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]	任俊筱, 浦路桥, 王志豪, 施洪鑫, 刘爱峰, 齐保闯, 徐永清, 李川. 机器人辅助全膝关节置换术的临床疗效对照研究[J/OL]. 中华关节外科杂志(电子版), 2024, 18(04): 469-476.
[2]	李志文, 李远志, 李华, 方志远. 糖皮质激素治疗膝骨关节炎疗效的网状Meta分析[J/OL]. 中华关节外科杂志(电子版), 2024, 18(04): 484-496.
[3]	许亚龙, 巩栋, 陈晓涛. 超前镇痛在全膝关节置换术中的研究进展[J/OL]. 中华关节外科杂志(电子版), 2024, 18(04): 517-523.
[4]	庄若语, 杭明辉, 李文华, 张霆, 侯炜. 膝骨关节炎半定量磁共振评分研究进展[J/OL]. 中华关节外科杂志(电子版), 2024, 18(04): 545-552.
[5]	丁莹莹, 宋恺, 金姬延, 田华. 机器人辅助膝髋关节置换术后精细化临床护理[J/OL]. 中华关节外科杂志(电子版), 2024, 18(04): 553-557.
[6]	王冰, 孙海宁, 于秀淳, 周珂, 翟凯, 苗族康. 膝骨关节炎的活动衬垫型单髁置换疗效与假体生存率[J/OL]. 中华关节外科杂志(电子版), 2024, 18(03): 337-345.
[7]	张江礼, 刘金辉, 潘西庆, 刘光源, 范虓. 全膝关节置换应用智能辅助手术导航系统治疗膝骨关节炎[J/OL]. 中华关节外科杂志(电子版), 2024, 18(03): 346-351.
[8]	杨士慷, 曹光磊. 膝骨关节炎三种术式患者满意度的术前影响因素[J/OL]. 中华关节外科杂志(电子版), 2024, 18(03): 390-397.
[9]	刘正宇, 刘春风, 王振. 改良后外侧入路半髋置换治疗股骨颈骨折的早期疗效[J/OL]. 中华关节外科杂志(电子版), 2024, 18(03): 409-413.
[10]	王啸, 李一凡, 沈素红, 曹国瑞, 史小涛, 袁彦浩, 谭红略. 全膝关节置换术后早期下肢深静脉血栓形成的时空规律[J/OL]. 中华关节外科杂志(电子版), 2024, 18(03): 414-420.
[11]	卢芳连, 汤莉, 何河北, 李建云, 欧栓机, 陈燕, 陈娇妹. 责任护士主导的疼痛管理在膝关节置换术后的应用[J/OL]. 中华关节外科杂志(电子版), 2024, 18(02): 285-289.
[12]	中华医学会骨科学分会关节外科学组, 解放军总医院第四医学中心骨科医学部, 国家骨科与运动康复临床医学研究中心. 中国膝骨关节炎非手术治疗专家共识(2023年版)[J/OL]. 中华关节外科杂志(电子版), 2024, 18(02): 151-159.
[13]	朴成林, 蓝炘, 司振铎, 李强, 冯健, 安峰铎, 冷建军. 胰十二指肠切除联合肝切除术疗效分析：附5例报告（附视频）[J/OL]. 中华普通外科学文献(电子版), 2024, 18(05): 363-367.
[14]	李华志, 曹广, 刘殿刚, 张雅静. 不同入路下行肝切除术治疗原发性肝细胞癌的临床对比[J/OL]. 中华普外科手术学杂志(电子版), 2025, 19(01): 52-55.
[15]	许月芳, 刘旺, 曾妙甜, 郭宇姝. 多粘菌素B和多粘菌素E治疗外科多重耐药菌感染临床疗效及安全性分析[J/OL]. 中华普外科手术学杂志(电子版), 2024, 18(06): 700-703.

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