He Jinpeng,Zheng Chen,Mei Haibo,et al.Necessity of femoral osteotomy in DDH of early age group:a prospective randomized control study protocol(FSODDH)[J].Journal of Clinical Pediatric Surgery,2019,18(04):282-287.[doi:10.3969/j.issn.1671-6353.2019.04.007]
低龄DDH患儿初次开放复位术中股骨截骨必要性的前瞻性随机对照试验研究方案
- Title:
- Necessity of femoral osteotomy in DDH of early age group:a prospective randomized control study protocol(FSODDH)
- Keywords:
- Developmental Dislocation of The Hip; Femur; Osteotomy/MT; Prospective Studies; Randomized Controlled Trials; Research Design
- 分类号:
- R181.2;R726.8;R687.3+1
- 摘要:
- 回顾性研究发现，股骨截骨术并非低龄DDH患儿手术治疗所必须的，而应根据患儿具体情况合理选择；本研究通过多中心前瞻性研究进一步探讨对于18个月至3岁DDH患儿是否要行股骨截骨术。FSODDH项目为一项多中心前瞻性随机对照临床试验研究。研究设计拟招募200名单侧低龄DDH患儿，随机分成股骨截骨组（n=100）和股骨不截骨组（n=100）。股骨截骨组患儿全部采取髋关节开放复位术、骨盆截骨术及股骨截骨术治疗；股骨不截骨组患儿全部采取髋关节开放复位术及骨盆截骨术治疗；术后定期随访至少2年。收集术前、术后1周、术后1个月、术后3个月、术后6个月、术后1年及术后2年的髋关节正位X线影像资料，比较两组患儿的髋臼指数、股骨头坏死率、再脱位率、术中出血量、手术时间和住院天数等临床指标。这一多中心前瞻性研究将能为低龄DDH患儿是否需行股骨截骨术提供循证医学证据。
- Abstract:
- Various treatments are available for developmental dislocation of the hip (DDH).It is still controversial whether femoral osteotomy is necessary for DDH children aged 18-36 months.Therefore CMPOS intended to further clarify the need for femoral osteotomy on the basis of a retrospective study and a multi-center prospective study.A total of 200 early-age unilateral DDH children were recruited and randomized into femoral osteotomy (n=100) and non-osteotomy (n=100) groups.Hip joint open reduction was performed along with pelvic/femoral osteotomy for the former group and hip joint open reduction plus pelvic osteotomy for the latter group.The postoperative follow-up period was at least 2 years.Frontal view radiographic images were collected at pre-operation and 1 week,1 month,3 months,6 months,1 year and 2 years post-operation.Clinical parameters,such as acetabular index (AI),rate of AVN,rate of re-dislocation,intraoperative hemorrhagic loss,operation duration and hospitalization stay,were compared for two groups.This multi-center prospective study may provide a reliable reference for this controversy.
参考文献/References:
1 Cooper AP,Doddabasappa SN,Mulpuri K.Evidence-based management of developmental dysplasia of the hip[J].Orthop Clin North Am,2014,45(3):341-354.DOI:10.1016/j.ocl.2014.03.005.
2 Gholve PA,Flynn JM,Garner MR,et al.Predictors for secondary procedures in walking DDH[J].J Pediatr Orthop,2012,32(2):282-289.DOI:10.1097/BPO.0b013e31824b21a6.
3 Zadeh HG,Catterall A,Hashemi-Nejad A,et al.Test of stability as an aid to decide the need for osteotomy in association with open reduction in developmental dysplasia of the hip[J].J Bone Joint Surg Br,2000,82(1):17-27.
4 Arslan H,Sucu E,Ozkul E,et al.Should routine pelvic osteotomy be added to the treatment of DDH after 18 months?[J].Acta Orthop Belg,2014,80(2):205-210.
5 Schoenecker PL,Anderson DJ,Capelli AM.The acetabular response to proximal femoral varus rotational osteotomy.Results after failure of post-reduction abduction splinting in patients who had congenital dislocation of the hip[J].J Bone Joint Surg Am,1995,77(7):990-997.
6 Sankar WN,Tang EY,Moseley CF.Predictors of the need for femoral shortening osteotomy during open treatment of developmental dislocation of the hip[J].J Pediatr Orthop,2009,29(8):868-871.DOI:10.1097/BPO.0b013e3181c29cb2.
7 Alassaf N.Predictors of femoral shortening for pediatric developmental hip dysplasia surgery:an observational study in 435 patients[J].Patient Saf Surg,2018,12:29.DOI:10.1186/s13037-018-0176-y.
8 Tezeren G,Tukenmez M,Bulut O,et al.The surgical treatment of developmental dislocation of the hip in older children:a comparative study[J].Acta Orthop Belg,2005,71(6):678-685.
9 何金鹏,梅海波,徐宏文,等.18个月到3岁发育性髋关节脱位患儿初次开放复位股骨截骨与不截骨近期疗效的比较研究[J].中华小儿外科杂志,2016,37(12):888-892.DOI:10.3760/cma.j.issn.0253-3006.2016.12.003. He JP,Mei HB,Xu HW,et al.Comparative study of immediate efficacies for initial open reduction femoral osteotomy versus non-osteotomy in developmental dysplasia of the hip in children aged 18-36 months[J].Chin J Pediatr Surg,2016,37(12):888-892.DOI:10.3760/cma.j.issn.0253-3006.2016.12.003.
10 Bohm P,Brzuske A.Salter innominate osteotomy for the treatment of developmental dysplasia of the hip in children:results of seventy-three consecutive osteotomies after twenty-six to thirty-five years of follow-up[J].J Bone Joint Surg Am,2002,84-A:178-186.
11 Thomas SR,Wedge JH,Salter RB.Outcome at forty-five years after open reduction and innominate osteotomy for late-presenting developmental dislocation of the hip[J].J Bone Joint Surg Am,2007,89(11):2341-2350.DOI:10.2106/JBJS.F.00857.
12 Wu KW,Wang TM,Huang SC,et al.Analysis of osteonecrosis following Pemberton acetabuloplasty in developmental dysplasia of the hip:long-term results[J].J Bone Joint Surg Am,2010,92(11):2083-2094.DOI:10.2106/JBJS.I.01320.
13 Aydin A,Kalali F,Yildiz V,et al.The results of Pembe-rton’s pericapsular osteotomy in patients with developmental hip dysplasia[J].Acta Orthop Traumatol Turc,2012,46(1):35-41.
14 晏建森,南国新.儿童发育性髋关节发育不良的手术治疗进展[J].临床小儿外科杂志,2018,17(10):731-735.DOI:10.3969/j.issn.1671-6353.2018.10.003. Yan JS,Nan GX.Advances in surgical therapy for developmental dysplasia of the hip in children[J].J Clin Ped Sur,2018,17(10):731-735.DOI:10.3969/j.issn.1671-6353.2018.10.003.
15 Mootha AK,Saini R,et al.Do we need femoral derotation osteotomy in DDH of early walking age group? A clinico-radiological correlation study[J].Arch Orthop Trauma Surg,2010,130(7):853-858.DOI:10.1007/s00402-009-1020-8.
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备注/Memo
收稿日期:2018-12-29。
通讯作者:邵景范,Email:shaojf65@126.com