Systematic evaluation of the efficacy and safety of collum
femoris preserving prosthesis in total hip arthroplasty

doi:10.3969/j.issn.2095-4344.2456

Abstract

Abstract:

BACKGROUND: Total hip arthroplasty with femoral neck prosthesis is being accepted by more and more doctors, but the effect of femoral neck prosthesis preservation or not on total hip arthroplasty is still uncertain.

OBJECTIVE: To systematically evaluate the efficacy and safety of collum femoris preserving prosthesis in total hip arthroplasty.

METHODS: CBM, CNKI, VIP, WanFang, PubMed, Embase and The Cochrane Library databases were searched systematically. The deadline was March 1, 2018. All clinical controlled trials collum femoris preserving prosthesis in total hip arthroplasty were collected and methodological quality was evaluated one by one. RevMan 4.2 software was used for systematic evaluation.

RESULTS AND CONCLUSION: (1) Four studies were included, involoing 302 patients. Because there were few studies and patients involved, and the outcome evaluation indicators were quite different, meta-analysis cannot be conducted, only descriptive systematic evaluation was performed. (2) Three studies compared the efficacy of two surgical methods in improving Harris score. Two of them considered that total hip arthroplasty with collum femoris preserving prosthesis was significantly better than total hip arthroplasty with non-collum femoris preserving prosthesis (P < 0.05). The other one considered that there was no significant difference between two surgical methods in improving Harris score (P > 0.05). (3) Two studies compared the efficacy of two surgical methods in improving the range of motion of the joint. One study showed that total hip arthroplasty with collum femoris preserving prosthesis was significantly better than total hip arthroplasty with non-prosthesis (P < 0.05). The other showed that there was no significant difference between the two surgical methods in improving the range of motion of the joint (P > 0.05). (4) One study showed that bone loss around the prosthesis in the total hip arthroplasty group with prosthesis was significantly less than that in the total hip arthroplasty group without collum femoris preserving prosthesis at 1 year postoperatively (P < 0.05). (5) One study found that the collum femoris preserving prosthesis in total hip arthroplasty group was superior to the non-collum femoris preserving prosthesis in total hip arthroplasty group in improving the Visual Analogue Scale at 1 year postoperatively (P < 0.05). (6) Two studies showed that no adverse prosthetic events such as loosening or sinking occurred at 1 year after total hip arthroplasty. (7) Two studies compared the differences in operation time and intraoperative bleeding volume, which showed no significant difference between two groups (P > 0.05). (8) One study found that the total amount of bleeding in total hip arthroplasty group with collum femoris preserving prosthesis was higher than that in total hip arthroplasty group without collum femoris preserving prosthesis (P < 0.05). (9) In summary, total hip arthroplasty with collum femoris preserving prosthesis has advantages in improving Harris score, decreasing the Visual Analogue Scale score and that bone loss around the prosthesis. More rigorous research is needed to increase the intensity of evidence.

Key words: collum femoris preserving prosthesis, total hip arthroplasty, pain, prostheisis loosening, systematic evaluation

CLC Number:

Huang Hetao, Pan Jianke, Yang Weiyi, Zeng Lingfeng, Liang Guihong, Liu Jun. Systematic evaluation of the efficacy and safety of collum femoris preserving prosthesis in total hip arthroplasty [J]. Chinese Journal of Tissue Engineering Research, 2020, 24(6): 962-967.

Figures/Tables 5

2.4.1 基线比较此次研究所纳入的4个临床研究，大部分都在试验前分别从年龄、性别、Harris评分等方面进行了基线资料的比较，相关基线资料比较差异无显著性意义，具有组间可比性。 2.4.2 随机化此次系统评价纳入的4个临床研究中，仅有2个研究对随机分组方法进行了描述[11-12]，其中1个研究运用区组随机方法进行了随机分组[12]，另1个研究则运用随机数字表法进行随机分组[11]。 2.4.3 分配方案隐藏此次系统评价纳入的4个临床研究中，仅有1个研究对分配方案隐藏方法进行了描述[12]，该研究采用按顺序编码、密封、不透光信封进行分配方案隐藏，其余3个研究均未提及分配方案隐藏方法。 2.4.4 盲法的实施此次系统评价纳入的4个临床研究中，仅有1个研究对盲法的实施进行了描述[12]，该研究采用双盲方法进行，但是否对结果评价人员采用盲法未明确提及。其余3个研究均未提及盲法。 2.4.5 偏倚随访偏倚：有1个研究报道了随访过程中的脱落病例[12]，并对脱落病例进行了意向治疗分析。选择性报告偏倚：纳入此次系统评价的4个研究均认为无选择性报道偏倚，所有研究中在方法部分设定的结局指标均在结果部分得到体现。 2.4.6 其他偏倚此次系统评价纳入的4个临床研究中，2个研究提及得到基金项目资助[11-12]，其中1个研究资助来自于荷兰Link公司[12]，1个研究为市级课题项目[11]。其中1个研究的效应指标表述不明确[14]，前后缺乏统一性，可能对研究结果产生较大影响，故判定为存在偏倚风险。综上所述，此次系统评价各纳入研究的质量有所差异，仅有1个研究属于高质量研究设计[12]。此外，4个研究的主要结局指标各有异同，因此不能进行定量的Meta分析，故此次研究仅进行定性的描述性系统评价。 2.5 临床主要疗效指标评价在VAN OLDENRIJK等[12]的前瞻性临床随机对照研究中，对150例(治疗组和对照组各75例)患者进行了观察，采用荷兰版的髋关节炎疗效评分标准作为主要结局指标进行疗效评价。在为期3个月的临床随访中，使用保留股骨颈假体组髋关节伤残和骨关节炎评分由术前36.6(95%CI：32.9-40.2)增至69.3(95%CI：66.4-72.1)，增加了32.7分，而常规假体组髋关节炎疗效评分由术前37.1(95%CI：33.9-40.3)增至术后的73.4(95%CI：70.3-76.4)，增加了36.3分，2组髋关节伤残和骨关节炎评分比较差异无显著性意义(P > 0.05)。该研究结果提示，在3个月内2种假体类型在改善患者髋关节残疾与骨关节炎评分方面差异可能无显著性意义。在陈希聪等[11]的临床研究中，对72例患者进行了临床随机对照试验，采用假体周围骨密度作为主要结局指标进行疗效评价，结果显示在全髋关节置换术后第3周，假体周围骨密度测定结果2组间比较差异无显著性意义(P > 0.05)。与术后第3周的假体周围骨密度比较，在术后第6个月及第12个月，使用保留股骨颈假体组股骨近端各个测量区的骨密度均未见显著变化(P > 0.05)；而使用传统非保留股骨颈假体组在ROI 1区、ROI 2区术后第6，12个月的骨密度均较术后3周时明显减小，差异有显著性意义(P < 0.05)。使用保留股骨颈假体组术后第6及12个月ROI 1区的平均骨密度变化率显著高于非保留股骨颈假体组，差异有显著性意义(P < 0.05)；此外，使用保留股骨颈假体组术后第12个月ROI 7区的平均骨密度变化率与非保留股骨颈假体比较差异有显著性意义(P < 0.05)。该结果提示，与传统非保留股骨颈假体全髋关节置换相比，使用保留股骨颈假体全髋关节置换术后1年其假体周围骨量丢失更少，骨密度水平更高，股骨近端的应力载荷传递效果更好。在白胜辉[13]的研究中，对50例患者(治疗组与对照组各30髋)进行了临床对照试验，采用Harris评分、髋关节活动度评价、目测类比评分、X射线片等作为主要结局指标进行疗效评价。结果显示2组术后3个月Harris评分、关节活动度、目测类比评分经统计学检验，P值分别为0.055，0，0.813，2组Harris评分、目测类比评分比较差异无显著性意义(P > 0.05)，而使用保留股骨颈假体组的关节活动度优于非保留股骨颈假体组患者。2组术后12个月及36个月Harris评分、关节活动度、目测类比评分比较差异均有显著性意义(P < 0.05)，使用保留股骨颈假体组的Harris评分、关节活动度均明显高于非保留股骨颈假体组，目测类比评分低于非保留股骨颈假体组。运用X射线进行影像学评价，2组随访至术后36个月均未发现假体松动、下沉等不良事件。该结果提示，就术后中近期疗效而言，保留股骨颈型全髋关节置换手术在改善术后患者Harris评分、提高关节活动度、降低目测类比评分方面均明显优于非保留股骨颈型全髋关节置换。在陈捷[14]的研究中，对30例(试验组10例，对照组20例)患者进行了临床观察，采用Harris评分、关节活动度、X射线片等作为主要结局指标进行疗效评价。结果显示2组术后Harris评分比较差异有显著性意义(P < 0.05)，而2组患者在术后关节活动度、X射线评价等方面比较差异无显著性意义(P > 0.05)。该结果提示，股骨颈保留型全髋关节置换与非股骨颈保留型全髋关节置换在改善Harris评分方面具有一定优势，而在改善关节活动度等方面无明显优势。值得注意的是，该文献在方法学质量评价上存在一定偏倚，需客观评价其研究结果。 2.6 临床次要疗效指标评价 VAN OLDENRIJK等[12]的研究结果显示，2组在SF-12、Pain and the EQ-5D等的评估比较中，差异无显著性意义(P > 0.05)。白胜辉[13]的研究结果提示，2组在手术时间、术中出血量方面比较差异无显著性意义(P > 0.05)，而在术后累计出血量方面，股骨颈保留型假体组累计出血量高于非股骨颈保留型假体组。陈捷[14]的研究结果提示，2组在手术时间、术中出血量、住院时间方面比较差异无显著性意义(P > 0.05)。综上所述，考虑2种手术方式在手术时间、术中出血量方面没有明显差异，而在住院时间方面是否存在显著差异尚不确定，需要更高质量的研究加以验证。 2.7 安全性评价在陈捷[14]的研究随访过程中，非股骨颈保留型全髋关节置换术中出现假体周围骨折病例1例，术后出现双下肢不等长病例2例、术后关节脱位病例1例，而保留股骨颈假体组无不良事件发生，该研究总样本量为30例，不良事件发生率相对偏高，可能与围术期评估、手术操作技术及术后康复锻炼有关。其余3个样本量较大的临床研究中均未出现不良安全事件[11-13]，尚需进行更大样本、更严格设计的临床随机对照试验来对全髋关节置换的安全性进行客观评价。 "

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