中国组织工程研究

中国组织工程研究 ›› 2016, Vol. 20 ›› Issue (48): 7261-7266.doi: 10.3969/j.issn.2095-4344.2016.48.017

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

骨水泥型股骨柄人工股骨头置换治疗老年骨质疏松股骨颈骨折的可行性：随机对照临床试验方案

任 荣，李凌伟，郭启发   

  1. 青海大学附属医院创伤骨科，青海省西宁市 810001
  • 修回日期:2016-09-17 出版日期:2016-11-25 发布日期:2016-11-25
  • 通讯作者: 任荣，青海大学附属医院创伤骨科，青海省西宁市 810001
  • 作者简介:任荣，男，1980年生，青海省人，汉族，硕士，主治医师，主要从事四肢、脊柱创伤等方面的临床研究。
  • 基金资助:

    青海省科技支撑计划项目

Feasibility of implantation of a cemented femoral stem in the treatment of osteoporotic femoral neck fracture in elderly patients: study protocol of a randomized controlled trial

Ren Rong, Li Ling-wei, Guo Qi-fa   

  1. Department of Traumatic Orthopedics, Qinghai University Affiliated Hospital, Xining 810001, Qinghai Province, China
  • Revised:2016-09-17 Online:2016-11-25 Published:2016-11-25
  • Contact: Ren Rong, Department of Traumatic Orthopedics, Qinghai University Affiliated Hospital, Xining 810001, Qinghai Province, China.
  • About author:Ren Rong, Master, Attending physician,Department of Traumatic Orthopedics, Qinghai University Affiliated Hospital, Xining 810001, Qinghai Province, China
  • Supported by:

    This work was supported by the Science and Technology Fund of Qinghai Province of China

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摘要：

文章快速阅读：

 
 
 
文题释义：
骨水泥型股骨柄：是一种生物型股骨柄翼型锻造钛合金，表面带有羟基磷灰石涂层，球头为金属材质。适用于不能用其他方法治疗的严重髋关节疾病，如老年骨质疏松股骨颈骨折。
老年骨质疏松股骨颈骨折：指有骨质疏松、骨质变脆的老年人在只是轻微的外伤，如走路滑倒、大腿突然扭转等引起的股骨颈骨折。股骨颈骨折后，主要症状是髋部出现疼痛，髋关节的任何活动，都会使疼痛加剧。同时患肢也不能活动、不能站立行走，髋关节处出现肿胀、压痛。但也有少数患者在骨折刚开始时疼痛不明显，还可以走路，极易漏诊，但几天后疼痛加重，甚至完全不能走路。如果骨折处出现错位，还会出现患腿有缩短、扭转等变形。
 
摘要
背景：临床上，对于老年股骨颈骨折手术治疗最大的难题就是患者一般并发骨质疏松。因此，内固定手术的治疗要点就是重塑骨的空间结构，加强断裂的骨小梁，从而做到在生物力学上的坚强固定。在老年骨质疏松性股骨颈骨折的治疗中，虽然经皮空心加压螺钉内固定为目前的首选手术方法，但对于并发骨质疏松的老年股骨颈骨折患者，手术用钉在股骨颈内的把持力不够强大，可能会造成固定的不牢靠，因此，有研究者主张用人工假体关节置换治疗老年股骨颈骨折，但对于已发生股骨头缺血性坏死的骨质疏松股骨颈近端骨折老年患者，其远期疗效尚不明确。
目的：比较骨水泥型股骨柄与空心螺钉内固定治疗已发生股骨头缺血性坏死的骨质疏松股骨颈近端骨折的有效性和安全性。
方法：研究为单中心、前瞻性、随机平行对照研究。试验在中国青海，青海大学附属医院完成；缺血性股骨头坏死骨质疏松股骨颈骨折老年患者100例纳入研究，随机给予空心螺钉内固定治疗(n=50)或人工假体股骨柄人工股骨头置换治疗(n=50)。研究方案取得中国青海大学附属医院伦理委员会的书面批准(批准号：QHY1019W)，且符合世界医学会制订的《赫尔辛基宣言》，并已在ClinicalTrials.gov注册(NCT02901938)。患者或及监护人对试验内容知情同意。
结果与结论：试验的主要结局为基线(术前)、术后1，6，12个月Harris髋关节评分评估的髋关节功能；次要结局为基线(术前)、术后1，6，12个月的目测类比疼痛评分评估的疼痛；其他观察指标为术后6和12个月股骨头塌陷及无菌坏死发生率、骨折不愈合率、假体无菌性松动发生率和假体周围感染发生率，以评估人工假体材料与宿主的组织相容性反应。目前关于手术治疗已发生股骨头缺血性坏死的骨质疏松股骨颈近端骨折老年患者远期疗效的随机对照研究较缺乏。试验首次从空心螺钉内固定和骨水泥型股骨柄假体置入治疗已发生股骨头缺血性坏死的骨质疏松股骨颈骨折老年患者的有效性和安全性角度，通过12个月的随访，以严谨的随机对照试验研究，评估两种植入物治疗老年股骨头缺血性骨质疏松股骨颈骨折的可行性。

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: 00000-0002-2357-5048(任荣)

关键词: 骨科植入物, 人工假体, 临床试验, 空心螺钉, 股骨柄, 缺血性坏死, 骨质疏松, 股骨颈骨折, 内固定, 人工假体, 老年, 随机对照研究

Abstract:

BACKGROUND: Osteogenesis is a common problem after surgery for femoral neck fracture in elderly patients. Internal fixation for the treatment of femoral neck fracture should be performed to optimize bone remodeling and strengthen fractured bone trabeculae, with the aim of achieving strong fixation from the perspective of biomechanics. Percutaneous internal fixation with cannulated compression screws has become a preferred treatment method of osteoporotic femoral neck fracture in elderly patients, but the insufficient holding power of the screws used in the femoral neck does not lead to strong fixation. An alternative, joint prosthesis, is recommended for the repair of femoral neck fracture in elderly patients. However, its long-term therapeutic effects in the treatment of osteoporotic fracture of proximal femoral neck remain poorly understood in patients with avascular necrosis of the femoral head.

OBJECTIVE: To investigate the the safety and effectiveness of implantation of cemented femoral stem versus percutaneous internal fixation with cannulated compression screws in the treatment of osteoporotic femoral neck fracture in elderly patients.
METHODS: A single-center, prospective, randomized controlled, open-label trial will be performed in Qinghai University Affiliated Hospital, Qinghai, China. One hundred patients with avascular necrosis of the femoral head complicated by osteoporotic femoral neck fracture will be randomly assigned to two groups. Group 1 will undergo percutaneous internal fixation with cannulated compression screws (n=50) and group 2 will be implanted with cemented femoral stem (n=50). This study protocol has been approved by the Medical Ethics Committee of Qinghai University Affiliated Hospital in China and will be performed in accordance with the guidelines of the Declaration of Helsinki, formulated by the World Medical Association. Signed informed consent regarding trial procedure and treatment will be obtained from each patient or their guardians. This trial was registered at ClinicalTrials.gov (NCT02901938).
RESULTS AND CONCLUSION: The primary outcome measure of this study is hip joint function as assessed by Harris hip scores taken at baseline (prior to surgery), 1, 6 and 12 months after surgery. The secondary outcome measure is hip joint pain score on a Visual Analogue Scale at baseline (prior to surgery), 1, 6 and 12 months after surgery. Other outcome measures include the percentage of patients presenting with femoral head collapse, bone non-union, sterile prosthesis loosening or peri-prosthesis infection 6 and 12 months after surgery. These will be used to evaluate the histocompatibility of biomaterial with the host tissue. Randomized controlled studies are scarce on the long-term therapeutic effects of surgery in the treatment of osteoporotic femoral neck fracture in elderly patients presenting with avascular necrosis of the femoral head. This will be the first study to investigate the feasibility of implantation of cemented femoral stem versus percutaneous internal fixation with cannulated compression screws in the treatment of osteoporotic femoral neck fracture complicated by avascular necrosis of the femoral head. It will test from the perspectives of safety and efficacy through a stringent randomized controlled trial based on a 12-month follow-up evaluation. 

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: Clinical Trial, Bone Nails, Hip Prosthesis, Femur Head Necrosis, Osteoporosis, Hip Fractures, Internal Fixators, Aged, Randomized Controlled Trial

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