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[用于全膝关节置换术的Medin模块化植入物——中期结果]

[Medin modular implant for total knee arthroplasty--mid-term results].

作者信息

Vavrík P, Landor I, Tomaides J, Popelka S

机构信息

I. ortopedická klinika 1. LF UK a FN Motol, Praha.

出版信息

Acta Chir Orthop Traumatol Cech. 2009 Feb;76(1):30-4.

Abstract

PURPOSE OF THE STUDY To evaluate the mid-term results of total knee arthroplasty (TKA) using a Medin Modular joint prosthesis in a standard design preserving the posterior cruciate ligament. MATERIAL The study comprised 206 consecutive total knee arthroplasties, 10 bilateral, 60 in men and 136 in women. Twelve patients died of causes unrelated to the surgery and 14 knee replacements were lost to follow-up. A total of 180 were evaluated at an average follow-up of 6.5 years (range, 5 to 8.7 years). The patients ranged in age from 43 to 84 years (average, 69.5 years). The basic indication for surgery was osteoarthritis in 179 and rheumatoid arthritis in 37 cases. METHODS Pain, range of motion, stability and function were scored on a 100-point scale of the Hospital for Special Surgery (HSS) Scoring System. Subjective satisfaction was essessed by the patient's willingness to undergo the surgery again. At yearly intervals, radiographs in two projections were examined for radiolucent lines around the implant. The Kaplan-Meier survival curve was evaluated for the whole group and compared with that for non-infected cases only. The mechanical properties of the implant were most reliably shown by the survival curve for the subgroup of knee replacements free of infection. RESULTS At the final follow-up out of 180 knees, 169 were fully functioning and 11 required revision arthroplasty for the following reasons: polyethylene wear, one knee; instability, two; infection, six; patellar fracture, one; and problems associated with the femoro-patellar joint, one knee. The Kaplan-Meier curve for the whole group showed survival of 92 % of the implants at the end of the 9-years follow-up time. In the infection-free subgroup, in which aseptic loosenings were only included, there was a 95 % survival. The average range of flexion was over 106 degrees, and only 11 knees had flexion below 90 degree lack of. Extension from 5 to 10 degrees was found in four knees. Thirteen knees showed instability that did not interfere with function. In 191 knees, after surgery alignment was optimal, between 0 and 5-degree valgus; in 11 knees varus up to 5 degrees and valgus up to 10 degrees were found. No pain was recorded in 123 knees, occasional pain with no effect on function in 36 cases, and moderate pain after weight-bearing in 10 knees. By the HSS score, 136 knees had excellent and very good (over 90 points) outcomes and 21 had unsatisfactory or poor outcomes (below 85 points); the remaining 23 had satisfactory outcomes (between 89 and 85 points). The subjective evaluation was positive for 156 knees. Of 169 TKA evaluated radiographs, 141 were without signs of radiolucency, 17 showed a slight marginal radiolucent line and 11 had a more pronounced radiolucent line up to 1 mm in width, but without progression. DISCUSSION A total of 93 % of total replacements were evaluated and 7 % were lost to follow-up. Therefore, the number of remaining patients is big enough to make the group valid for assessment. The rate of complications, including 2.9 % of infected knees, is in agreement with the reported values. The occurence of polyethylene wear was negligible. A comparison of the cumulative survival curve for the whole group with that for the infection-free subgroup showed that the effect of infection on the TKA outcome was statistically significant (p=0.0431), and that late infection remains the most serious complication. Aseptic loosening plays a less important role in implant survival evaluated at mid-term intervals. CONCLUSIONS The rate of complications for Medin Modular implants evaluated at an average follow-up of 6.5 years is not different from the values reported for similar prostheses. The most serious complication is late infection. Persistent pain is usually located to the femoro-patellar articulation, but it seldom markedly affects joint function. The cumulative survival curve for the whole group was 92 % at a 9 years. The HSS evaluation of the whole group showed that 75 % of the knees achieved mor than 90 points.

摘要

研究目的

评估采用Medin模块化关节假体进行保留后交叉韧带的标准设计全膝关节置换术(TKA)的中期结果。材料:该研究纳入206例连续的全膝关节置换术患者,其中10例为双侧置换,男性60例,女性136例。12例患者死于与手术无关的原因,14例膝关节置换失访。共180例患者接受评估,平均随访6.5年(范围5至8.7年)。患者年龄43至84岁(平均69.5岁)。手术的基本指征为骨关节炎179例,类风湿关节炎37例。方法:采用特殊外科医院(HSS)评分系统的100分制对疼痛、活动范围、稳定性和功能进行评分。通过患者是否愿意再次接受手术评估主观满意度。每年间隔拍摄两个投照位的X线片,检查植入物周围的透亮线。对全组进行Kaplan-Meier生存曲线评估,并与仅非感染病例的曲线进行比较。无感染的膝关节置换亚组的生存曲线最可靠地显示了植入物的力学性能。结果:在180例膝关节的最终随访中,169例功能完全正常,11例因以下原因需要翻修置换术:聚乙烯磨损1例;不稳定2例;感染6例;髌骨骨折1例;股骨髌骨关节相关问题1例。全组的Kaplan-Meier曲线显示,在9年随访期末植入物的生存率为92%。在仅包括无菌性松动的无感染亚组中,生存率为95%。平均屈曲范围超过106度,仅11例膝关节屈曲低于90度。4例膝关节伸直受限5至10度。13例膝关节有不影响功能的不稳定。191例膝关节术后对线最佳,外翻0至5度;11例膝关节有内翻达5度和外翻达10度。123例膝关节无疼痛记录,36例偶尔疼痛但对功能无影响,10例负重后中度疼痛。根据HSS评分,136例膝关节结果为优或良(超过90分),21例结果不满意或差(低于85分);其余23例结果满意(85至89分)。主观评估中156例膝关节为阳性。在169例评估的TKA中,141例X线片无透亮线迹象,17例有轻微边缘透亮线,11例有更明显的透亮线,宽度达1mm,但无进展。讨论:共93%的全膝关节置换患者接受评估,7%失访。因此,剩余患者数量足以使该组有评估价值。并发症发生率,包括2.9%的感染膝关节,与报道值一致。聚乙烯磨损的发生率可忽略不计。全组累积生存曲线与无感染亚组的比较显示,感染对TKA结果的影响具有统计学意义(p = 0.0431),晚期感染仍然是最严重的并发症。在中期评估植入物生存时,无菌性松动起的作用较小。结论:平均随访6.5年评估的Medin模块化植入物的并发症发生率与类似假体报道的值无差异。最严重的并发症是晚期感染。持续性疼痛通常位于股骨髌骨关节,但很少明显影响关节功能。全组9年的累积生存曲线为92%。全组的HSS评估显示75%的膝关节得分超过90分。

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