【作者】 张龙；

【导师】 屈云；

【作者基本信息】 四川大学 ， 医学技术（康复治疗学）， 2023， 硕士

【摘要】 目的:基于既往发育性髋关节发育不良(developmental dysplasia of the hip,DDH)术后早期康复干预研究的缺乏,通过随机对照试验来观察术后早期及不同时机的康复干预对DDH患儿结构、功能、活动及参与的影响,以筛选DDH术后康复干预的适宜时机,为制定标准化、规范化的DDH术后临床康复路径提供有力的证据支持。资料和方法:选取2020年5月至2022年2月于四川大学华西医院就诊并符合本研究纳入标准的DDH患儿40例,所有患儿均实施髋关节切开复位、骨盆截骨以及伴或不伴有股骨短缩旋转截骨术。按照PASS软件计算出的随机序列分为试验组与对照组,每组20例。试验组和对照组分别于术后10天和6周开始进行康复干预,康复干预内容包括坐位训练(持续5周)、下肢活动(持续5周)、站立及步行训练(持续1～2周),总时间持续3个月左右。开始康复干预后3月、12月对两组患儿临床结局进行评定,评估内容包括髋臼指数(acetabular index,AI)、Severin影像学评价标准、髋关节屈曲活动度、Mckay髋关节功能评价标准、日常生活活动能力(Activity of daily living,ADL)以及Peds QL 4.0生活质量量表,并对髋关节再脱位、股骨头坏死(Avascular necrosis of the femoral head,AVN)等并发症进行记录、分析,同时对与康复干预相关的不良事件进行监测。评定结果通过SPSS 23.0软件进行统计分析,并采用Graph Pad Prism9.0软件进行统计绘图。结果:1.两组患儿年龄、性别、侧别、术前髋关节脱位程度、手术方式、骨盆截骨术式、术前AI及术前AVN差异均无统计学意义(P>0.05),基线资料具有可比性。2.AI:两组AI值随着时间的增加整体均呈下降趋势,差异具有统计学意义(P<0.01)。试验组和对照组组间效应值差异无统计学意义(P>0.05)。3.Severin髋关节影像学评定:两组康复干预后12月相比干预后3月,Severin髋关节影像学优良率均有下降,但试验组下降幅度小于对照组。试验组干预后3月和12月的髋关节影像学优良率均高于对照组,但差异无统计学意义(P>0.05)。4.髋关节屈曲活动度评定:两组康复干预后12月相比干预后3月,髋关节屈曲活动度均有改善(P<0.01)。干预后3月,试验组髋关节屈曲活动度大于对照组,差异具有统计学意义(P<0.05)。干预后12月,试验组髋关节屈曲活动度仍大于对照组,但差异不具有统计学意义(P>0.05)。5.Mckay髋关节功能评定:两组康复干预后12月相比干预后3月,Mckay髋关节功能优良率均有提高,但试验组提高幅度大于对照组。干预后3月及12月,试验组髋关节功能优良率均高于对照组,但差异不具有统计学意义(P>0.05)。6.ADL评定:两组康复干预后12月相比干预后3月,ADL评分均有提高(P<0.05)。干预后3月及12月,试验组ADL评分均高于对照组,差异具有统计学意义(P<0.05)。7.Peds QL 4.0生活质量评定:两组康复干预后12月相比干预后3月,生活质量及各维度(生理功能、情感功能、社交功能、学校表现)总分平均分均有提高,差异具有统计学意义(P<0.01)。试验组干预后3月和12月的生活质量总分平均分均高于对照组,但差异无统计学意义(P>0.05)。8.并发症:试验组有2例患儿于术后10天开始康复干预时发现臀背部有红色的皮疹,经使用炉甘石3～5天后好转。对照组有2例患儿术后2周出现伤口感染(1例伴有压疮,1例伴有钢针部分移出),后经反复换药后好转。康复干预后12月,试验组有1例患儿发生AVN并伴有髋关节疼痛,对照组有1例患儿发生髋关节半脱位。9.不良事件(安全性评估):早期开展DDH术后康复未发生与康复干预直接相关的不良事件;两组患儿康复干预后3月均未发生与康复干预直接相关的不良事件,如髋关节再脱位、伤口破裂、钢针移出、截骨部位移位、钢板断裂等。结论:本研究基于小儿外科-康复科交叉学科的优势,前期通过预试验以多模态评估确定了DDH术后早期开始康复干预的时间,并采用随机对照试验设计,从结构、功能、活动及参与等多个维度进行了随访评估,并证实了DDH术后早期(10天)开始康复干预是安全而有效的,且相比传统的术后6周开始康复干预可改善患儿髋关节屈曲活动受限、提高ADL能力。虽然在髋关节发育和生活质量方面未表现出显著优势,但数据显示早期康复干预后髋关节发育可能会更好、生活质量会更高。更多还原

【Abstract】 Objective:Based on the paucity of previous studies on early rehabilitation intervention after developmental dysplasia of the hip(DDH)surgery.A randomized controlled trial was conducted to observe the effects of rehabilitation intervention at the early stage and different times after DDH surgery on the structure,function,activity and participation of children with DDH,so as to screen the appropriate timing of rehabilitation intervention after DDH surgery and provide strong evidence support for the development of standardized and normalized DDH postoperative clinical rehabilitation pathway.Materials and Methods:Forty children with DDH who were admitted to West China Hospital of Sichuan University from May 2020 to February 2022 and met the inclusion criteria of this study were selected.All children underwent open reduction of the hip joint,pelvic osteotomy and rotational osteotomy with or without femoral shortening.According to the random sequence calculated by PASS software,they were divided into an experimental group and a control group,with 20 cases in each group.The experimental group and the control group began rehabilitation interventions 10 days and 6 weeks after surgery,respectively.The rehabilitation intervention included sitting training(lasting 5 weeks),lower limb mobilization(lasting 5 weeks),standing and walking training(lasting 1-2 weeks),and the total time lasted about 3 months.The clinical outcomes of the two groups were evaluated at 3 months and 12 months after starting the rehabilitation intervention,including Acetabular Index(AI),Severin imaging evaluation standard,hip range of motion of flexion,Mckay hip function evaluation standard,Activities of daily living(ADL),and Peds QL 4.0 quality of life scale.Complications such as hip redislocation and avascular necrosis of the femoral head(AVN)were recorded and analyzed,and adverse events related to rehabilitation intervention were monitored.The evaluation results were statistically analyzed by SPSS 23.0 software,and Graph Pad Prism9.0 software was used for statistical drawing.Results:1.There was no significant difference in age,gender,side,preoperative hip dislocation,surgical method,pelvic osteotomy operation,preoperative AI and preoperative AVN between the two groups(P>0.05).2.AI: The AI values of the two groups showed a downward trend with the increase of time,and the difference was statistically significant(P<0.01).There was no significant difference in the effect value between the experimental group and the control group(P>0.05).3.Severin hip imaging evaluation: The excellent and good rate of Severin hip imaging decreased in both groups at 12 months after intervention compared with 3 months after intervention,but the decrease in the experimental group was smaller than that in the control group.The excellent and good rate of hip joint imaging in the experimental group was higher than that in the control group at 3 and 12 months after intervention,but the difference was not statistically significant(P>0.05).4.Hip range of motion of flexion evaluation: The hip flexion of the two groups was improved at 12 months after intervention compared with 3 months after intervention(P<0.01).At 3 months after intervention,the hip flexion of the experimental group was greater than that in the control group,and the difference was statistically significant(P<0.05).At 12 months after intervention,the hip flexion of the experimental group was still greater than that in the control group,but the difference was not statistically significant(P>0.05).5.Mckay hip function evaluation: The excellent and good rate of Mckay hip function was improved in both groups at 12 months after intervention compared with3 months after intervention,but the improvement rate of the experimental group was greater than that in the control group.At 3 months and 12 months after intervention,the excellent and good rate of hip joint function in the experimental group was higher than that in the control group,but the difference was not statistically significant(P>0.05).6.ADL: The ADL scores of the two groups were improved at 12 months after intervention compared with 3 months after intervention(P<0.05).At 3 months and 12 months after intervention,the ADL scores in the experimental group were higher than those in the control group,and the difference was statistically significant(P<0.05).7.Peds QL 4.0 quality of life: The average scores of quality of life and total scores of each dimension(physiological function,emotional function,social function,school performance)in the two groups were improved at 12 months after intervention compared with 3 months after intervention,and the difference was statistically significant(P<0.01).The average scores of quality of life in the experimental group were higher than those in the control group at 3 months and 12 months after intervention,but the difference was not statistically significant(P>0.05).8.Complication: Two children in the experimental group were found to have red rashes on the buttocks and backs when they began rehabilitation intervention 10 days after surgery,and improved after 3-5 days of using calamine.In the control group,2cases had wound infection 2 weeks after operation(1 case with pressure sore and 1case with partial removal of steel needle),which were improved after repeated dressing changes.At 12 months after intervention,1 patient in the experimental group had AVN and hip pain,and 1 patient in the control group had hip subluxation.9.Adverse events(safety assessment): There were no adverse events directly related to rehabilitation intervention in early postoperative rehabilitation of DDH.There were no adverse events directly related to rehabilitation intervention in the two groups at 3 months after intervention,such as hip joint redislocation,wound rupture,steel needle removal,osteotomy site displacement,and plate fracture.Conclusion:Based on the advantages of pediatric surgery-rehabilitation interdisciplinary,this study used multimodal assessment to determine the time of early rehabilitation intervention after DDH surgery through pre-test.And a randomized controlled trial was designed to evaluate the clinical outcomes from multiple dimensions such as structure,function,activity and participation.It was confirmed that the early rehabilitation intervention(10 days)after DDH surgery was safe and effective.And compared with the traditional 6 weeks after surgery,rehabilitation interventions can improve the limitation of hip range of motion of flexion and improve ADL ability.Although it does not show significant advantage in hip development and quality of life,the data show that hip development may be better and quality of life may be higher after early rehabilitation intervention.更多还原