BACKGROUND:In senile osteoporosis patients, capacity of pedicle screw fixation is relatively poor due to fragile bone substance. Currently, augmentation of pedicle screw fixation with bone cement can improve the ability of screw fixation, but bone cement leakage and difficulties in screw removal become the problem to be solved. OBJECTIVE:To develop a novel pourable pedicle bone cement and to investigate its biomechanical properties, safety and practicality, thus providing the basis for clinical treatment of osteoporosis and spinal diseases.
METHODS:Six cases of complete wetting spines were colected at the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine from December 2013 to January 2015, including 42 vertebrae. Pedicle screw fixation with X-ray assisted bone cement injection (2 mL) was performed unilateraly as experimental group, and conventional pedicle screw fixation was done contralateraly as control group. Bone cement dispersion was observed in the two groups. RESULTS AND CONCLUSION:It was 3-4 minutes for bone cement to agglomerate. Injection of bone cement paste into the infusion cylinder using a syringe was more convenient. The cylinder was connected tightly with the tail-end of the screw with no leakage. The push bar could provide sufficient perfusion force. Bone cement dispersion was found in the holow part and side holes of the screw. Side holes arranged regularly, and the hole pitch was equal. Compared with the control group, the yield load and yield displacement were significantly higher in the experimental group (P < 0.05), but the ultimate strength and ultimate displacement were significantly lower in the experimental group (P < 0.05). Bone cement around the pourable cement screw dispersed regularly, which was diffused into the surround cancelous bone and integrated with adjacent bone cement mass. The axial withdrawal force was increased by 114% in the experimental group compared with the control group (P < 0.05). The maximum rotary torque was significantly higher in the experimental group than the control group (P< 0.05). These finding suggest that the new pourable cement screw combined with bone cement putter and infusion cylinder is applied more convenient, can effectively control the leakage of bone cement, and can improve the stability of the pedicle in osteoporosis patients, which has been widely used.

Objective To investigate the effect of hydrogen peroxide (H_2O_2) on apoptosis and calcium ion concentration of skeletal muscle satellite cells (SMSCs) in rats, and to explore the protective effect of erythropoietin (EPO).Methods The cultured SMSCs were divided into five groups: control group,H_2O_2 group, 10, 20 and 40 U/ml EPO intervention groups.Apoptosis rates and calcium ion concentration of SMSCs were analyzed by flow cytometry, and the morphology of apoptotic cells was observed by Hoechst33258 staining.Results The apoptosis rates showed significant differences (all P<0.05) among (1.93±0.57)% in control group, (22.13±1.79)% in H_2O_2 group, (16.47±2.53)%, (4.97±0.55)% and (2.93±0.47)% in 10, 20 and 40 U/ml EPO intervention groups, respectively.And calcium ion concentrations in SMSCs were 12.67 ±0.32, 27.90±0.06 and 44.53±0.93 in 10, 20 and 40 U/ml EPO intervention groups, respectively.There was significant difference in calcium ion concentration between H_2O_2 group and control group (9.70±0.09 vs.51.37± 0.64, P< 0.05).Morphology of apoptosis was observed by Hoeehst33258 dye stains in 10, 20 U/ml EPO intervention group and H_2O_2 group, while there were less apoptotic bodies in 40 U/ml EPO intervention group and control group.Conclusions EPO might have protective effects on SMSCs injured by H_2O_2 through inhibiting apoptosis and calcium ion releasing from SMSCs.

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.