单髁置换治疗重度膝内侧间室骨关节炎合并中度外侧间室骨关节炎的临床获益

doi:10.12307/2026.619

摘要/Abstract

摘要：

文题释义：

单髁置换：即膝关节单髁表面置换，是膝关节炎终末期治疗手段之一，分为内侧间室单髁置换及外侧间室单髁置换，原理为用人工材料替代破损的软骨及半月板。因该术式尽可能保留自身骨量及韧带，患者术后早期疗效显著，近年来备受关注。
K-L分级：即膝骨关节炎Kellgren-Lawrence分级，在X射线片上对膝骨关节炎病情进行分级，分为0-4级。

摘要
背景：对于膝内侧间室重度骨关节炎合并有外侧间室中度骨关节炎的患者，单纯接受内侧单髁置换治疗是否能得到满意临床获益尚且存在争议。
目的：对比分析单髁置换与全膝关节置换在合并膝关节异质性退变(内侧间室Kellgren-Lawrence Ⅲ-Ⅳ级/外侧间室Ⅱ级)患者中临床疗效的差异。
方法：选择术前膝关节X射线片显示为重度内侧间室骨关节炎合并轻中度外侧间室骨关节炎的膝关节置换患者，按照术式不同分为单髁置换组和全膝关节置换组，按照1∶1的配对，最终两组各纳入50例患者。收集术后3个月、6个月、1年和2年的西安大略与麦克马斯特大学(WOMAC)骨关节炎指数、美国膝关节协会评分、关节遗忘评分以及术后步态参数及并发症情况，并将相关数据进行统计学分析，对比两组术后疗效的差异。
结果与结论：①术后3个月、6个月及1年时单髁置换组美国膝关节协会评分、WOMAC骨关节炎指数均优于全膝关节置换组(P < 0.05)；术后2年，两组美国膝关节协会评分、WOMAC骨关节炎指数相比差异无显著性意义(P > 0.05)；②对于关节遗忘评分，术后3个月两组相比差异无显著性意义(P > 0.05)，术后6个月、1年、2年单髁置换组高于全膝关节置换组(P < 0.05)；③术后1年时，单髁置换组步速、步幅优于全膝关节置换组(P < 0.05)，两组术后步频参数相比差异无显著性意义(P > 0.05)；④术后2年内两组均无并发症发生；⑤随访证实术后2年在膝关节内侧间室重度骨关节炎(Kellgren-LawrenceⅢ-Ⅳ级)合并外侧间室中度退变(Kellgren-LawrenceⅡ级)患者中，单髁置换的临床疗效与全膝置换具有等效性，且在术后1年内单髁置换生物力学优势显著；在随访期间，未发现患者外侧间室骨关节炎情况明显进展(Kellgren-Lawrence分级增加)，但有待长期观察；医生决策前应建立多维度评估框架(包括患者年龄、运动负荷预期、术者单髁置换手术量等)，同时需向患者充分告知外侧间室的进展风险，综合评估决定是否行单髁置换治疗。

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

关键词: 膝骨关节炎, 外侧间室, 单髁置换, 全膝关节置换, 膝关节功能, 步态, 适应证, 回顾性研究

Abstract: BACKGROUND: In patients with severe medial compartment osteoarthritis of the knee combined with moderate lateral compartment osteoarthritis, it is controversial whether medial monondylar replacement alone can achieve satisfactory clinical benefit.
OBJECTIVE: To compare and analyze the difference in clinical outcomes of unicompartmental knee arthroplasty and total knee arthroplasty in patients with heterogeneous degenerative changes of the knee (medial compartment Kellgren-Lawrence grade III-IV combined with lateral compartment Kellgren-Lawrence grade II).
METHODS: Knee arthroplasty patients with severe medial ventricular osteoarthritis combined with mild and moderate lateral ventricular osteoarthritis shown by preoperative knee X-ray were selected and divided into unicompartmental knee arthroplasty group and total knee arthroplasty group according to different operation methods, and 50 patients were included in each group according to 1:1 pairing. Western Ontario and McMaster University Osteoarthritis Index (WOMAC), American Knee Association Score, joint amnesia score, postoperative gait parameters, and complications were collected at 3, 6 months, 1 and 2 years after surgery, and the relevant data were statistically analyzed to compare the differences in postoperative efficacy between the two groups.
RESULTS AND CONCLUSION: (1) The American Knee Association Score and WOMAC scores of the unicompartmental knee arthroplasty group were better than those of the total knee arthroplasty group at 3, 6 months and 1 year after surgery (P < 0.05). Two years after surgery, American Knee Association Score and WOMAC score were not significantly different between two groups (P > 0.05). (2) There was no significant difference in joint amnesia score between the two groups 3 months after operation (P > 0.05). The joint amnesia score was higher in the unicompartmental knee arthroplasty group than that in the total knee arthroplasty group at 6 months, 1 year and 2 years after surgery (P < 0.05). (3) At 1 year after surgery, step speed and step length were better in the unicompartmental knee arthroplasty group than those in the total knee arthroplasty group (P < 0.05). No statistically significant differences in step frequency were detected between the two groups (P > 0.05). (4) No complications occurred in both groups within 2 years after operation. (5) Follow-up showed that unicompartmental knee arthroplasty was clinically equivalent to total knee arthroplasty in patients with severe medial compartment osteoarthritis (Kellgren-Lawrence III-IV) combined with moderate lateral compartment degeneration (Kellgren-Lawrence II) 2 years after surgery. Unicompartmental knee arthroplasty had a significant biomechanical advantage within 1 year after surgery. No significant progression of lateral interventricular osteoarthritis was observed during follow-up (Kellgren-Lawrence grade increase), but further long-term observation is needed. Before making decisions, doctors should establish a multi-dimensional evaluation framework (including patient age, exercise load expectation, unicompartmental knee arthroplasty operation amount of the surgeon, etc.), and fully inform patients of the risk of lateral compartment progression, and decide whether to perform unicompartmental knee arthroplasty after comprehensive assessment.

Key words: knee osteoarthritis, lateral intercompartment, unicompartmental knee arthroplasty, total knee arthroplasty, knee joint function, gait, indication, retrospective study

中图分类号:

崔鹏飞, 文章坤, 陈封江, 王振, 王昌耀. 单髁置换治疗重度膝内侧间室骨关节炎合并中度外侧间室骨关节炎的临床获益[J]. 中国组织工程研究, 2026, 30(21): 5452-5459.

Cui Pengfei, Wen Zhangkun, Chen Fengjiang, Wang Zhen, Wang Changyao. Unicompartmental knee arthroplasty for severe medial compartment osteoarthritis with moderate lateral involvement: clinical outcomes[J]. Chinese Journal of Tissue Engineering Research, 2026, 30(21): 5452-5459.

图/表（结果） 9

2.1 参与者数量分析 通过倾向性评分匹配，按照1∶1比例，将符合入组标准的患者进行匹配，最终两组各纳入50例(50膝)。术后线上随访全部完成；线下步态随访因地域限制及人员流动，仅完成术后1年的随访。
所有患者均为初次置换且随访期间对侧下肢关节未进行其他手术治疗。单髁置换组随访时间24-29个月，平均(25.0±1.2)个月；全膝关节置换组随访时间24-29个月，平均(26.0±1.7)个月。
2.2 试验流程图 见图1。

2.3 基线资料对比 两组患者术前体质量指数、性别、年龄对比差异无显著性意义(P > 0.05)，见表2。

2.4 两组结果数据对比
2.4.1 两组WOMAC骨关节炎指数对比两组WOMAC骨关节炎指数采用Mann-Whitney U检验，用M(Q1，Q3)表示。结果显示在术后3个月、6个月、1年，单髁置换组WOMAC骨关节炎指数明显小于全膝关节置换组，差异有显著性意义(P < 0.05)；而在术后2年，两组差异无显著性意义(P > 0.05)，见表3，图2。

2.4.2 两组AKS评分对比单髁置换组与全膝关节置换组AKS评分数据采用Mann-Whitney U检验，用M(Q1，Q3)表示。结果显示在术后3个月、术后6个月、术后1年，单髁置换组AKS评分显著高于全膝关节置换组，差异有显著性意义(P < 0.05)，而在术后2年，单髁置换组与全膝关节置换组评分差异无显著性意义(P > 0.05)，见表4，图3。

2.4.3 两组关节遗忘评分对比两组关节遗忘评分采用Mann-Whitney U检验，用M(Q1，Q3)表示。结果显示，在术后3个月，两组关节遗忘评分相比差异无显著性意义(P > 0.05)，而在术后6个月、1年、2年，单髁置换组评分高于全膝关节置换组，差异有显著性意义(P < 0.05)，见表5，图4。

2.4.4 两组步态分析指标对比单髁置换组与全膝关节置换组术后1年步态分析示单髁置换组步速、步幅优于全膝关节置换组，差异有显著性意义(P < 0.05)，而两组步频差异无显著性意义(P > 0.05)，见表6。

2.5 典型病例影像学资料 在随访期间，未发现患者外侧间室骨关节炎明显进展(Kellgren-Lawrence分级增加)，见图5，6。
2.6 并发症 在此次研究中，两组患者随访过程中均未发生垫片脱位、感染、伤口不愈合、深静脉血栓(监测D-二聚体指标，若指标升高则加做下肢血管超声检查)等并发症。
2.7 植入物与宿主的生物相容性 两组患者均未出现植入物周围感染、过敏反应、免疫反应及排斥反应。

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引言

材料方法

1.1 设计 回顾性分析。
1.2 时间及地点 试验于2022年10月至2024年10月在青岛大学附属医院西海岸院区完成。

1.3 材料 相关植入物材料信息见表1。

1.4 对象 采用回顾性分析的方式，选择2021年6月至2022年8月因膝骨关节炎于青岛大学附属医院西海岸院区行膝关节置换手术且符合纳入标准的患者，应用倾向性评分匹配法平衡组间基线资料及术前评分，按照1∶1的比例，最终全膝关节置换组与单髁置换组各纳入50例患者(50膝)。
纳入标准：①术前无膝关节外侧间室症状；②术前X射线片示膝关节内侧间室骨关节炎K-L分级Ⅲ、Ⅳ级，外侧间室K-L分级Ⅱ级；术前MRI显示外侧间室软骨无明显缺损；③膝关节活动度≥90°，伸直受限< 15°，内翻畸形≤10°或者外翻畸形≤15°；④前交叉韧带完好。
排除标准：①合并有累及全膝的疾病，如类风湿性关节炎等；②身体基础状态差，术前有严重糖尿病、心脏病等；③无法接受长期随访。
此次研究方案经青岛大学附属医院医学伦理委员会批准(批号：QYFYWZLL29238，审批时间：2024年10月)，所有患者均知情同意并自愿参与此次研究。
1.5 方法
1.5.1 手术方法两组手术均由同一医师操作。
单髁置换组：均采用第3代Oxford活动垫片单髁假体。取患侧膝关节内侧旁正中切口，暴露内侧间室，同时尽可能暴露髁间，非必须不显露髌上囊。去除相应部位骨赘，切除内侧半月板，用胫骨截骨导向器及摆锯切除内侧胫骨平台并匹配相应的胫骨假体。用开口锥在股骨上开髓，插入髓内定位杆，插入股骨钻孔导向器，使股骨钻孔导向器与髓内定位杆相平行，打孔后通过股骨截骨模块切除股骨后髁。用球形研磨器对股骨内侧髁进行研磨，修整切割齿边缘以外的骨组织。应用测厚器平衡屈伸间隙。安装相应试模后检查膝关节活动度良好，关节周围罗哌卡因浸润镇痛后冲洗关节腔，调制骨水泥，安放与试样同型号的胫骨假体、股骨假体及半月板衬垫，待骨水泥冷固后缝合包扎。
全膝关节置换组：均采用威高国产后稳定型全膝假体。取患膝关节前正中纵行切口，髌旁内侧入路切开关节囊，显露膝关节，切除关节内增生滑膜组织及前交叉韧带，松解内侧副韧带止点，凿除髁间窝骨赘，髓内定位后，外翻截除股骨远端，后行四合一截骨板外旋截骨；胫骨髓外定位，沿胫骨外侧平台下后倾截骨，试模合适后修整髌骨，胫骨托截骨板钻孔塑形胫骨平台，冲洗，关节周围罗哌卡因浸润镇痛，安装相应假体，并骨水泥固定，待骨水泥凝固后冲洗，放引流管1根，逐层缝合包扎。
1.5.2 术后处理全膝关节置换组患者术后携带1根引流管，并于次日拔除；单髁置换组无引流管。所有患者均于术后第1天开始行CPM机器锻炼及踝泵运动锻炼。术后2 d两组均给予口服氨酚双氢可待因片及静滴氟比洛芬酯进行有效镇痛，此后无必要不继续使用止痛药物。
1.6 主要观察指标 两组均于术后3个月、6个月、1年和2年通过电话随访获得西安大略与麦克马斯特大学(the Western Ontario and McMaster Universities，WOMAC)骨关节炎指数、关节遗忘评分、美国膝关节协会(the American knee society，AKS)评分及有无并发症。术后1年时线下通过步态分析仪器获取相关步态参数(步幅、步频、步速)。
WOMAC骨关节炎指数每项评分采用0-4级评分，总分96分，由3部分组成：疼痛评分(最高20分)、关节僵硬评分(最高8分)及关节功能评分(最高68分)。分数越低表示膝关节症状及功能越好。
AKS评分分为膝关节评分(疼痛、活动度和稳定性)和功能评分(行走能力等)，全面评估膝关节状态，总分200分，分数越高表明术后恢复越好[5]。
关节遗忘评分由12个问题组成，采用5分法进行评估，12个问题分数相加并线性转换为0-100分，其分值越高反映患者忘记人工关节的程度越好[6]。
步态分析仪采用三维步态分析系统 A7-2(Gait Analysis System A7-2，国产一康医疗设备实业有限公司)。使用方法：将传感器校准后置于患者双侧大腿、双侧小腿及双侧脚掌，嘱患者在测试前先于测量道上按照日常状态适应性行走，调整速度至舒适，正式测量前给予患者适当休息时间。正式测量时受试者需目视前方，无任何辅助设备、排除周围其他干扰，测量距离为10 m，测量3-5次，间隔5 min休息时间。去除同时间段测量数据相差较大的数据，剩余数据取其平均值作为此次测量数据结果。
为确保线上随访数据的准确性与可靠性，此次研究建立以下质量控制体系：①数据真实性双重验证机制——由2名专业医师采用双盲核查法，分别于独立时间点(间隔≥48 h)通过标准化问卷对患者及其主要照护者进行电话随访。数据采集遵循以下原则：2次调查结果完全一致者予以采纳；存在分歧时启动复核程序，由第3位专业医师介入，经三方沟通达成共识后确认最终数据。②专业评估指标的客观化处理——针对膝关节活动度等需专业判读的指标，实施分级验证方案：优先获取患者患肢最大屈伸角度的动态影像资料(尽量包含量角器参照)，由专业医师采用双盲法测量(取均值)；若无影像证据支持，则要求患者与家属分别进行角度估算，仅采纳2次评估差值≤5°的数据。
1.7 统计学分析 采用SPSS 27.0软件进行统计学分析。计量资料若符合正态分布，则以x±s表示，采用独立t检验进行组间比较；若不符合正态分布，则用M(Q1，Q3)表示，进行Mann-Whitney U检验；定类变量则采用Pearson卡方检验。以P < 0.05为差异有显著性意义，检验水准取双侧α=0.05。文章统计学方法已经由青岛大学附属医院生物统计学专家审核。

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

讨论

膝关节置换术作为终末期骨关节炎的终极治疗手段，其术式选择需遵循精准化治疗原则。单髁置换术在严格筛选适应证患者中展现出显著优势[7]：术中出血更少[8-11]，患者术后疼痛更轻[12-15]，患者满意度更高[16]，术后步态更接近正常[17-18]。但对于合并外侧间室中度(K-L分级Ⅱ级)骨关节炎的患者行单髁置换治疗是否合适尚无明确定论。
自1989年KOZINN等[19]首次系统提出单髁置换的手术适应证以来，单髁置换适应证逐渐扩大。HANSEN等[20]及SIMAN等[21]的研究表明年龄可能不是单髁置换的限制。SENG等[22]研究表明，行单髁置换治疗患者术前内翻畸形程度超出单髁置换标准也可能使患者从中受益。KUYUCU等[23]的一项研究中随访了57例体质量指数> 30 kg/m2的患者，最终他们认为对于肥胖患者单髁置换也是可行的手术方式。SEARLE等[4]对15年前行内侧单髁置换治疗患者的外侧间室骨关节炎进展情况进行了调查统计，结果证明单髁置换术后15年内外侧间室骨关节炎进展为中重度的概率实际并不高(大概4.9%)。WALDSTEIN
等[24]通过研究证明外侧骨赘与外侧软骨退变之间并无明确联系。而在新技术、新材料蓬勃发展的今天，单髁置换同样面临着适应证窄而意向人群逐渐增多的矛盾问题。此外，有研究表明外科医生的单髁置换手术量与单髁置换术后预后有一定联系，外科医生可以通过增加一定程度的单髁置换手术量来使患者获得更多的预期寿命[25-26]，这同样迎合了单髁置换潮流趋势。
此次研究通过多维度功能评估证实，对于术前影像学显示外侧间室骨关节炎但无典型症状的患者，内侧单髁关节置换术后在早期功能恢复方面展现出显著优势，其远期疗效与全膝关节置换术具有可比性，这一发现为拓展单髁置换适应证提供了重要循证依据。
在疼痛管理与功能恢复方面，单髁置换组术后1年内的优势尤为突出：其WOMAC疼痛评分、僵硬评分较全膝关节置换组差异明显，AKS关节评分提升明显(P < 0.05)。这种早期优势可能与单髁置换保留膝关节本体感觉及生物力学完整性密切相关[27-29]。值得注意的是，术后2年随访显示两组功能评分趋于一致(两组WOMAC骨关节炎总分P=0.362)，提示当外侧间室病变尚未进展至临床症状阶段时，单髁置换的力学重建效果可维持长期稳定。
步态分析进一步支持单髁置换的生理重建优势。单髁置换组术后1年步幅显著高于全膝关节置换组(P=0.012)，这可能与术中保留前交叉韧带维持膝关节运动学特性相关[30-31]。全膝关节置换术后患者由于前交叉韧带的缺失，股四头肌力量会有一定程度减弱[32-33]，这也有可能是步态差异的原因之一。两组患者在步频数据上并无明显统计学差异(P > 0.05)，这可能与单髁置换组患者更优异的步幅与步速有关[34]。
特别需要关注的是，步速作为老年患者生活质量的重要预测指标[35]，单髁置换组达到(0.84±0.07) m/s，
较全膝关节置换组(0.81±0.05) m/s提升明显(P=0.019)，这一差异可能对患者远期生活能力产生重要影响。
在假体适应方面，关节遗忘评分动态变化揭示了单髁置换的独特价值。术后6个月单髁置换组评分显著高于全膝关节置换组(P=0.037)，且优势持续至2年随访。这种现象可能源于单髁置换对关节本体感觉的保留，使患者更易重建运动神经控制模
式[36-38]。
需要特别指出的是，此次研究纳入的病例均经过严格筛选：MRI证实外侧间室软骨厚度尚可，且Kellgren-Lawrence分级为2级。对于更严重的结构性病变(如软骨大面积缺损)，单髁置换的适用性仍需谨慎评估。膝关节置换术后早期并发症有感染、贫血、深静脉血栓等，中远期并发症包括衬垫脱位、假体松动等，尽管两组均未观察到假体松动等并发症，但单髁置换特有的衬垫脱位风险要求术者必须掌握精准的截骨技术，这可能需要医生花费一定时间成本去达成[39-40]。
此次研究的局限性包括：①样本量较小(每组50例)，可能影响统计效力；②随访时间较短(最长2年)，需延长观察期评估远期翻修率；③依赖传统Kellgren-Lawrence分级系统，未来可采用三维软骨定量分析提升评估精度。建议开展多中心随机对照试验，建立基于生物标志物与影像组学的单髁置换适应证扩展标准。
结论：此次研究表明，对于内侧间室重度骨关节炎合并外侧间室Kellgren-LawrenceⅡ级病变的特殊病例，单髁置换在术后早期康复阶段(≤1年)具有显著的临床优势，而术后2年数据显示两组功能评分趋同，提示单髁置换在中远期可达到与全膝关节置换相当的关节功能重建效果，但有待于更大范围、更长时间的随访调查研究。具体手术方式的选择应根据患者具体情况及手术医生自身优势综合考虑。

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