生物型与骨水泥型单髁置换术的早期效果比较

doi:10.3877/cma.j.issn.1674-134X.2023.01.019

目的

研究比较生物型与骨水泥型单髁置换术的早期临床效果。

方法

收集2018年9月至2019年4月在同济大学附属杨浦医院符合牛津第三代单髁置换(Oxford Ⅲ)适应证的终末期膝关节炎的患者64例，其中男性17例(17膝)，女性47例(47膝)。采用随机数字表法分为生物型单髁置换组(生物组)与骨水泥型单髁置换组(骨水泥组)，每组各32例。由两名独立于手术团队的研究员统计两组患者的一般资料、骨密度、活动范围(ROM)、视觉模拟评分(VAS)、牛津膝关节评分(OKS)、美国膝关节学会评分(AKSS)、手术时间、并发症以及影像学检查结果。组间比较采用t检验、卡方检验或Mann-Whitney U检验。

结果

所有患者均获得至少1年的随访，生物组与骨水泥组患者术前基线数据差异无统计学意义。末次随访时，生物组与骨水泥组ROM(Z＝－1.088、－1.152，均为P<0.05)、VAS(Z＝－0.063、－1.113，均为P<0.05)、OKS(Z＝－1.602、－1.174，均为P<0.05)、AKSS-O(Z＝－0.558、－1.122，均为P<0.05)以及AKSS-F(Z＝－0.034、－0.621，均为P<0.05)均较术前显着改善，而组间差异没有统计学意义(均为P>0.05)。生物组手术时间少于骨水泥组(t＝－16.124，P<0.001)。3例生物组分别于术后4、6周和6个月发生胫骨平台骨折，皆为非暴力性。其余患者无术后感染、深静脉血栓、假体位置不良、松动、垫片过度磨损、脱位等不良事件。两组之间术后并发症发生差异无统计学意义(P>0.05)。

结论

生物型単髁置换术早期临床疗效与骨水泥型相似，并且操作更简单、手术时间更短，值得进一步探究。

关键词: 骨关节炎，膝, 关节成形术，置换，膝, 治疗结果

Objective

To study and compare the early clinical efficacy of cementless and cemented unicompartmental knee replacements.

Methods

A prospective study was conducted on 64 patients with end-stage knee osteoarthritis meeting the indications of Oxford III unicompartmental knee replacement at Orthopedic Department, Yangpu Hospital, Tongji University from September 2018 to April 2019.There were 17 males (17 knees) and 47 females (47 knees). The patients were randomly divided into two groups with the random number table: cementless unicompartmental knee replacement group (cementless group) and cemented unicompartmental knee replacement group (cemented group), 32 cases in each group. The general information, bone mineral density, range of motion (ROM), visual analogue scale (VAS), Oxford knee score (OKS), American knee association score (AKSS), operation time, complications and imaging results of the two groups were collected by two researchers who were independent of the surgical team. T test, chi square test or Mann-Whitney U test were used to compare the data between the two groups.

Results

All the patients were followed up for at least one year. There was no difference in baseline data between the cementless group and the cemented group. The clinical outcomes were improved at the last follow-up compared with pre-operation: ROM(Z=-1.088, -1.152, both P<0.05), VAS(Z=-0.063, -1.113, both P<0.05), OKS(Z=-1.602, -1.174, both P<0.05), AKSS-O(Z=-0.558, -1.122, both P< 0.05) and AKSS-f(Z=-0.034, -0.621, both P<0.05), but no statistically significant difference was found between the two groups (all P>0.05). The operation time of cementless group was less than that of cemented group (t=-16.124, P <0.001). In the cementless group, three cases of nonviolent fracture of tibial plateau occurred in four weeks, six weeks and six months after operation.There was no other complication such as postoperative infection, deep vein thrombosis, poor prosthesis position, prosthesis loosening, excessive wear of bearing or dislocation found after the operation. There was no statistically significant difference in postoperative complications between the two groups (P>0.05).

Conclusion

Early clinical efficacy of cementless unicompartmental knee replacement is similar to that of cemented, and it is worth further exploration due to its simpler operation and shorter surgical time.

Key words: Osteoarthritis, knee, Arthroplasty, replacement, knee, Treatment outcome

图1 生物型与骨水泥型牛津单髁器械及假体区别。图A为龙骨镐，左侧为生物型、右侧为骨水泥型；图B为龙骨锯，左侧为生物型、右侧为骨水泥型；图C为胫骨平台假体，左侧生物型的龙骨较右侧骨水泥型更宽；图D为股骨假体，左侧生物型双柱较右侧骨水泥型更粗；图E为胫骨假体背面，图F为股骨假体背面，可见左侧生物型假体背面均覆盖多孔钛及羟基磷灰石双喷涂层

Figure 1 Difference between cementless and cemented unicompartmental knee replacement instrumentation and prosthesis. A shows the keel pick, the left side is cementless and the right side is cemented; B shows the keel saw, the left side is cementless and the right side is cemented; C shows the tibial plateau prosthesis, the keel of the left side cementless is wider than that of the right side cemented; D shows the femoral prosthesis, the left side cementless double column is thicker than that of the right side cemented; E shows the back of the tibial prosthesis；F shows the back of the femoral prosthesis, it can be seen that the back of cementless prosthesis is covered with porous titanium and hydroxyapatite double spray layer

表1 两组患者一般资料比较

Table 1 Comparison of general information between two groups of patients

组别Group	例数Case number	年龄Age[岁，(±s)]	性别Gender(男/女)(male/female)	BMI[kg/m²，(±s)]	骨密度Bone density(±s)	手术部位(左/右)Site(left/right)
生物组Cementless group	32	65.8±7.6	6/26	26.8±4.4	－0.9±0.9	16/16
骨水泥组Cemented group	32	68.3±7.6	11/21	25.2±3.5	－1.1±0.8	17/15
统计值		t＝－1.298	χ²＝2.003	t＝1.556	t＝0.966	χ²＝0.061
P值		>0. 05	>0. 05	>0. 05	>0. 05	>0. 05

表1 两组患者一般资料比较

Table 1 Comparison of general information between two groups of patients

组别Group	例数Case number	年龄Age[岁，(±s)]	性别Gender(男/女)(male/female)	BMI[kg/m²，(±s)]	骨密度Bone density(±s)	手术部位(左/右)Site(left/right)
生物组Cementless group	32	65.8±7.6	6/26	26.8±4.4	－0.9±0.9	16/16
骨水泥组Cemented group	32	68.3±7.6	11/21	25.2±3.5	－1.1±0.8	17/15
统计值		t＝－1.298	χ²＝2.003	t＝1.556	t＝0.966	χ²＝0.061
P值		>0. 05	>0. 05	>0. 05	>0. 05	>0. 05

图2 生物组与骨水泥组膝关节功能随时间变化。图A为两组AKSS-F评分随时间变化义；图B为两组AKSS-O评分随时间变化；图C为两组OKS评分随时间变化；图D为两组VAS评分随时间变化注：各评分两组间比较差异无统计学意义(P>0.05)

Figure 2 Changes in knee function over time in the cementless and cemented groups. A is the changes of AKSS-F scores over time in the two groups; B is the changes of AKSS-O scores over time in the two groups; C is the changes of OKS scores over time in the two groups; D is the changes of VAS scores over time in the two groups

表2 两组患者术前及末次随访时临床功能评分比较[M(P₂₅，P₇₅)]

Table 2 Comparison of clinical function scores between the two groups of patients before surgery and at the last follow-up

组别Group	例数Case number	OKS		AKSS-O		AKSS-F		VAS		ROM(°)
组别Group	例数Case number	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up
生物型组Cementless group	32	21.0(18.0，25.0)	39.0(36.0, 41.7)	55.5(48.3, 71.5)	92.0(88.0，94.0)	67.5(55.0，75.0)	90.0(90.0，95.0)	5.5(5.0，6.0)	2.0(2.0，2.0)	95.0(90.0，110.0)	115.0(106.3，120.0)
骨水泥组Cenmented group	32	25.00(19.3，28.0)	40.0(38.0, 42.0)	56.5(53.0，70.0)	92.0(86.0，93.8)	67.5(60.0，75.0)	90.0(90.0，95.0)	6.0(4.3，6.0)	2.0(2.0，3.0)	100.0(90.0，115.0)	115.0(101.3，120.0)
Z值		－1.602	－1.174	－0.558	－1.122	－0.034	－0.621	－0.063	－1.113	－1.088	－1.152
P值		>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05

表2 两组患者术前及末次随访时临床功能评分比较[M(P₂₅，P₇₅)]

Table 2 Comparison of clinical function scores between the two groups of patients before surgery and at the last follow-up

组别Group	例数Case number	OKS		AKSS-O		AKSS-F		VAS		ROM(°)
组别Group	例数Case number	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up	术前Before surgery	末次随访Last follow-up
生物型组Cementless group	32	21.0(18.0，25.0)	39.0(36.0, 41.7)	55.5(48.3, 71.5)	92.0(88.0，94.0)	67.5(55.0，75.0)	90.0(90.0，95.0)	5.5(5.0，6.0)	2.0(2.0，2.0)	95.0(90.0，110.0)	115.0(106.3，120.0)
骨水泥组Cenmented group	32	25.00(19.3，28.0)	40.0(38.0, 42.0)	56.5(53.0，70.0)	92.0(86.0，93.8)	67.5(60.0，75.0)	90.0(90.0，95.0)	6.0(4.3，6.0)	2.0(2.0，3.0)	100.0(90.0，115.0)	115.0(101.3，120.0)
Z值		－1.602	－1.174	－0.558	－1.122	－0.034	－0.621	－0.063	－1.113	－1.088	－1.152
P值		>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05	>0.05

图3 生物组1例右胫骨平台骨折X线影像。图A为UKA(单髁膝关节置换)术中右膝正侧位X线透视，示右膝关节内侧单间室退变，外侧间室及髌股关节尚可；图B为UKA术中右膝正侧位X线透视，示假体位置良好；图C为术后6周右膝正侧位X线片，示右侧胫骨平台骨折伴移位，假体下沉；图D为切开复位钢板内固定术后6个月右膝正侧位X线片，示骨折线模糊，有连续性骨痂通过骨折线，已经达到临床愈合

Figure 3 X-ray images of a right tibial plateau fracture case in the cementless group. A and B are intraoperative fluoroscopic anterior-posterior and lateral views of the right knee during the UKA, A shows medial unicompartmental degeneration of the right knee, with the lateral compartment and patellofemoral joint still intact, B shows a well positioned prosthesis; C is anterior-posterior and lateral views of right knee at postoperative six weeks, showing a right tibial plateau fracture with displacement and sinking prosthesis; D is anterior-posterior and lateral views of right knee at postoperative six months following incision and reduction with internal plate fixation, showing a blurred fracture line with continuous bone scab through the fracture line, which has reached clinical healing

[1]	Saweeres ES. The Oxford medial unicompartmental knee replacement using a minimally-invasive approach[J]. J Bone Joint Surg Br, 2006, 88(8): 1116－1117；authorreply1117.
[2]	Graves SE, Davidson D, Ingerson L, et al. The Australian orthopaedic association national joint replacement registry[J]. Med J Aust, 2004, 180(S5): S31－S34.
[3]	Kendrick BJ, Longino D, Pandit H, et al. Polyethylene wear in Oxford unicompartmental knee replacement: a retrieval study of 47 bearings[J]. J Bone Joint Surg Br, 2010, 92(3): 367－373.
[4]	Goodfellow J, O'Connor J, Pandit H, et al. Design and biomechanics of the Oxford knee[M/OL]// Goodfellow J. Unicompartmental arthroplasty with the Oxford Knee.2nd edition.Oxford: Oxford University Press, 2015. DOI: 10.23912/978-1-910158-45-6-1517
[5]	Liddle AD, Pandit H, O'Brien S, et al. Cementless fixation in Oxford unicompartmental knee replacement: a multicentre study of 1000 knees[J]. Bone Joint J, 2013, 95－B(2): 181－187.
[6]	Gulati A, Chau R, Simpson DJ, et al. Influence of component alignment on outcome for unicompartmental knee replacement[J]. Knee, 2009, 16(3): 196－199.
[7]	Kendrick BJ, Kaptein BL, Valstar ER, et al. Cemented versus cementless Oxford unicompartmental knee arthroplasty using radiostereometric analysis: a randomised controlled trial[J]. Bone Joint J, 2015, 97－B(2): 185－191.
[8]	Pandit H, Jenkins C, Beard DJ, et al. Cementless Oxford unicompartmental knee replacement shows reduced radiolucency at one year[J]. J Bone Joint Surg Br, 2009, 91(2): 185－189.
[9]	Campi S, Pandit H, Hooper G, et al. Ten-year survival and seven-year functional results of cementless Oxford unicompartmental knee replacement: a prospective consecutive series of our first 1000 cases[J]. Knee, 2018, 25(6): 1231－1237.
[10]	Stempin R, Stempin K, Kaczmarek W. Medium-term outcome of cementless, mobile-bearing, unicompartmental knee arthroplasty[J/OL]. Ann Transl Med, 2019, 7(3): 41. DOI: 10.21037/atm.2018.12.50.
[11]	Kerens B, Schotanus MGM, Boonen B, et al. Cementless versus cemented Oxford unicompartmental knee arthroplasty: early results of a non-designer user group[J]. Knee Surg Sports Traumatol Arthrosc, 2017, 25(3): 703－709.
[12]	Kim KT, Lee S, Kim JH, et al. The survivorship and clinical results of minimally invasive unicompartmental knee arthroplasty at 10-year follow-up[J]. Clin Orthop Surg, 2015, 7(2): 199－206.
[13]	Tomlinson M, Harrison M. The New Zealand Joint Registry: report of 11-year data for ankle arthroplasty[J]. Foot Ankle Clin, 2012, 17(4): 719－723.
[14]	Seeger JB, Haas D, Jäger S, et al. Extended sagittal saw cut significantly reduces fracture load in cementless unicompartmental knee arthroplasty compared to cemented tibia plateaus: an experimental cadaver study[J]. Knee Surg Sports Traumatol Arthrosc, 2012, 20(6): 1087－1091.
[15]	Vaidya SV, Ranawat CS, Aroojis A, et al. Anthropometric measurements to design total knee prostheses for the Indian population[J]. J Arthroplasty, 2000, 15(1): 79－85.

[1]	许正文, 李振, 侯振扬, 苏长征, 朱彪. 富血小板血浆联合植骨治疗早期非创伤性股骨头坏死[J]. 中华关节外科杂志(电子版), 2023, 17(06): 773-779.
[2]	邓华梅, 袁札根, 曾德荣, 潘珊珊, 张葆青, 欧爱华, 曹学伟. 全膝关节置换术中气压止血带应用效果与影响因素分析[J]. 中华关节外科杂志(电子版), 2023, 17(06): 788-794.
[3]	张思平, 刘伟, 马鹏程. 全膝关节置换术后下肢轻度内翻对线对疗效的影响[J]. 中华关节外科杂志(电子版), 2023, 17(06): 808-817.
[4]	闫文, 谢兴文, 顾玉彪, 雷宁波, 马成, 于文霞, 高亚雄, 张磊. 微小RNA与全膝关节置换术后深静脉血栓的研究进展[J]. 中华关节外科杂志(电子版), 2023, 17(06): 842-846.
[5]	王宏宇. 固定与活动平台假体在全膝关节置换术中的应用价值[J]. 中华关节外科杂志(电子版), 2023, 17(06): 871-876.
[6]	李善武, 叶永杰, 王兵, 王子呓, 银毅, 孙官军, 张大刚. 胫骨高位截骨与单髁置换的早期疗效比较[J]. 中华关节外科杂志(电子版), 2023, 17(06): 882-888.
[7]	李辉, 吴奇, 张子琦, 张晗, 王仿, 许鹏. 日间全膝关节置换术早期疗效及标准化流程探索[J]. 中华关节外科杂志(电子版), 2023, 17(06): 889-892.
[8]	刘伦, 王云鹭, 李锡勇, 韩鹏飞, 张鹏, 李晓东. 机器人辅助膝关节单髁置换术的研究进展[J]. 中华关节外科杂志(电子版), 2023, 17(05): 715-721.
[9]	王桂冠, 徐杰. 运动学对线在全膝关节置换术中的研究进展[J]. 中华关节外科杂志(电子版), 2023, 17(05): 726-731.
[10]	杨依琴, 何敏仪, 杜桂菊, 刘欣, 詹文英. 膝关节置换术后康复应用基于保护动机理论的健康教育[J]. 中华关节外科杂志(电子版), 2023, 17(05): 741-746.
[11]	姚轶超, 张麒, 滕海茂, 黄攀, 吴雷涛, 韩哲. 膝关节置换术后恐动症与康复效果及社会支持的相关性[J]. 中华关节外科杂志(电子版), 2023, 17(05): 613-618.
[12]	张中斌, 付琨朋, 朱凯, 张玉, 李华. 胫骨高位截骨术与富血小板血浆治疗膝骨关节炎的疗效[J]. 中华关节外科杂志(电子版), 2023, 17(05): 633-641.
[13]	陈垚, 徐伯群, 高志慧. 改良式中间上入路根治术治疗甲状腺癌的有效性安全性研究[J]. 中华普外科手术学杂志(电子版), 2023, 17(06): 619-622.
[14]	张海涛, 康婵娟, 翟静洁. 胰管支架置入治疗急性胆源性胰腺炎效果观察[J]. 中华普外科手术学杂志(电子版), 2023, 17(06): 654-657.
[15]	王峰杰, 王礼光, 廖珊, 刘颖, 符荣党, 陈焕伟. 腹腔镜右半肝切除术治疗肝癌的安全性与疗效[J]. 中华肝脏外科手术学电子杂志, 2023, 12(05): 517-522.

阅读次数

全文

摘要

选择文件类型/文献管理软件名称

选择包含的内容

Comparison of early efficacy between cementless and cemented unicompartmental knee replacements

模态框（Modal）标题

选择文件类型/文献管理软件名称

选择包含的内容

Comparison of early efficacy between cementless and cemented unicompartmental knee replacements