新型可降解镁骨内固定螺钉在股骨头坏死治疗中的应用研究

Clinical study of a new biodegradable magnesium internal fixation screw in treatment of osteonecrosis of the femoral head

目的 探讨新型可降解镁骨内固定螺钉用于股骨头坏死(osteonecrosis of the femoral head,ONFH)带血管蒂髂骨瓣移植术的安全性及有效性。方法 以2020年7月—2021年2月收治的ONFH患者作为研究对象,其中20例(20髋)符合选择标准纳入研究,采用中央随机方法将患者分为两组(n=10)。带血管蒂髂骨瓣移植术中,试验组采用新型可降解镁骨内固定螺钉固定髂骨瓣,对照组采用髂骨瓣直接楔入。两组患者性别、年龄以及ONFH侧别、类型、国际骨循环研究协会(ARCO)分期、病程等一般资料比较,差异均无统计学意义(P>0.05)。记录两组手术时间以及术中出血量;手术前后行实验室检查,包括白细胞计数(white blood cell,WBC)、电解质(K、Ca、P、Mg)、尿素氮(blood urea nitrogen,BUN)、血肌酐(serum creatinine,Scr)、肾小球滤过率(glomerular filtration rate,eGFR)、淋巴细胞比例(CD4/CD8)、免疫球蛋白G(immunoglobulin G,IgG)、IgM、谷丙转氨酶(alanine transaminase,ALT)、谷草转氨酶(aspartate aminotransferase,AST);术后采用Harris评分评价髋关节功能,髋关节CT和骨盆正位及蛙式位X线片复查髂骨瓣位置、融合以及试验组螺钉降解情况。结果 术后两组患者生命体征均平稳,切口均Ⅰ期愈合,无不良事件发生。对照组1例术后3个月拒绝回院随访1次、试验组1例术后1年拒绝回院随访1次,其余患者均完成术后2周,3、6个月及1年随访。实验室检查示手术前后各时间点两组WBC、电解质(K、Ca、P、Mg)、BUN、Scr、eGFR、CD4/CD8、IgG、IgM、ALT、AST比较,差异均无统计学意义(P>0.05)。试验组手术时间及术中出血量均低于对照组(P<0.05)。两组术后1年Harris评分高于术前及术后6个月,差异均有统计学意义(P<0.05);各时间点两组间比较,差异均无统计学意义(P>0.05)。影像学复查示两组术后1年时髂骨瓣均与股骨头颈交界区开窗处达骨性融合,随访期间未见髂骨瓣松动、脱落;试验组可见新型可降解镁骨内固定螺钉溶解吸收征象,螺钉直径逐渐减小(P<0.05),随访期间未见螺钉断裂及脱落。结论 带血管蒂髂骨瓣移植术治疗ONFH时,术中采用新型可降解镁骨内固定螺钉固定髂骨瓣牢固,与传统髂骨瓣直接楔入相比能获得相似关节功能,且手术时间短、术中出血少。

Objective To investigate the safety and efficacy of a new biodegradable magnesium internal fixation screw for vascularized iliac bone flap grafting in treatment of osteonecrosis of the femoral head(ONFH).Methods Patients with ONFH admitted between July 2020 and February 2021 were selected as the research objects,and20 patients(20 hips) met the selection criteria and were included in the study.The patients were divided into two groups(n=10) by central random method.The iliac bone flap was fixed with a new biodegradable magnesium internal fixation screw in the trial group,and the iliac bone flap was wedged directly in the control group.There was no significant difference(P>0.05) in gender,age,and side,type,Association Research Circulation Osseous(ARCO) stage,and disease duration of ONFH between the two groups.The operation time and intraoperative blood loss of the two groups were recorded.Laboratory tests were performed at each time point before and after operation,including white blood cell(WBC),electrolytes(K,Ca,P,Mg),blood urea nitrogen(BUN),serum creatinine(Scr),glomerular filtration rate(eGFR),lymphocyte ratio(CD4/CD8),immunoglobulin G(IgG),IgM,alanine transaminase(ALT),aspartate aminotransferase(AST).After operation,Harris score was used to evaluate the hip joint function.CT of the hip joint and X-ray films in anteroposterior and frog positions of the pelvis were used to review the iliac bone flap position,fusion,and screw biodegradation in the trial group.Results The vital signs of the two groups were stable,the incisions healed by first intention,and no adverse events occurred after operation.One patient in the control group refused to return to the hospital for follow-up at 3 months after operation,and 1 patient in the trial group refused to return to the hospital for follow-up at 1 year after operation.The rest of the patients completed the follow-up at 2 weeks,3 months,6 months,and 1 year after operation.Laboratory tests showed that there was no significant difference in WBC,electrolytes(K,Ca,P,Mg),BUN,Scr,eGFR,CD4/CD8,IgG,IgM,ALT,and AST between the two groups at each time point before and after operation(P>0.05).The operation time and intraoperative blood loss of the trial group were significantly less than those of the control group(P<0.05).The Harris scores of the two groups at 1 year significantly increased when compared with the values before operation and at 6 months after operation(P<0.05).There was no significant difference in Harris score between the two groups at each time point(P>0.05).Postoperative CT of hip joint and X-ray films of pelvis showed that the iliac bone flap reached osseous fusion with the fenestration of the head and neck junction of femoral head in the two groups at 1 year after operation,and no loosening or shedding of iliac bone flap was observed during follow-up.In the trial group,there were signs of dissolution and absorption of the new biodegradable magnesium internal fixation screws after operation,and the diameter of the screws gradually decreased(P<0.05);no screw breakage or detachment occurred during follow-up.Conclusion In the treatment of ONFH with vascularized iliac bone flap grafting,the new biodegradable magnesium internal fixation screws can fix the iliac bone flap firmly.Compared with the traditional iliac bone flap wedging directly,it has a shorter operation time,less intraoperative blood loss,and can obtain similar joint function.