| Objective:To compare the clinical efficacy of the metal tie wire and the Ximai shape memory alloy sternum fixator,the safety and effectiveness of the Ximai shape memory alloy sternum fixator after a median sternotomy were evaluated.Methods:Selected heart disease patients who were admitted to the Department of Cardiac Surgery of Lanzhou University First Hospital from May 2019 to December 2019 and required median sternotomy for treatment.According to the inclusion and exclusion criteria of prospective clinical studies,the patients were randomly divided into two groups.The control group used metal ties for median sternotomy and internal fixation,and the experimental group used Ximai memory alloy sternotomy fixation for median sternotomy and internal fixation.By comparing the two groups of patients before discharge,3 months after surgery,and 6 months after surgery,the degree of sternal healing,implant stability,intraoperative sternal closure time,intensive care unit（Intensive Care Unit,ICU）hospitalization days,postoperative Indices such as hospitalization days and visual analogue scale（VAS）score to evaluate the effectiveness of the Ximai memory alloy sternum fixator.The safety of the Ximai memory alloy sternum fixator was evaluated by comparing the occurrence of local reactions,complications and adverse events before discharge,3 months after operation,and 6 months after operation between the two groups.Results:According to the inclusion and exclusion criteria,57 surgical patients were finally included,including 29 in the control group and 28 in the experimental group.Fully prepared before surgery,all successfully performed median sternotomy heart surgery.Preoperative baseline data of the two groups of patients,such as gender,age,and body mass index（BMI）smoking type,history of hypertension,history of coronary heart disease,history of diabetes,history of insulin use,renal insufficiency,cardiac insufficiency,chronic There was no significant difference in lung history,atrial fibrillation,sinus bradycardia,and type of surgery（P>0.05）.In terms of fracture healing,the test group was significantly better than the control group at 3 months after operation（P=0.03）,and there was no statistical significance between the two groups before discharge and 6 months after operation（P>0.05）;In terms of the stability of entry,the comparison between the two groups before discharge,3 months after operation and 6 months after operation was not statistically significant（P>0.05）.In the intraoperative sternal closure time,the experimental group was significantly shorter than the control group（13.70±2.70 min VS 16.60±1.80 min,P=0.00）,and there were no records of device defects,adverse reactions and serious adverse reactions in the two groups during the operation.There was no significant difference between the two groups in terms of postoperative hospital stay and ICU hospital stay（P>0.05）.In terms of VAS score,3 months after operation（2.51±0.49 VS2.86±0.42,P=0.01）and 6 months after operation（1.30±0.43 VS 1±0.44,P=0.01）,the experimental group was significantly smaller than the control group.However,there was no statistical significance in intermittent pain,daily chest wall pain,continuous pain,and whether to take analgesics（P>0.05）.In terms of local reactions,complications and adverse events,the comparison between the two groups before discharge,3 months after surgery and 6 months after surgery was not statistically significant（P>0.05）.All patients reached the clinical standard of sternal healing 6 months after operation.Conclusion:Compared with the clinical effects of traditional metal wire ties,the Ximai memory alloy sternum fixator can significantly shorten the sternal closure time and reduce sternal pain to a certain extent,without increasing local reactions,complications and adverse reactions,so it is in clinical practice The above application is safe and feasible. |
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