score averaged 9.6. Cross-sectional outcome assessment included validated outcome measures (Neck pain disability index, Cervical Spine Outcome Questionnaire, SF-36), the investigation of construct failure and successful surgical outcome were defined by strict criteria, the reconstruction and maintenance of local and total cervical lordosis, adjacent-segment degeneration and intervertebral motion, and the fusion-rate using an interobserver assessment. Self-rated clinical outcome was excellent or good in 81% of patients and moderate or poor in 19% that corresponded to the results of the validated outcome measures. Results of the NPDI averaged 12.4 ± 12.7% (0–40). With the SF-36 mean physical and mental component summary scores were 47.0 ± 9.8 (18.2–59.3) and 52.2 ± 12.4 (14.6–75.3), respectively. Using merely non-constrained plates, construct failure was observed in 31% of cases and loss of local lordosis, expressed as a mean injury angle of 14°, postoperative angle of −5.5° and follow-up angle of −1°, was significant. However, total cervical lordosis was within the limits of normalcy (−24.3° ± 13.3) and fusion-rate was 88.5%. The progression of adjacent-level degeneration was shown to be significantly influenced by a decreased plate-to-disc-distance. Adjacent-level intervertebral motion was not altered due to the adjacent fusion, but reduced in the presence of advanced adjacent-level degeneration. Patients were more likely to maintain a high satisfaction level if they succeeded to maintain segmental lordosis (<0°), had a solid fusion, an increased plate-to-disc distance, and if they were judged to have a successful surgical outcome that included the absence of construct failure and reconstruction of lordosis within ±1 SD of normalcy. Using validated outcome vehicles the interdependencies between radiographical, functional and clinical outcome parameters could be substantiated with statistically significant correlations. The use of validated outcome vehicles in a subgroup of patients with plated anterior cervical fusions for subaxial injuries is recommended. With future studies, it enables objective comparison of surgical techniques and related radiographical, functional and clinical outcome