We performed CT myelography in 38 patients with cervical myelopathy before and after laminoplasty to enlarge the canal. The sagittal and transverse diameters, the cross-sectional area, and the central point of the spinal cord were measured. After cervical laminoplasty, the mean sagittal diameter of the spinal cord at C5 increased by 0.8 mm, but the mean transverse diameter decreased by 0.9 mm. The mean cross-sectional area of the cord increased by 7.4% and that of the dural sac and its contents by 33.8% at C5. The centre of the spinal cord moved a mean 2.8 mm posteriorly at this level. Enlargement of the spinal canal is sufficient to decompress the spinal cord, but posterior movement may be the limiting factor in determining the decompressive effect of laminoplasty.

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.

We performed CT myelography in 38 patients with cervical myelopathy before and after laminoplasty to enlarge the canal. The sagittal and transverse diameters, the cross-sectional area, and the central point of the spinal cord were measured.After cervical laminoplasty, the mean sagittal diameter of the spinal cord at C5 increased by 0.8 mm, but the mean transverse diameter decreased by 0.9 mm. The mean cross-sectional area of the cord increased by 7.4% and that of the dural sac and its contents by 33.8% at C5. The centre of the spinal cord moved a mean 2.8 mm posteriorly at this level.Enlargement of the spinal canal is sufficient to decompress the spinal cord, but posterior movement may be the limiting factor in determining the decompressive effect of laminoplasty. [Br] 1998;80-B:33-7. Received 28 April 1997; Accepted after revision 8 July 1997 In patients with cervical myelopathy, anterior interbody fusion or laminoplasty is performed to expand the canal. In some cases, both anterior and posterior operations are done at the same time. We usually undertake laminoplasty for patients who have developmental spinal stenosis. There are many variations of the technique 1-7 and good clinical results have been reported for all of them. Our method is the 'open-door' type which uses the spinous processes as bone blocks, thereby requiring no additional theatre time for taking grafts from the iliac crest and avoiding the complications of iliac-crest bone donor sites. Moreover, central laminar osteotomies to enlarge the spinal canal are very safe since the spinous processes have been previously resected. J Bone Joint SurgAfter laminoplasty, the spinal cord is decompressed and also moves posteriorly (Fig. 1) Patients and MethodsWe performed laminoplasty in 38 patients, 26 men and 12 women. Their mean age was 56 years (29 to 85) at the time of the operation. Nineteen patients had cervical myelopathy and 17 had ossification of the posterior longitudinal ligament. The remaining two had hypertrophy of the posterior longitudinal ligament and calcification of the ligamentum flavum.The laminoplasty was performed from C3 to C7 in 36 patients, from C3 to T2 in one, and from C2 to T2 in one. Operative technique (Fig. 2). The patient is placed prone and a straight midline skin incision is used. The paravertebral muscles are resected from the spinous processes and the posterior surfaces of the laminae are exposed. The insertion of the semispinalis muscle to C2 is preserved.The spinous processes are resected so that their bases are longer than 5 mm, and their remnants are split with a highspeed drill. At the transitional portion of the laminae and facet joints, the laminae are thinned enough to allow them to be pushed laterally, the 'open-door' technique. The widths of the lateral gutters are determined by CT myelography (CTM) before the operation.The laminae are opened and any adhesions to the dura mater are dissected off. Bone blocks approximately 10 to 15 mm long from the spinous processes are then inserted at the site of the lamin...

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IntroductionGranulocyte 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 analysisThe 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 disseminationThe 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 numberUMIN000018752.