A refined method of en bloc open-door laminoplasty for resection of intradural spinal tumors in the thoracic and lumbar spine.

BACKGROUND: The open-door laminoplasty has been used to treat cervical spondylotic myelopathy. This technique has been applied to the surgical treatment of thoracic and lumbar spinal canal tumors instead of simple laminectomy or hemilaminectomy. However, previously reported laminoplasty methods did not keep posterior supporting elements intact such as the laminae and the spinous processes with supraspinous and interspinous ligaments, and almost all of them needed instruments for the fixation of reconstructed laminae. The purpose of this paper is to introduce our open-door laminoplasty method, which keep all posterior supporting elements intact and reconstruct the laminae without instrument. METHODS: Eight patients (mean age 61 years) underwent en bloc open-door laminoplasty in the thoracic and lumbar spine for resection of intradural spinal tumors. Two grooves are made bilaterally on the laminae just medial side of the facet joints. One-half of each spinous process of the adjacent vertebrae above and below the laminoplasty is cracked diagonally to create a green stick fracture and bent to the hinged side for sufficient elevation of the laminar flap. After tumor resection, the laminar flap is restored to its original site, resulting in the complete preservation of the posterior supporting elements. RESULTS: Operative exposure was good and permitted complete resection. No complications such as postoperative spinal canal stenosis or kyphosis were observed. Computed tomography(CT) indicated that bony fusion occurred in all cases. CONCLUSION: The supraspinous and interspinous ligaments above and below laminoplasty were kept intact during surgery in our method. Therefore, the continuity of posterior supporting elements (laminae and spinous processes connected by supraspinous and interspinous ligaments) were completely preserved.

Randomized trial of granulocyte colony-stimulating factor for spinal cord injury.

Attenuation of the secondary injury of spinal cord injury (SCI) can suppress the spread of spinal cord tissue damage, possibly resulting in spinal cord sparing that can improve functional prognoses. Granulocyte colony-stimulating factor (G-CSF) is a haematological cytokine commonly used to treat neutropenia. Previous reports have shown that G-CSF promotes functional recovery in rodent models of SCI. Based on preclinical results, we conducted early phase clinical trials, showing safety/feasibility and suggestive efficacy. These lines of evidence demonstrate that G-CSF might have therapeutic benefits for acute SCI in humans. To confirm this efficacy and to obtain strong evidence for pharmaceutical approval of G-CSF therapy for SCI, we conducted a phase 3 clinical trial designed as a prospective, randomized, double-blinded and placebo-controlled comparative trial. The current trial included cervical SCI [severity of American Spinal Injury Association (ASIA) Impairment Scale (AIS) B or C] within 48 h after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group was administered 400 µg/m2/day × 5 days of G-CSF in normal saline via intravenous infusion for five consecutive days. The placebo group was similarly administered a placebo. Allocation was concealed between blinded evaluators of efficacy/safety and those for laboratory data, as G-CSF markedly increases white blood cell counts that can reveal patient treatment. Efficacy and safety were evaluated by blinded observer. Our primary end point was changes in ASIA motor scores from baseline to 3 months after drug administration. Each group includes 44 patients (88 total patients). Our protocol was approved by the Pharmaceuticals and Medical Device Agency in Japan and this trial is funded by the Center for Clinical Trials, Japan Medical Association. There was no significant difference in the primary end point between the G-CSF and the placebo control groups. In contrast, one of the secondary end points showed that the ASIA motor score 6 months (P = 0.062) and 1 year (P = 0.073) after drug administration tend to be higher in the G-CSF group compared with the placebo control group. Moreover, in patients aged over 65 years old, motor recovery 6 months after drug administration showed a strong trend towards a better recovery in the G-CSF treated group (P = 0.056) compared with the control group. The present trial failed to show a significant effect of G-CSF in primary end point although the subanalyses of the present trial suggested potential G-CSF benefits for specific population.

Study protocol for the G-SPIRIT trial: a randomised, placebo-controlled, double-blinded phase III trial of granulocyte colony-stimulating factor-mediated neuroprotection for acute spinal cord injury.

INTRODUCTION: Granulocyte colony-stimulating factor (G-CSF) is generally used for neutropaenia. Previous experimental studies revealed that G-CSF promoted neurological recovery after spinal cord injury (SCI). Next, we moved to early phase of clinical trials. In a phase I/IIa trial, no adverse events were observed. Next, we conducted a non-randomised, non-blinded, comparative trial, which suggested the efficacy of G-CSF for promoting neurological recovery. Based on those results, we are now performing a phase III trial. METHODS AND ANALYSIS: The objective of this study is to evaluate the efficacy of G-CSF for acute SCI. The study design is a prospective, multicentre, randomised, double-blinded, placebo-controlled comparative study. The current trial includes cervical SCI (severity of American Spinal Injury Association (ASIA) Impairment Scale B/C) within 48 hours after injury. Patients are randomly assigned to G-CSF and placebo groups. The G-CSF group is administered 400 µg/m2/day×5 days of G-CSF in normal saline via intravenous infusion for 5 consecutive days. The placebo group is similarly administered a placebo. Our primary endpoint is changes in ASIA motor scores from baseline to 3 months. Each group includes 44 patients (88 total patients). ETHICS AND DISSEMINATION: The study will be conducted according to the principles of the World Medical Association Declaration of Helsinki and in accordance with the Japanese Medical Research Involving Human Subjects Act and other guidelines, regulations and Acts. Results of the clinical study will be submitted to the head of the respective clinical study site as a report after conclusion of the clinical study by the sponsor-investigator. Even if the results are not favourable despite conducting the clinical study properly, the data will be published as a paper. TRIAL REGISTRATION NUMBER: UMIN000018752.

Simultaneous anterior and posterior screw fixations confined to the axis for stabilization of a 3-part fracture of the axis (odontoid, dens, and hangman fractures): report of 2 cases.

Fractures of the axis are considered to be one of the most common injuries to the cervical spine, accounting for more than 20% of all cervical spine fractures. Multiple fractures of the axis are much rarer, accounting for 1% of all cervical fractures. Management of such complex fractures is still challenging, and there is no strong consensus for the treatment. The authors describe the cases of 2 patients who presented with 3-part fractures of the axis consisting of an odontoid Type II fracture and a Levine-Edwards Type IA fracture, which were treated with concurrent insertion of an anterior odontoid screw and bilateral posterior pedicle screws. The cases presented were characterized by 1) a Type II odontoid fracture; 2) a Type IA traumatic spondylolisthesis with no or a little translation and angulation of C-2 on C-3 in a ring fracture of the axis; and 3) no disorders at the C2-3 disc on MR images. Therefore, the authors performed surgery confined to the axis by concurrently inserting an anterior odontoid screw and posterior bilateral pedicle screws without arthrodesis of C2-3. This was followed with cervical soft collar fixation for only 1-2 weeks. The outcomes were favorable, including good osteosynthesis, high primary stability, early patient mobilization, and preserved range of motion of the cervical spine at C2-3 as well as at C1-2.