Li Jingchun,Liu Yanhan,Li Yiqiang,et al.A multicenter prospective non-randomized controlled protocol on timing and indications of pelvic osteotomy for residual acetabular dysplasia after closed reduction of developmental dislocation of the hip[J].Journal of Clinical Pediatric Surgery,2024,(06):527-534.[doi:10.3760/cma.j.cn101785-202405072-005]
发育性髋关节脱位闭合复位后残余髋臼发育不良骨盆截骨时机与指征的多中心前瞻性非随机对照试验研究方案
- Title:
- A multicenter prospective non-randomized controlled protocol on timing and indications of pelvic osteotomy for residual acetabular dysplasia after closed reduction of developmental dislocation of the hip
- Keywords:
- Developmental Dysplasia of the Hip; Hip Dislocation; Congenital; Closed Reduction; Residual Acetabulalr Dysplasia; Osteotomy; Pelvis; Clinical Protocols; Multicenter Studies as Topic
- 摘要:
- 全身麻醉下闭合复位加髋人位石膏固定是治疗24月龄以下发育性髋关节脱位(developmental dislocation of the hip,DDH)的通用方法,但闭合复位后仍有约1/3的患儿存在残余髋臼发育不良。尽管骨盆截骨术正越来越多地应用于残余髋臼发育不良的治疗,但其手术时机和手术指征仍不明晰。本研究拟通过一项多中心前瞻性非随机对照试验探讨DDH闭合复位后残余髋臼发育不良的手术干预时机和指征。研究设计拟纳入283例DDH闭合复位后残余髋臼发育不良患儿,包括观察组183例,手术组(采用骨盆截骨术)100例。手术组根据患儿年龄采用Salter、Pemberton、骨盆三联或髋臼周围截骨术。所有患儿随访10年,拟在DDH闭合复位后8个时间点(闭合复位术后1、2、3、4、5~6、7~8、9~10年以及10年以上)拍摄髋关节正位X线片,测量髋臼指数 (acetabular index,AI)、中心边缘角 (center-edge angle of wiberg,CEA)和Reimer 指数 (Reimer’s index,RI),根据末次随访时正位X线片上髋关节Severin分级分为满意组(Severin 分级为Ⅰ、Ⅱ级)和不满意组(Severin 分级为Ⅲ、Ⅳ级),利用Logistic回归和Cox回归分析残余髋臼发育不良的风险因素,比较两组患儿AI、CEA、RI及Severin 分级情况。这一多中心前瞻性研究可以为DDH闭合复位后残余髋臼发育不良的手术干预时机和指征提供循证医学证据。
- Abstract:
- Closed reduction under general anesthesia and plaster fixation in human position are commonly applied for treating developmental dislocation of the hip (DDH) under an age of 24 months.However,around one-third of patients still experience residual acetabular dysplasia after closed reduction.Although pelvic osteotomy is widely utilized for residual acetabular dysplasia,its accurate surgical timing and indications have remained elusive.This study was designed to explore timing and indications of surgical intervention for residual acetabular dysplasia after closed reduction of DDH through a multicenter,prospective and non-randomized controlled trial.There were 183 children in observation group and 100 in pelvic surgical intervention group.The surgical group underwent Salter and Pemberton,Triple pelvic or Periacetabular osteotomy based upon age.The follow-up period was at least 10 years.Anteroposterior radiographs of hip joint were taken at 8 timepoints of 1/2/3/4/5-6/7-8/9-10/>10 years post-reduction surgery for measuring the values of acetabular index (AI),center-edge angle of wiberg (CEA) and Reimer’s index (RI).According to the Severin grading of the last follow-up,they were assigned into two groups of satisfactory (grade Ⅰ/Ⅱ) and unsatisfactory (grade Ⅲ/Ⅳ).Logistic and COX regressions were employed for examining the risk factors for residual acetabular dysplasia and comparing the clinical values of AI,CEA,RI and Severin grades between two groups.This study provided evidence-based medical evidence for timing and indications of surgical interventions for residual acetabular dysplasia after closed reduction of DDH.
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备注/Memo
收稿日期:2024-05-28。
基金项目:广州医科大学广州市妇女儿童医疗中心医学系统生物学实验室临床研究基金(GWCMC2020-6-005)
通信作者:徐宏文,Email:xuhongwen@gwcmc.org