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Regenos spacers are not suitable for open-door laminoplasty because of serious adverse events caused by their insufficient mechanical strength

Hiroshi Noguchi, Masao Koda, Toru Funayama, Hiroshi Kumagai, Junya Saito, Chikato Mannoji, Masaaki Aramomi, Tetsuya Abe, Katsuya Nagashima, Kousei Miura, Kentaro Mataki, Kengo Fuji, Takeo Furuya, Masashi Yamazaki
Journal of Clinical Neuroscience: Official Journal of the Neurosurgical Society of Australasia 2018 July 17
We used a newly developed, high-porosity unidirectional porous hydroxyapatite spacer (Regenos spacer, not approved by the FDA). The aim of the present study was to elucidate the effectiveness of Regenos laminar spacers for open-door type laminoplasty. The present study included 39 patients who underwent open-door type laminoplasty with Regenos spacers from April 2015 to December 2016 and were followed up for at least 6 months after surgery. We grafted 68 Regenos spacers in 39 patients. Pre- and postoperative neurological status of patients were evaluated using JOA score and recovery rate. Breakage of Regenos spacers, laminar closure, and bone-hydroxyapatite spacer bonding were assessed using 12-month postoperative sagittal and axial CT images. The average preoperative JOA score was 9.5 ± 3.2/17, and the average postoperative JOA score was 12.5 ± 2.9/17. JOA score recovery rate was 34 ± 41% at the latest follow-up visit. The bony fusion rate of the hinge sides was 87%. Breakage and deformity of implanted spacers was observed in 69% of patients and 59% of spacers with a CT sagittal view, and CT axial view at 12 months revealed fine cracks and collapse in 17 spacers in 14 patients. The average angle was -2.4 ± 4.8°, including 46 of 68 spacers showing a negative value, resulting in a rate of laminar reclosure of 35%. Postoperative CT demonstrated good bone bonding rate. Nevertheless, clinical results with low recovery rates were obtained with complications related to the use of Regenos spacers.

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