骨小梁型髋关节假体应用于初次全髋关节置换术的短期安全性与效果评价

Short-term evaluation of safety and effect of bone trabecular prosthesis in primary total hip arthroplasty

背景:仿生人工骨小梁与生物骨的结构高度相似,对生物骨具有一定的骨诱导作用。目的:验证骨小梁型髋关节假体应用于初次全髋关节置换术(THA)的短期安全性和疗效。方法:前瞻性选取2014年8月至2016年2月收治的60例初次单侧THA患者,随机分为受试组(骨小梁假体)和对照组(S-ROM假体)各30例。两组患者性别、年龄、体质指数、疾病类型、麻醉分级、术前患侧髋关节Harris评分等一般资料均无统计学差异(P>0.05)。观察两组患者手术切口长度、手术持续时间、失血量、术后下地时间、输血率、术后住院时间和并发症,比较两组患者术后髋关节Harris评分、疼痛视觉模拟评分(VAS)、假体生存率及患者满意度,并通过X线片、CT评估假体稳定性及骨长入情况,通过B超评估假体周围软组织反应情况。结果:两组患者均获得随访,受试组1例出现股骨转子下短缩截骨,其余均双下肢等长。对照组随访1.5～3.0年,平均(2.2±0.6)年;受试组随访1.8～2.8年,平均(2.4±0.4)年。两组患者手术切口长度、手术时间、失血量、术后下地时间、术后住院时间及输血率比较均无统计学差异(P>0.05),髋关节Harris评分较术前明显改善(P<0.05),但组间比较无统计学差异(P>0.05),受试组术后3 d、1周及2周VAS评分高于对照组(P<0.05),其余时段比较均无统计学差异(P>0.05)。末次随访两组患者假体固定牢固,无手术相关并发症及不良事件发生,髋关节Harris评分均为优良。两组患者满意度分别为96.3%和94.8%。结论:骨小梁型髋关节假体构造与S-ROM假体类似,植入后稳定性和骨长入良好,短期随访安全有效。

Background:Bionic bone trabecula is similar to the structure of natural bone and has a certain bone induced effect on natural bone.Objective:To evaluate the short-term safety and clinical effect of bone trabecular prosthesis in primary total hip arthroplasty(THA).Methods:A total of 60 patients undergoing primary THA from August 2014 to February 2016 were selected and randomly divided into experimental group using bone trabecular prosthesis and control group using S-ROM prosthe-sis,with 30 cases in each group.There was no significant difference in gender,age,body mass index(BMI),disease types,Amer ican Society of Anesthesiology(ASA)classification and preoperative Harris score between the two groups(P>0.05).The operative incision length,surgery duration,blood loss,postoperative ambulation time,blood transfusion rate,postoperative hospitalization time and the incidence of complications in two groups were evaluated.The hip Harris score,visual analogy score(VAS),prosthesis survival rate and patient satisfaction were compared between the two groups.The stability of the prosthesis and the bone ingrowth were evaluated by X-ray or CT,and the soft tissue reaction around the prosthesis was evaluated by Doppler ultrasound.Results:All patients completed follow-up.One patient had subtrochanteric shortening osteotomy in experimental group,the rest had equal leg length after total hip arthroplasty.Patients in the control group were followed up for 1.5-3.0 years,with an average of(2.2±0.6)years;and patients in the experimental group were followed up for 1.8-2.8 years,with an average of(2.4±0.4)years.There were no significant differences in the length of incision,operation time,blood loss,postoperative ambulation time,postoperative hospital stay and blood transfusion rate between the two groups(P>0.05).The Harris hip scores of the two groups were both significantly improved compared with those before operation(P<0.05),but no statistical significance between the two groups(P>0.05).The VAS score of experimental group was statistically higher than that of control group at the time of 3 days,1 week and 2 weeks after operation(P<0.05),but no statistical significance at other time points(P>0.05).At the last follow-up,the prostheses of the patients in the two groups were stable,no surgical complications and adverse events occurred,and the Harris score of the hip joint was excellent and good.The satisfaction was 96.3%and 94.8%respectinely in the experimental group and the control group.Conclusions:The structure of trabecular bone prosthesis is similar to the S-ROM prosthesis,thestability and bone ingrowth are satisfactory,and the safety and efficacy are good judgedfrom the short-term follow-up.