中国组织工程研究

中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (53): 7985-7991.doi: 10.3969/j.issn.2095-4344.2016.53.012

• 骨与关节临床实践 clinical practice of the bone and joint • 上一篇    下一篇

保留股骨颈型髋关节假体置换中假体周围骨折对髋关节功能恢复的影响：前瞻性、单中心、自身对照、2年随访临床试验

秦 迪，韩永台，李会杰   

  1. 河北医科大学第三医院骨病科，河北省石家庄市 050051
  • 修回日期:2016-10-28 出版日期:2016-12-23 发布日期:2016-12-23
  • 通讯作者: 韩永台，硕士，主任医师，教授，硕士生导师。河北医科大学第三医院骨病科，河北省石家庄市 050051
  • 作者简介:秦迪，男，湖北省人，汉族，1982年生，硕士，2009年河北医科大学毕业，主治医师。
  • 基金资助:

    河北省医学科学研究重点课题计划项目(20150267)

Effect of periprosthetic fracture on hip function after femoral neck-preserving total hip arthroplasty: study protocol for a prospective, single-center, self-controlled trial with 2-year follow-up

Qin Di, Han Yong-tai, Li Hui-jie   

  1. Department of Bone Diseases, Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China
  • Revised:2016-10-28 Online:2016-12-23 Published:2016-12-23
  • Contact: Han Yong-tai, Master, Chief physician, Professor, Master’s supervisor, Department of Bone Diseases, Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China
  • About author:Qin Di, Master, Attending physician, Department of Bone Diseases, Third Hospital of Hebei Medical University, Shijiazhuang 050051, Hebei Province, China
  • Supported by:

    the Medical Science Research Project of Hebei Province in China, No. 20150267

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摘要：

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文题释义：
保留股骨颈型髋关节假体：是德国LINK公司与意大利著名的人工关节专家Pipino教授合作研发的保留股骨颈的生物固定型假体柄。充分考虑了髋关节的生物力学特点，即应力传导集中在股骨颈的周围，使股骨颈周围的骨质成为最坚强的骨质。
股骨头坏死：是一个病理演变过程，初始发生在股骨头的负重区，应力作用下坏死骨骨小梁结构发生损伤即显微骨折以及随后针对损伤骨组织的修复过程。造成骨坏死的原因不消除，修复不完善，损伤-修复的过程继续，导致股骨头结构改变、股骨头塌陷、变形，关节炎症，功能障碍。
 
摘要
背景：研究表明，保留股骨颈型髋关节置换可降低髋关节置换患者置换后并发症，为远期翻修保留更多骨量，但在术中易出现股骨假体周围骨折，严重影响患者置换后髋关节功能恢复。
目的：试验采用前瞻性分析方法，分析保留股骨颈型髋关节置换中发生假体周围骨折的危险因素，提出预防措施，以期降低该并发症的发生率。
方法：研究为前瞻性、单中心、自身对照、2年随访、开放性临床试验方案，在中国河北省石家庄市，河北医科大学第三医院骨病科完成。纳入保留股骨颈型髋关节置换中假体周围骨折患者25例，对其置换前及置换后的X射线片和CT检测影像学指标参数进行分析。试验的主要观察指标为置换前和置换后6，12，24个月的髋关节功能Harris评分评估患者置换后髋关节功能恢复情况。试验的次要观察指标为关节置换中患者AAOS假体周围骨折分型结果，评估患者股骨假体周围骨折严重程度；置换前和置换后6，12，24个月患者影像学指标参数评估骨折愈合情况，包括中近端股骨骨折髓腔参数：小转子中点上方20 mm髓腔宽度、小转子中点髓腔宽度、小转子中点下方20 mm髓腔宽度、骨折线髓腔及对应假体宽度，转子间窝距离，股骨颈干角，前倾角，股骨颈长度，患者假体末端与髓腔间距冠状径之比、股骨距高度；试验的其他观察指标为影响保留股骨颈型髋关节置换中发生假体周围骨折患者髋关节功能恢复危险因素的多元Logistic回归分析结果及置换后24个月的不良反应发生率。试验于2016年11月24日在北美临床试验注册中心注册(NCT02981823)；试验经中国河北省石家庄市河北医科大学第三医院伦理委员会批准(KE2016-011-1)，研究方案中项目符合世界医学会制定的《赫尔辛基宣言》的要求；参与者本人对治疗方案和过程均知情同意，并签署知情同意书。
讨论：试验详细分析保留股骨颈型髋关节置换中假体周围骨折的原因，探讨影响患者髋关节功能恢复的危险因素，以期为降低保留股骨颈型髋关节置换中假体周围骨折的发生率以供参考依据。

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

ORCID: 0000-0002-1770-4173(韩永台)

关键词: 骨科植入物, 骨植入物, 临床试验, 髋关节置换, X射线, CT检查, 多元Logistic回归分析, 髋关节功能Harris评分髓腔, 髋臼, 危险因素, 不良反应, 自身对照试验

Abstract:

BACKGROUND: Total hip replacement with a collum femoris preserving (CFP) short stem prosthesis can reportedly reduce postoperative complications and preserve maximum bone tissue for long-term revision. However, CFP replacement has a relatively high risk of intraoperative periprosthetic fractures that can seriously harm hip function recovery.

OBJECTIVE: To analyze risk factors for periprosthetic fractures and develop preventive measures to reduce postoperative complications.
METHODS: A prospective, single-center, self-controlled, open-label clinical study with 2-year follow-up will be carried out at the Department of Orthopedics, Third Hospital of Hebei Medical University, Shijiazhuang, Hebei Province, China. We will analyze imaging data from 25 patients who undergo total hip replacement with the CFP prosthesis. Primary outcome measure is hip function recovery as assessed by Harris hip score preoperatively and 6, 12, and 24 months postoperatively. Secondary outcome measures include fracture severity as assessed by periprosthetic fracture classification according to the American Academy of Orthopaedic Surgeons guidelines, and bone healing as assessed by CT and radiographic findings preoperatively and 6, 12, and 24 months postoperatively, including parameters of the proximal and mesal medullary cavity of the fractured femur (width of the medullary cavity at the point 20 mm above the midpoint of the small trochanter, at the midpoint of the small trochanter, at the point 20 mm below the midpoint of the small trochanter, and at the fracture line; width of the corresponding prostheses), intertrochanteric width, femoral neck-stem angle, femoral neck anteversion, femoral neck length, ratio of the distal end of the prosthesis to the medullary space, and height of the femoral calcar. Other outcome measures are multiple logistic regression analysis results of risk factors for periprosthetic fracture during hip replacement, and the incidence of adverse events within 24 months postoperatively. This study was registered at ClinicalTrials.gov (NCT 02981823) on 24 November 2016. Approved by the Ethics Committee of the Third Hospital of Hebei Medical University, China (approval number: KE2016-011-1), the study protocol will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Written informed consent will be obtained from all participants prior to the trial.
DISCUSSION: This study will be expected to provide references for reducing the incidence of periprosthetic fracture during hip replacement with the CFP prosthesis.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

Key words: Tissue Engineering, Arthroplasty, Replacement, Hip, Acetabulum

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