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

Abstract

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.

Keywords: Bone bonding; Cervical spine; Complication; Hydroxyapatite; Laminar reclosure; Open-door laminoplasty; Spacer.