【专题文献】之膝外翻全膝TKA--全膝置换术中使用十字形保留型假体治疗严重外翻畸形的结果
Esa Koskinen c,?, Ville Remes b, Pekka Paavolainen a, Arsi Harilainen a, Jerker Sandelin a, Kaj Tallroth a,
Jyrki Kettunen c, Pekka Ylinen a
全膝置换术中使用十字形保留型假体治疗严重外翻畸形的结果----对48名患者平均9年的随访研究
a b s t r a c t 摘要
The objectives of the present study were to find out the results and the factors affecting survival after primary knee arthroplasty with a cruciate-retaining prosthesis in severe valgus deformity. Forty-eight patients (52 knees) participated in the current follow-up study. All patients were followed at least 5 years or to first revision. Mean follow-up time was 9 years (range, 1 to 17 years).The Kaplan–Meier analysis revealed 79% (95% CI 68% to 91%) survival rate with revision for any reason and 81% (95% CI 70% to 93%) survival rate with revision for instability as an endpoint at 10 years. Preoperatively TFA was 23° (range, 15°–51°) in valgus and 7° (range, 21° valgus–4° varus) in valgus postoperatively.
本研究旨在找出那些严重外翻畸形而经应用一种十字形保留的假体行主要的膝关节成形术后影响其生存的结果和因素。 48名患者(52个膝关节)参加了当前随访研究。所有患者被随访了至少5年或到第一次翻修。平均随访时间是9年(范围, 1到17年)。Kaplan–Meier分析显示了79 %(95%可信区间68%到91%)以任何原因翻修的生存率和81% (95%可信区间70%到93%)因不稳、以10年为终点而翻修的生存率。术前的胫股交角是外翻23° (范围, 15°-51°)和术后外翻7° (范围, 21°外翻-4°内翻)。
Of the 14 re-operated patients, eight were revised because of progressive postoperative medial collateral ligament instability. All re-operations were performed during the first 4 years of the follow-up. The mean TFA was 15.5° valgus postoperatively for those eight and the odds ratio for a revision was 2 (95% CI 1–3, p=0.025) when compared to the rest of the study population. The residual valgus deformity increases the risk of re-operation and it should be avoided. If proper soft-tissue balance cannot be achieved or there is no functional medial collateral ligament present more constrained implants should be used. In selected cases where both bony correction and ligament balancing have properly been achieved the use of a cruciate-retaining type of prosthesis is justified.
由于进行性的术后内侧副韧带不稳, 14名患者重新手术,八名被校正了。所有再手术者都在随访的前4年期间施行了。与研究的其余人群相比,那8人的术后平均胫股交角是15.5°外翻而被修正的可能性比率为2 (95% 可信区间1-3, p=0.025)。残余的外翻畸形增加了再手术的风险,并且应该避免它。如果适当的软组织平衡不能被实现或内侧副韧带没有功能,目前更有约束力的植入物应该使用。在选择的病例,通过使用一个十字形保留类型的假体来获得骨的矫正和韧带的平衡,这已被证明是合理的。
1. Introduction 介绍
In an osteoarthritic knee varus deformity is more common than valgus. Apart from primary osteoarthritis (OA), valgus deformity may be secondary to rheumatoid arthritis, polio, renal osteodystrophy, rickets, or a consequence of an intra-articular fracture.
膝关节骨关节炎内翻畸形比外翻畸形更普遍。除主要骨关节炎(OA)之外,外翻畸形对于风湿性关节炎、小儿麻痹症、肾脏骨营养不良、软骨病或者关节内骨折的后果,也许是次要的。
Primary total knee arthroplasty (TKA) in patients with a severe valgus deformity may be challenging since the bony anatomy differs fromthemore common varus knee. The valgus knee may have complex angular deformities with varying degrees of flexion and external rotation.
因为在骨的解剖学上不同于内翻膝,存在严重外翻畸形的患者,接受主要的全膝关节置换术(TKA)也许富挑战性。外翻膝也许有复杂成角畸形伴以不同程度屈曲和向外旋转。
Typically the tibia is in external rotation, the lateral femoral condyle is hypoplastic, and the patella may be subluxated or dislocated. There is often bone loss on the lateral femoral condyle (Fig. 1). One study has shown a greater risk of component malposition [1].
典型的是胫骨是向外旋转,侧向股骨髁发育不全的话,髌骨也许就会半脱位或全脱位。常会有侧向股骨髁的骨丢失(图 1). 一项研究显示了组件错位的一种更加巨大的风险。
Results of TKA for severe valgus deformity with a cruciateretaining (CR) or posterior stabilized (PS) implant have been published [1–8]. However, there are only a few studies that report
long-term results [3,6]. Miyasaka et al. [6] published series of 60 valgus knees treated with a CR model. They had a 91% survival rate after an average follow-up time of 13 years. In their study, the preoperative tibiofemoral angle (TFA) averaged 17° in valgus. The survival rate was good, although the rate of postoperative instabilitywas as high as 24% because of extensive lateral ligament release.
对严重外翻畸形施行TKA时应用一个十字形保留(CR)或后部被稳定的(PS)植入物的结果已经报道[1-8]。然而,仅有少量研究[3,6]报告了长期结果。 Miyasaka等人系列报道了60例膝外翻应用CR模型治疗。经平均13年的随访,他们的膝生存率为91%。在他们的研究,术前胫股角(TFA)平均为17°外翻。生存率是好,由于侧向韧带松弛,术后不稳定率高至24 %。
Elkuset al. [3] described a new soft-tissue release technique and published an excellent 9 year follow-up result with a calculated estimate of 83% survival rate at 15 years without any late medial collateral instability being recorded with a PS implant.
Elkuset Al [3]描述了一种新的软组织松解技术并且报道了15年生存率估计为83%并且无任何晚期的内侧副韧带不稳,记录显示应用了PS植入物。
In their study 42 knees with mean preoperative alignment of 15° valgus were followed up for a
minimum of 5 years with an average of 9 years.Objectives of this study were to examine clinical and radiological long-term outcomes and factors affecting the survival in a primary knee arthroplasty for severe valgus deformities with a cruciateretaining prosthesis.
在他们的研究中42例膝关节术前平均对线为外翻15°,他们被随访了至少5年,平均9年。这项研究旨在调查那些严重外翻畸形而经应用一种十字形保留的假体行主要的膝关节成形术在临床和放射学的长期结果及影响其生存的因素。
2. Patients and methods 患者和方法
2.1. Patients
During the years 1988–2000 a total of 1974 TKAs were performed in our hospital. Of these patients, 176 (9%) had preoperative TFA ≥15°valgus. Ninety-three (53%) patients were either primary OA (n=79) or rheumatoid arthritis (RA) (n=14). Since no significant difference in survival in knee arthroplasty between patients with primary OA or rheumatoid arthritis [9] has been shown therefore the patients with RA were included in to the study.在1988-2000年期间共计1974例TKAs在我们的医院执行了。这些患者, 176 人(9%)有术前TFA ≥15°外翻。 93名(53%)患者是主要的OA (n=79)或风湿性关节炎(RA) (n=14)。因为膝关节成形术在生存上骨关节炎病人和风湿性关节炎病人[9]两者无显著差异,这一点已被证明,所以,风湿性关节炎病人也包括在研究中。
Patients with other diagnoses such as post-traumatic OA and skeletal dysplasias were excluded. Of the 93 patients, 28 had died and 10 patients were bed-ridden in institutions for the elderly due to their old age and poor medical condition. None of the deaths were related to the knee operation.
有其他诊断的病人例如创伤后OA和骨骼发育异常被排除了。在93名患者中, 28人死了,并且10名患者由于他们的年老和恶劣的健康状况被困于为老年人服务机构的床上。死亡病人与膝关节手术无关。
The purpose of this study was to find out the clinical and radiographic results using condylar CR knee designs. Thus we excluded seven patients who had hinge devices (Biomet, Warsaw,
USA. and Waldemar Link, Hamburg, Germany) implanted due to functionally deficient medial collateral ligaments.
这项研究的目的是找出使用髁突CR膝关节设计在临床和放射学的结果。因而我们排除了有铰链设备的七名患者(Biomet,Warsaw,美国。和Waldemar Link, Hamburg,德国)由于内侧副韧带功能上不足被植入。
The remaining 48patients (52 knees) were asked to participate in the clinical follow-up study and 39 patients (43 knees) agreed. All patients were followed for at least 5 years or to first revision. The patients' reasons for being unable to participate in the follow-up study were old age and poor
health in general (n=6) and too long travelling distances (n=3).
剩余的48名患者(52个膝关节)被请求参加临床追踪研究且39名患者(43个膝关节)同意。所有患者被随访了至少5年或到第一次翻修。无法参加追踪研究的患者一般来说是由于年老和恶劣的健康(n=6)和太长的旅程(n=3)。
These nine living patients, who were not able to participate personally in the last follow-up visit, were interviewed by phone and their medical records and radiographs were evaluated. None of the nine had revision surgery and they were satisfied with their TKA. Of the study patients 25 (48%) had flexion contracture mean of 9° (range, 5to 30°).
Demographic data of the patients are given in Table 1.这九名生存患者,没有能亲自参加最后的随访,由电话采访而且他们的病历和放射线照相被评估了。九人都没有行翻修手术,并且对他们的TKA满意。在研究的病人中,25例(48%)存在平均9°(范围5到30°)的屈曲挛缩。患者的人口统计的数据在表1被给。
E. Koskinen et al. / The Knee 18 (2011) 145–150
Fig. 1. a–b: 71-year female with severe valgus deformity. Tibiofemoral angle is 24° (a). Tibiofemoral angle is corrected to 3° (b).
2.2. Study design 研究设计
This was a retrospective follow-up study. Pre- and postoperative data were collected from the patients' records. The physical examination at the last follow-up visit was performed by the first author (E.K.) as an independent observer. The Knee Society Score (KSS) [10,11] was measured preoperatively, at 1 year follow-up, and at the last follow-up, as were weight-bearing anteroposterior (AP) and lateral radiographs as well as long hip-to-ankle mechanical axis radiographs of the leg.
这是一项回顾性追踪研究。术前和术后数据从患者的纪录收集了。体格检查在最后由第一位作者(E.K.)执行,他作为一名独立观察者。
膝关节协会评分(KSS) [10,11]被测量了术前,在1年随访和在最后随访,象前后重量轴承 (AP)和侧位片包含长的髋至踝机械性轴位X片。
At final follow-up a tangential patella (skyline) view [12] was also taken. Radiographs were analyzed by an independent specialist in musculoskeletal radiology (K.T.). The Western Ontario and McMaster Universities Osteoarthritis Index questionnaire (WOMAC) [13] was mailed to the patients along with an invitation to participate in the study. It was completed by the patients at home and returned at the follow-up visit. The answers were checked during the physical examination.
在最后的随访正切髌骨(地平线)图[12]也被采取了。放射线照片由一位独立专家在肌肉与骨骼的放射学(K.T.)方面进行分析。Western Ontario和McMaster 大学骨关节炎索引调查表(WOMAC) [13]被邮寄给患者并邀请参加一起研究。
它由患者在家完成并且在随访时带回。答复者在体格检查期间被检查了。
2.3. Operative technique and postoperative treatment 有效的技术和手术后治疗
The indication for surgery was clinically and radiographically diagnosed severe knee OA or RA with knee symptoms. All patients were operated under spinal or epidural anaesthesia. All knees wereapproached through a medial parapatellar incision. Warsaw
手术指征是临床和影像学被诊断的严重膝关节OA或RA存在膝关节症状。所有患者被管理在脊髓或硬膜外麻醉之下。所有膝关节采用内侧髌旁切口。
A tourniquet wasused in all cases. The implants used in this series were; Interax (Howmedica, Rutherford, USA) in 19, Miller-Galante (Zimmer, , USA) in 14, AGC (Biomet, Warsaw, USA) in 10, Duracon (Howmedica) in seven and NexGen (Zimmer, Warsaw, USA) in two knees. 止血带被用于所有病例。用于这个系列的植入物是; Interax(Howmedica, Rutherford,美国) 19例,米勒Galante (Zimmer,Warsaw,美国)14例, AGC (Biomet,Warsaw,美国) 10例, Duracon (Howmedica)七例和NexGen (Zimmer,Warsaw,美国)二个膝关节。
All implants were CR models. It is assumed that the constraint and conformity of the tibial plateau are similar between implants, noting that the AGC is the least conforming. Numbers were too smallto evaluate association between outcome and implant.
所有植入物是CR模型。它假设,胫骨平台的限制和整合在植入物之间是相似的,注意到, AGC是最不一致。数字太小而不能评估结果和植入物之间的联系。
The posterior-referencing femoral jig was used to determine the size of the component. In the presence of lateral condylar hypoplasia, correct femoral rotation was achieved by adjusting the jig to correspond with the trans-epicondylar axis.
后部参考的股骨夹具用于确定组件的大小。存在横向髁突发育不全时,正确的股骨旋转通过调整夹具与横穿股骨髁上轴一致来完成。
The position of the tibial component was measured using either intra- or extramedullary guides provided by the implant manufacturer. The centre of the rotation was set at the border of medial and central third of the tibial tubercle. There were variations in balancing technique during the
early years of the current series.
胫骨组件的位置可以用植入物制造商提供的髓内髓外指南来测量。旋转的中心被设置在胫骨结节的中间和中央三边界。在当前系列的早期存在平衡技术上的变化。
Two knees had medial collateral ligament tightening. One knee the balancing was done with the
Interax knee (Table 2) with asymmetrical tibial polyethylene liners.
二个膝关节有内侧副韧带紧张。一个膝关节的平衡由Interax所执行(表2)他使用了不对称的胫骨聚乙烯线。
Fig. 1. a–b: 71-year female with severe valgus deformity. Tibiofemoral angle is 24° (a). Tibiofemoral angle is corrected to 3° (b).。 1. a至b : 71岁女性以严重外翻畸形。胫股角是24° (a)。改正胫股角至3° (b)。
However, the balancing technique was similar with the latter part of the series. Ligament balance was assessed at trial reduction and achieved by sequential release of the tight structures in both flexion and extension as described by Whiteside [14].
然而,平衡的技术与系列的后部分是相似的。Whiteside描述韧带平衡被估计在试验减少并且在屈曲和伸展下通过连续放松紧张结构而达平衡。
First, osteophytes were removed under the medial and lateral stabilizing structures. Secondly, the iliotibial band was released by the pie-crusting technique followed by sequential release of the popliteus tendon, fibular collateral ligament, and the gastrocnemius in mid-substance.
首先, 骨赘被移除在中间和侧向稳定的结构之下。第二,髂胫束通过馅饼皮技术被松弛,随之还有腘肌腱、腓侧副韧带和腓肠肌的中间物质被连续地松弛。
If the knee still was tight laterally the posterior capsule was released at the level of the tibial bone cut. The lateral collateral ligament was released, if necessary, from the bony femoral insertion [14]. The posterior cruciate ligament (PCL) was balanced, if necessary, by the pie-crust technique or by a partial detachment of the distal bony insertion with small vertical osteotomy. The lateral soft-tissue releases are outlined in Table 2. Patellar resurfacing was done in all but five knees.
如果膝关节仍然有侧向紧张,后关节囊在胫骨截骨的水平被松弛,如果需要,外侧副韧带从股骨插入[14]。后交叉韧带(PCL)是平衡的,如果有必要,由馅饼皮技术或部分剥离的远侧骨插入与小垂直截骨术。侧向软组织松弛在表2被概述。髌骨置换总计完成五个。
The decision was based on a surgeon's experience and preference. Initially the cement was mixed up in an open bowl. Since 1997 it was mixed in a vacuum chamber and injected onto the washed
and dried bone surfaces.
决定基于外科医生的经验和爱好。最初骨水泥在一个开放碗中混合。自1997年以来它在真空室被混合了并且被注射到被洗涤的和干骨表面。
During the cement hardening the knee was kept in 10°–20° flexion. After polymerisation of the cement, the tourniquet was deflated and hemostasis was performed. Prophylactic antibiotic (cefuroxime or clindamycin) was administered intravenously 1 h before the operation as a single dose.Thromboembolic prophylaxis with subcutaneous heparin or enoxaparin was administered on the day of the operation and was continued daily over the period of the hospital stay. All patients were allowed to walk with full weight-bearing after the surgery.
在水泥硬化期间膝关节保持在10°-20°屈曲。在水泥的聚化以后,松止血带,血被止住了。预防性抗生素(头孢呋辛或氯林霉素)术前1 h静脉内给药,作为唯一药量。下肢静脉血栓预防于皮肤下肝素或依诺肝素在手术那天被执行和每日继续至医院住院期间。所有患者允许术后充分的承重行走。
A continuous-passive-motion machine was used daily during the hospital stay (5 to 10 days). Wound suction drains were used for 48 h. The mean duration of the operation was 115 min (range, 80 to 220 min), and the mean blood loss was 1190 ml (range, 220 to 4100 ml) including blood in drainage after the first 48 h..
每日使用连续被动行动机器在医院住院期间(5到10天)。创伤吸流为48 h.。平均手术时间是115分钟(范围, 80到220分钟),并且平均失血是1190ml(范围, 220到4100ml)包括术后48h内引流出的血液。
2.4. Questionnaires 问卷表
In addition to demographic data, patients were asked to fill in the WOMAC [13,15] questionnaires. The WOMAC has recently been validated in a Finnish population [16]. Scores were calculated for a clinically studied cohort in three dimensions; pain (scale 0–20), stiffness (scale 0–8) and physical function (scale 0–68).The summation score for the WOMAC was also calculated.
除人口统计的数据之外,患者请求填写WOMAC [13,15]问卷表。 WOMAC在芬兰人口[16]最近被确认了。一批做临床研究的人对评分进行了三维计算; 疼痛(标度0-20),僵硬(标度0-8)和身体机能(标度0-68)。总和比分为WOMAC也被计算了。
2.5. Physical examination体格检查
At the follow-up visits the patients were evaluated using a kneesociety rating system [11].
在随访中患者使用膝关节协会的评估系统
2.6. Radiographic evaluation 放射线照片的评估
Radiographic evaluation was performed using the Knee Society radiographic evaluation system [10]. TFA was measured from radiographs as the angle formed at the knee by the intersection of the lines along the centre of the shafts of the femur and tibia. The mechanical axis deviation angle of the extremity is the angle between a line through the centre of the femoral head and the centre of femoral condyles at the top of the intercondylar notch, and a line from this point to the midpoint of the distal joint surface of the tibia [17]. Both the TFA and mechanical axis deviation angle were measured from weight-bearing radiographs.
放射线照片的评估使用膝关节协会放射线照片的评估系统[10]执行了。 TFA由影像学测量是股骨与胫骨中心轴在膝关节所形成的交角。端点机械轴偏差角由两条线所形成,一条是通过股骨头中心及在髁间棘上的股骨髁间中心,另一条是从这点到胫骨远端关节面的中点。TFA和机械轴偏差角两者都是经负重摄片来测量的。
Patellar height was measured according to the method of Insall and Salvati [18]. From a tangential “skyline” view of the patellofemoral joint obtained in recumbent and supine positions the lateral
patellar tilt and displacement were estimated as they are described in the studies of Laurin et al. [12,19]. Component placements and angles were measured according to the Knee Society radiographic evaluation system [10].
髌骨高度的测量方法依据于Insall和Salvati [18]。源于正切“地平线”的观点,髌股关节可在仰卧位时外侧髌骨及位移来进行评估,它们在Laurin等人的研究已被描述。 [12,19]. 组件位置和角度的测量依据膝关节协会影像评价系统。[10]
An analysis for radiolucent lines was made from AP and lateral
radiographs according to the Knee Society radiographic evaluation
system and scoring system for knee arthroplasties [10]. The scoring
system for the arthroplasty components was determined by the width
in millimetres of the radiolucent lines for each of the zones around the
three components. The total widths of every zone for each of the
components were added together to get a numerical value in
millimetres. Four millimetres or less or a non-progressive sum of
the radiolucent lines was considered not significant. Five to 9 mm was
possibly significant, and 10 mm or greater was defined as failing
regardless of symptoms. The presence and degree of heterotopic
ossification were classified according to the morphologic patterns as
described by Harwin et al. [20].
一份关于X线的分析由AP所作,侧向X线片根据膝关节协会影像评价和膝关节成形术[10]组件的评分系统取决于三个组件附近的每一个区域X线毫米宽度。总宽度为每一个组件每个区域加起来得到一个数值。四毫米或更少或者非进展X线总和被认为是不显著的。5~9mm可能是显著的,10mm或更多被定义为不得不管的症状。异位骨化的出现和程度依据Harwin等人所描述的形态样式分类。[20].
2.7. Statistical analysis统计分析
The statistical analyses were performed using SPSS 12.0.1 for Windows (SPSS Inc., Chicago, Illinois). Statistical tests used were Student's t-test and Chi-square test with correction for unequal
variances as necessary. Associations between categorical variables were analyzed by the Chi-square test or Fisher's exact test, whichever was appropriate. The independent paired sample t-test was applied for comparisons between two normally distributed groups. When the
distributions were skewed, the Mann–Whitney U-test was applied. Endpoints for survivals were defined as revision for any reason and revision for instability. Both survivals were calculated. Also early survival rate at 5-year for the first 26 and for the last 26 operated patients were calculated to investigate if there was a difference in survival as the surgical experience increased. The survivorship analysis was performed according to the method of Kaplan and Meier [21]. A failure was defined as a revision of the implant or pending revision.
统计分析处理利用SPSS 12.0.1窗口(SPSS 软件公司,芝加哥,伊利诺伊)。 使用的统计测试如所需要是学生的t-检验和卡方测定以纠不等同的方差,分类变量间的联系
由卡方检验或Fisher确切测验来分析,无论哪种都是适当的。 独立配对样本t检验是应用比较两组之间呈正态分布
。 当分布规律偏斜,曼惠特尼U检验被应用。生存的终点为,任何原因的翻修和因不稳而翻修。两个生存时间被计算了。 并且早期生存率为5年的最初的26例和最后26例手术患者被计算调查,如果有生存上的区别,也是因为手术经验增加了。生存率分析用卡普兰和Meier的方法执行[21]。 失败病例为:被确定植入物翻修或等待翻修。
2.8. Ethical aspects 伦理方面
Informed consent was obtained from all participants. The authors obtained permission to perform this study from the ethics committee of the hospital district where the study was conducted (Dnro HUS 408/E6/04).所有参与者获得了知情同意。作者从地区医院道德委员会获得了允许进行这项研究,研究也在该院进行(Dnro 医院 408/E6/04)。
3. Results结果
3.1. Knee score 膝关节评分
Results from the physical examination are given in Table 3. Preoperatively 25 of the
52 knees had an extension lag with an average of 9° (range, 5° to 30°). At the last
follow-up visit four knees out of 52 had an extension lag with an average of 1° (range,
0° to 15°). The mean clinical and functional KSS declined from 77 and 89 points at oneyear
follow-up, to 59 and 64 points respectively at the last follow-up visit (p=0.007
and p=0.009).体格检查结果在表3给出。 52个膝关节中有25个存在术前伸膝不全,平均9° (范围, 5°对30°)。在最后的随访中52个膝关节中有4个有平均1° (范围,0°对15°) 的伸膝不全。平均的临床和功能KSS从一年时随访的77和89分分别下降到最后随访的59和64分(p=0.007和p=0.009)。
Table 3
Knee Society Scores and active range of motion preoperatively, 1-year postoperatively
and at the last follow-up visit.
膝关节协会评分和术前行动的活跃范围,术后一年和在最后的随访。
3.2. WOMAC questionnaire WOMAC 问卷表
The WOMAC was completed by the patients at home and returned at the last
follow-up visit. The mean scale for pain was four points (range, zero to 16 points), themean scale for stiffness was two points (range, zero to four points) and for physical function 24 points (range, one to 62 points). The mean summation score was 30 points (range, one to 78 points). There was a correlation between the WOMAC and the KSS (p=0.001).
WOMAC由患者在家完成并且在最后的随访时被送回。平均分数中痛苦是四分(范围,零到16分),僵硬是二分(范围,零到四分),生理功能24分(范围,一到62分。分均总比分是30分(范围,一到78分)。WOMAC和KSS (p=0.001)之间存在相关性。
3.3. Survival rate 生存率
Fourteen of the 52 knees had been revised during follow-up thus revision rate of the whole study population was 27%. Reasons for revision are given in Table 4. One of the patients had fallen during the follow-up and was operated on for a periprosthetic fracture and two patients had revision due to a metal-backed patella button.
52个膝关节中有14个在随访期间翻修,在整个研究人群中翻修率是27%。翻修的原因在表4被给。其中一名患者在随访期间摔落而因假体周围骨折施行手术,另二名患者翻修是由于一个金属支持的膑骨按钮。
The Kaplan–Meier analysis revealed 79% (95% Confidence Interval (CI) 68% to 91%) survival
rate with revision for any reason and 81% (95% CI 70% to 93%) survival rate with
revision for instability as an endpoint at ten years (Fig. 2). Survival rate with revision for
any reason at 13 years was 74% (95% CI 59% to 89%). 5-year survival rates for the first 26
and for the last 26 operated patients of the study were 73% (95% CI 56 to 90) and 96%
(95% CI 88 to 100). Meier分析显示了79% (95%可信区间(CI) 68%到91%)
生存率以任何原因而翻修和81%卡普兰 (95% CI 70to 93%)生存率以不稳定原因、以十年作为终点而翻修(表。 2). 生存率以任何原因、在13年时翻修是74% (95% CI 59%到89%)。 5年生存率在最早的26名和为研究的最后26名手术患者是73% (95% CI 56%到90%)和96%
(95% CI 88%到100%)。
3.4. Radiographic results 放射学结果
Tibiofemoral angle of the valgus knees averaged 23° (range, 15° to 51°) preoperatively and 7° (range, 21° valgus–4° varus) valgus postoperatively. Postoperatively 33 of the 52 knees had tibiofemoral alignment between 3° and 9° valgus. Seven patients had a decreased valgus alignment in the tibiofemoral joint (mechanical axis in varus) (b3° valgus angle) and 12 patients had an increased valgus alignment (N9° valgus).
胫股角术前平均为膝外翻23°(范围,15°至51°)而术后外翻 7°(范围,21°外翻-4°内翻)。 52个膝盖中33个术后有胫股l对准线在3°和9°外翻之间。七名患者在胫股联合(机械轴以内) (b3°外翻角)外翻对准线有减少,且12名患者有增加的外翻对准线(N9°外翻)。
The tibiofemoral angle, mechanical axis, femoral and tibial angle in addition to femoral flexion angle and posterior slope measurements are given in Table 5. The mean amount of patellar component tilt in relation to the femoral component was 4° (range, ?8° to 10°), and the mean postoperative displacement of the patella according to Laurin et al. [12,19] was 3 mm(range,?5 to 60 mm) at the last visit. Three patients had a subluxation of 10–15 mm without any clinical signs and one patient had a permanent luxation, but due to old age (82 years) she was not willing to undergo any re-operations and was able to walk with crutches.
胫股角、机械轴、股骨和胫骨角度除股骨弯曲角度之外还有后部倾斜测量在表5给出。
与股骨组件有关的髌骨组件倾斜度数平均是4° (范围, ?8°至10°),且髌骨的平均术后位移据Laurin等人[12,19] 描述在最后随访时是3毫米(范围, ?5到60毫米)。
三名患者有10-15毫米的半脱位,无任何临床征象,并且一名患者有永久性脱位,但由于年老(82岁)她不愿意接受任何再手术并且她能用拐杖行走。
There were no complete radiolucent lines around any component in any knee
The tibiofemoral angle, mechanical axis, femoral and tibial angle in addition to femoral flexion angle and posterior slope measurements are given in Table 5. The mean amount of patellar component tilt in relation to the femoral component was 4° (range, ?8° to 10°), and the mean postoperative displacement of the patella according to Laurin et al. [12,19] was 3 mm(range,?5 to 60 mm) at the last visit. Three patients had a subluxation of 10–15 mm without any clinical signs and one patient had a permanent luxation, but due to old age (82 years) she was not willing to undergo any re-operations and was able to walk with crutches
There were no complete radiolucent lines around any component in any knee
during the follow-up period, and all local radiolucent lines were b2 mm wide. There
was no migration or subsidence of any component in any knee. No heterotopic bone
formation of the joints was noted.
随访期间,没有完整的放射线在任何膝关节的任何组件周围,并且所有局部放射线是b2毫米宽。
任何膝关节的任何组件均无移位及下沉。没有关节异位骨化形成被提及。
3.5. Revisions and complications 翻修和并发症
Of the 52 knees, 14 were revised during the follow-up period. Of them, eight were revised because of the progressive postoperative medial collateral laxity, and all these revisions were performed during the first four years postoperatively (Table 4). For those eight patients the mean tibiofemoral angle was 16° (range, 3° to 21° valgus) valgus. The odds ratio (OR) for a revision among these subjects with a postoperative medial collateral instability was 2 (95% CI 1–3, p=0.025) when compared to the rest of the 44 studied. There was no difference in revision rates between patients with or without lateral collateral release (pN0.05).
在随访期间, 52个膝关节中14个被翻修了。他们中八个被翻修是由于进行性的术后内侧副韧带松驰,所有这些翻修术执行于术后第一个四年期间(表4)。那八名患者平均胫股角是16° (范围, 3°至21°外翻)外翻。与其余被研究的44个比较,在这课题中因术后内侧副韧带松驰而行翻修的可能性比率(或)是2 (95% CI 1-3, p=0.025)。患者有或无侧向附属结构松驰(pN0.05)对翻修率没有区别。
One knee had lateral wear of the all-polyethylene type of liner and had to be
revised. One knee was revised because of lateral collateral instability. Postoperative
tibiofemoral angle was 1° varus in that patient. One knee had both anteroposterior and
medio-lateral instability which was stabilized by exchanging to a thicker polyethylene
liner. One of the patients had fallen during the follow-up and was operated on for a
periprosthetic fracture and two patients had revision due to metal-backed patella.
Revisions and their reasons are summarized in Table 4.
膝关节存在全聚乙烯衬垫的侧向磨损,就必须被翻修。膝关节翻修可因为侧向附属结构不稳定。那名患者术后胫股角是1°内翻。膝关节同时有前后和中间-侧向不稳,为使稳定,用一加厚的聚乙烯衬垫来更换。其中一名患者在随访期间摔落而因假体周围骨折施行手术,另二名患者翻修是由于一个金属支持髌骨。翻修和它们的原因在表4总结。
Two knees were revised twice. One was first revised due to instability; a thicker
liner was administered and the situation improved. The patient, however, then fell
down and had a periprosthetic fracture and had to be revised again for a hinged
prosthesis. The other patient was first revised and administered with a thicker liner due
to instability of the tibiofemoral joint. The same patient was then revised again after
6 years and treated with TC-3 implant due to residual instability.
During the follow-up none of the patients had superficial or deep infections,
permanent peroneal palsies, deep venous thromboses or pulmonary embolism. One
patient (2%) had a transient peroneal palsy.
二个膝关节翻修了两次。一个第一次翻修是由于不稳定; 换了个加厚的衬垫,情况改善了。然而,该患者跌倒了并引起假体周围骨折不得不使用铰链式假体翻修。另一名患者首次翻修用加厚的衬垫是由于胫股联接的不稳定。同一名患者在6年后再次被翻修并且用TC-3植入物以治疗残余不稳。
在随访期间患者都没有表面或深部的感染、永久腓侧麻痹、深静脉血栓形成或者肺栓塞。一名患者(2%)有暂时的腓侧麻痹。
4. Discussion 讨论
This was a retrospective study involving a long-term follow-up. We have preferred to use a CR model in valgus patients in order to save bone stock for future possible needs. The mean preoperative tibiofemoral valgus angle (23°) in this study is the highest reported in
the literature. The Kaplan–Meier analysis revealed 79% survival rate with revision for any reason as an endpoint at 10 years. This is the lowest survival reported [3,5,6]. The most important observation in the study was the residual valgus as the main reason for an earlyrevision.
这是一项回顾性研究涉及一项长期随访。
我们更愿意使用CR模型于外翻患者为了保存骨量以为将来所需。
平均术前胫股外翻角(23°)在这项研究中是文献报道中最高的。
卡普兰Meier分析显示了79% 生存率以任何原因而翻修以10年作为终点。这是被报告的
最低的生存率[3,5,6]。在研究中最重要的观察是残余的外翻作为一个早期翻修的主要原因。
Flexion contracture may have had effect on radiographic results as
the valgus deformity may have been more pronounced in the
radiographs. Augmentation of the deficient condyle with bone graft
or metal blocks was not necessary in our series. Clinical and
radiological examinations were performed by independent observer.
The participation rate was high. The WOMAC questionnaire was not
available at the time of the first operation and the validated Finnish
version has only been available for a short time.
屈曲挛缩可能对影像学结果产生影响,因为外翻畸形在照片中可能更明显。
为增加髁部缺失而使用骨移植或金属块在我们系列中不是必需的。
临床和放射学检验由独立观察执行。参与率高。 WOMAC调查表在第一次运行时是不可用的,并且被确认的芬兰语版本只短时间是可利用的。
After the one-year follow-up the mean clinical and functional KSS were 78 and 89 points declining to 58 and 62 points respectively at the latest follow-up visit. It seems that during a long follow-up period some patients' overall health had declined and this had an influence to the KSS. The health status of patients operated on 2 or 5 years ago has been reported to be similar, suggesting that health gains persist for several years; however, the real long-term observations are still lacking [22,23].Krackow et al. [5] have reported clinical results of 81 patients with a mean preoperative tibiofemoral angle of 18° but they did not present any survival rates. They had the mean postoperative knee score 88 for the valgus group and 93 for the control group compared to 75 in our study. The functional KSS in their study was postoperatively 52 points, for a mean increase of 18 points from the preoperative score. Elkus et al. [3] have published results from a minimum of 5 years follow-up with a 15° preoperative TFA showing an estimated survival rate of 83% at 15 years. They used posterior stabilized models only. In their study the KSS improved from 30 points preoperatively to 93 points postoperatively, and the mean functional KSS improved from 34 to 81. In this study functional KSS improved from 39 to 89.
在1年的随访以后平均临床和功能KSS评分是78和89分,到最后的随访分别下降到58和62分。
看起来在长期随访期间有些患者的整体健康下降了,这对KSS评分有影响。
患者的健康状态与2或5年前手术时的报告是相似的,表面健康进步持续多年; 然而,真正的长期观察仍然缺乏[22,23]。
Krackow等人 [5]报告了81名病人的临床结果是平均胫股角度18°,但他们没有提到任何生存率。
他们的外翻小组手术后平均膝关节比分为88分,控制小组为93分,与之相比较,在我们的
研究中是75分。
功能KSS评分,在他们的研究中术后是52分,较术前平均增长18分。
Elkus等人[3]公布的结果为术前15°胫股角最少5年随访并显示了15年生存率估计为83%。
他们仅使用了后部稳定的模型。
在他们的研究中KSS评分从术前的30分提高至术后的93分,平均功能KSS评分从34分提高到81分。在这项研究中功能KSS从39分提高到89分。
Miyasaka et al. [6] are the only authors reporting long-term results with a CR model used in 60 arthroplasties. Although the survival rate was good (91% at 13 years) the rate of postoperative
instability was a problem (24%). According to their discussion it was due to the extensive lateral ligament release which differed from the technique of the present study. In their material only three knees (5%) had over 10° of valgus (all measuring 13°) postoperatively. In our study twelve (23%) had a residual valgus over 9°. We did not observe any postoperative instability if the TFA correction gained was within a range of ≤9°–0° valgus. However, the postoperative
range of TFA angle in our study is not acceptable in modern arthroplasty surgery.There have been reports of peroneal nerve injuries in 0.5 to 1% of patients after TKA, and patients with preoperative valgus deformity and flexion contractures are especially at risk [24–26]. However, the peroneal nerve injury after the valgus knee arthroplasty has always been classified as a neurapraxy with a favorable prognosis to heal. In our study, one patient had a transient palsy which healed entirely. None had permanent peroneal palsy as a complication.
Miyasaka等人 [6]是唯一报道的作者,他们报告了60例关节成形术中使用CR模型的长期结果。虽然生存率是好(91%在13年)但术后不稳定率是个问题(24%)。根据他们的讨论它归结于广泛的侧向韧带松弛,它不同于本研究的技术。
在他们的资料中仅三例膝关节(5%)存在术后超过10°外翻 (所有测量的13°)。在我们的研究中十二例(23%)有一残余的外翻9°以上。
如果TFA获得更正在≤9°-0°外翻之内的范围,我们没有观察到任何术后不稳定。
然而,在我们的研究中术后TFA角的范围对现代关节成形术不是可接受的。
据报告在施行TKA以后的患者中有0.5%到1%的腓总神经损伤,术前有外翻畸形和屈曲挛缩的病人特别有危险[24-26]。
然而,在外翻膝关节成形术后的腓总神经损伤一直是归为机能性麻痹,具有良好的治疗和预后。
在我们的研究中,一名患者有短暂麻痹,后来完全治愈。没有出现永久性腓神经麻痹这一并发症。
The objective of the present study was to evaluate results of the CR design in patients with severe valgus deformity. Our 81% cumulative survival rate for any reason calculated from the Kaplan–Meier analysis for ten years in severe valgus deformity knees seems not to justify the common use of cruciate-retaining prosthesis. Survival even declined during longer follow-up; survival for any reason was 74% (95% CI 59% to 89%) at 13 years (Fig. 2). This was directly or indirectly due to
polyethylene wear from the liner (Table 4). However, the most common reason for revision was medial collateral instability. Patients re-operated for a medial collateral instability were mainly from the early years of the current series. Number of early revisions due to medial collateral instability decreased markedly as the experience increased. It seems that these revisions were due to surgical errors and might have been avoided using more proper surgical technique (i.e. more soft-tissue releases and thicker polyethylene liner) and/or TC-3 or hinged designs. There were no revisions due to insufficient posterior cruciate ligament. A reason to favor cruciate-retaining
designs is the preservation of bone in condyles for possible revisions in the future, especially among younger patients.
本研究的宗旨是评估CR设计对严重外翻畸形病人的结果。
我们的累计生存率是81%,任何原因均计算在内,从Kaplan–Meier十年来对严重膝外翻畸形的分析来看,没有被证明十字型保留假体普遍使用。
在更长的随访期间,生存率甚而下降; 所有原因的13年生存率为74% (95% 可信区间59%
到89%)在 (图 2).
这直接地或间接地是由于聚乙烯从衬垫的磨损(表4)。
然而,翻修的最普遍的原因是中间附属结构不稳。
患者因内侧副韧带不稳再手术是主要从当前系列的早期。当经验增加了,因内侧副韧带不稳早期翻修的数字明显减少了。
看起来这些翻修归结于手术错误,并且也许使用更加适当的外科技术它已经被避免了
(即更多软组织放松和加厚的聚乙烯衬垫)并且/或者TC-3或者铰链式设计。
没有因为后十字韧带不足而翻修的。支持的原因是十字形保留设计为将来可能的翻修保存了髁突的骨质,特别是在更年轻的患者之中。
Residual valgus was a clear predisposing factor for early revision
(Fig. 3a–c). Returning the knee alignment into 5–7° of valgus may be
difficult; in our study the postoperative variance of tibiofemoral
angle was quite high too. Statistically, patients with excess residual
valgus deformity had almost two times (OR 2) higher risk for
revision when compared to those cases where anatomic loading axis
could have been restored.
残余的外翻是早期翻修的一个明确诱因(图 3a-c)。返回膝关节对准线至外翻 5-7°也许是困难的; 在我们的研究中胫股角术后变化也是相当高。
统计表明,患者过量残余外翻畸形几乎是两倍(OR2)的更高风险的翻修,与那些病例相比,解剖重量轴可能已经恢复。
Fig. 3. a–c: 64-year female with severe valgus deformity. Tibiofemoral angle is 26° (a). Tibiofemoral angle is under corrected to 12° (b) and then 20° after 3 years and revised due tomedial collateral instability.
To avoid residual valgus deformity it has also been proposed that distal femoral resection should be performed with 2° of overcorrection to maximize restoration of the mechanical axis [27]. One patient was revised because of the lateral collateral instability. In that patient a predisposing factor for the revision was postoperative tibiofemoral angle in 1° varus (mechanical axis in 5° varus).
要避免残余的畸形它有提议执行末端股骨切除以过度矫正 2°,最大化恢复机械轴[27]。
由于侧向附属结构不稳,一名患者被翻修了。那名患者翻修的诱因为术后胫股角为内翻1° (机械轴在内翻5°内)。
In one patient the proximal advancement of the medial collateral ligament in the distal femur was done, and in one patient medial side was tensioned with tightening sutures [28]. Experiences in our institute do not favor the use of these techniques i.e. badly attenuated ligamentous tissue has lost its normal elasticity and cannot resist the load. This is obvious especially in cases where too much residual valgus stress is left.
一名患者通过末端股骨截骨外移内侧副韧带,一名患者通过内侧边拉紧缝合[28]。在我们学院的经验不倾向用这些技术的用途即韧带组织严重变细而丢失了它的正常弹性,难以抵抗负荷。这是显然的,尤其是在太多残余的外翻应力存在时。
In conclusion, this series of patients shows that when using the CR type of total knee prosthesis the proper bony resections with adequate soft-tissue balancing are necessary for accepted
long-term survival of the TKA. There was a clear learning curve in the beginning of the series. If proper soft-tissue balance cannot achieve or there is no functional medial collateral ligament more constrained implants (TC-3 or hinged) should be used instead of CR-arthroplasty.
总而言之,这一系列患者显示当使用CR型全膝假体,恰当的骨切除及适当的软组织平衡,对于可接受的TKA长期生存是必要的。
在系列的起点有一条清楚的经验曲线。如果适当的软组织平衡不能达到或内侧副韧带没有
功能,那么更有约束力的植入物(TC-3或铰链式)应该使用以替代CR关节成形术。
On the other hand, in cases with type I and in at least part of the type II valgus knees where both bony correction and ligament balancing have properly been achieved the use of CR type of prosthesis is justified.
另一方面,I型病例和至少一部分II型膝外翻,两者均使用了被正确接受的CR型假体进行了骨纠正和韧带平衡,这是合理的。
5. Conflict of interest 利益冲突
No competing interests declared.声明没有利益冲突。
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